Jump to content

Example Queries: Difference between revisions

From CAMIH
Line 62: Line 62:
  [[has subobject.Reference.Topic::Vitamin D]]
  [[has subobject.Reference.Topic::Vitamin D]]
  |?has subobject.Dosage and regime
  |?has subobject.Dosage and regime
|limit=3
  |headers=plain
  |headers=plain
}}
}}
== Für/gegen was ist die Einnahme von Aloe empfehlenswert? ==
== Für/gegen was ist die Einnahme von Aloe empfehlenswert? ==
{{#ask:
{{#ask:

Revision as of 13:37, 14 November 2024

Welche Indikationen gibt es für die Einnahme von Selen?

 Outcome nameOutcome specificationResults after interventionOverall RoB judgment
Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patientsToxicity
Ejection fraction
Infectionrate after chemotherapy
Cardiac ejection fraction
NA
NA
high risk
high risk
Büntzel et al. (2010): Limited effects of selenium in the prevention of radiation-associated toxicities - results of a randomized study in head neck cancer patientsToxicityGrade of radiotherapy-associated side effects: Xerostomia, stomatitis, ageusia, and dysphagiaNo significant differences; overall number of serious adverse events, not significantly different: intervention arm 23x and control arm 22x (p=0.476)some concerns
Büntzel et al. (2010): Selenium Substitution During Radiotherapy of Solid Tumours - Laboratory Data from Two Observation Studies in Gynaecological and Head and Neck Cancer PatientsSelenium levelSerum concentration and whole blood concentrationAt 6 weeks after irradiation no significant differences; Significant differences in selenium concentrations (serum and blood) at the end of radiotherapy (p<0.0001)NA
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer TrialRFS (Recurrence-Free Survival)
PFS (Progression-Free Survival)
Selenium level
NA
NA
Measured at baseline and after 3 years
ITT: intervention arm n=43 (28%; 95% CI: 0.21, 0.35) and placebo arm n=45 (32%; 95% CI: 0.24, 0.40); HR: 0.85 (95% CI: 0.56, 1.29); p=0.44, not significant

PP: (all participants remaining in the study after 3 months): intervention arm n=42 and placebo arm n=39 (28%; 95% CI: 0.20, 0.35); HR: 0.96 (95% CI: 0.62, 1.48)); p=0.85, not significant

No influence of age, gender, nicotine consumption, stage, selenium concentration at baseline and hospital
Remark: After 3 months: progression in 24 patients, median progression time 22 months in both arms; Patients in intervention arm had 48% more chance of progression than those in the placebo arm, but not statistically significant (HR = 1.48 (95% CI: 0.65, 3.38); p=0.35);

Progression in the intervention arm 15x, placebo arm 14x ITT: HR: 0.97 (95% CI: 0.47, 2.00); p=0.93, not significant
Significant difference in selenium concentration after 3 years (n=67 (55%)): 187.6 mg/dl ± 57.7 mg/dl intervention arm vs. 88.9 mg/dl ± 22.2 mg/dl placebo arm; p=0.00
some concerns
some concerns
some concerns
Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trialHaematological indices
Length of hospital stay
Incidence of acute GVHD (Graft-Versus-Host Disease)
Mortality rate
Non-haematological indices
Selenium level
Mucositis
Fever
Neutrophil and platelet engraftment time (the time point after transplantation at which a patient can maintain a sustained ANC of 4500 cells/mm3 and a sustained platelet count of at least 20 000/mm3 lasting 3 consecutive days without transfusions during hospital stay)
NA
Graft-versus-host disease is a condition where the donated stem cells (graft) attack the recipient's body (host)
At 3 months
Serum creatinine level and blood urea nitrogen test for renal function assessment and aspartate aminotransferase and alanine transaminase for liver function assessment, recorded daily
NA
Oral Mucositis
Duration of fever
NA
No difference between selenium arm (26.92±6.26 days) and placebo arm (25.81±4.33 days); p=0.38
Overall: No difference between the arms; p= 0.35
No difference between the arms; p= 0.69
Overall: No difference between arms for increase in serum creatinine; p=0.31 or increase in aspartate aminotransferase and alanine transaminase: p=0.62
Significant difference in mean serum selenium level between two arms at 14 days after transplantation (8.34 mcg/dL in the selenium arm vs 7.36 mcg/dL in the placebo arm), p=0.018
Overall: Cumulative incidence (grade 1-4) comparable in both selenium arm (83.8%) and placebo arm (81.1%); p=0.76; grade 3-4 mucositis significantly lower in selenium arm (10.8%) compared to placebo arm (35.1%); p=0.013 (grade 4: 2x in placebo arm, 0x in selenium arm)


Mean duration comparable (p=0.048), only duration of objective mucositis from grade 2 to 4 and back was significantly shorter in the selenium arm (3.6±1.84 days) than in the placebo arm (5.3±2.2 days); p=0.014
NA
some concerns
some concerns
some concerns
some concerns
some concerns
some concerns
high risk
some concerns
Karp et al. (2012): Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597OS (Overall Survival)
Toxicity
Selenium level
DFS (Disease-Free Survival)
5-year OS
NA
NA
DFS Randomization until secondary tumors or recurrence and 5-year DFS
Intervention arm: 76.8% (SE, 1.6%) vs. placebo arm: 79.9% (SE, 2.1%); p=0.154


Note: Distribution significantly different for smoking status (p=0.027): active smokers or those who had quit within one year showed a 3-year OS of 85.5% (SE, 1.7%) and 5-year OS of 74.9% (SE, 2.4%), whereas participants who had never smoked showed a 3-year OS of 90% (SE, 2.8%) and a 5-year OS of 83.6% (SE, 3.6%); no difference for DFS; p=0.245
Collected in 865 patients in intervention arm and 477 in placebo arm:

  • Grade 1-2 toxicity in intervention arm: 31% and placebo arm: 26% of subjects
  • Grade ≥ 3 toxicity occurred in less than 2% of subjects in intervention arm and 3% in placebo arm
  • n=1 patient in placebo arm had constitutional lethal toxicity
  • no arm comparison performed
    Selenium level at baseline (n=1,022), year 2 (n=375), and year 4 (n=194): at baseline selenium level mostly in normal range, after 2 and 4 years significantly increased selenium concentration in the intervention arm
    Interim analysis October 2009:

N=83 secondary lung tumors; Rate intervention arm: 1.91 per 100 persons per year vs. 1.36 in placebo arm; p=ns


June 2011: N=252 secondary tumors in 224 patients, of which 98 (out of 97 patients) were lung cancer (38.9%); Lung cancer and other cancers (SPT) in intervention arm: 1.62 and 3.54 per 100 persons per year vs. placebo arm: 1.30 and 3.39 per 100 persons per year; p=0.294


5-year DFS: October 2009: Intervention arm: 72% vs. placebo arm: 78%, no significance values given


June 2011: Intervention arm: 74.4% vs. placebo arm: 79.6%; p=0.69


Note: 5-year DFS rates with subdivision into low, average and high selenium concentration intervention vs. placebo: 75.5% (SE, 10.3%) vs. 72.9% (SE, 12.7%), 75.6% (SE, 2.27%) vs. 78.2% (SE, 3.3%), and 72.9% (SE, 4.5%) vs. 80.9% (SE, 5.2%)
low risk
low risk
low risk
low risk
Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck CancerSelenium level
Mucositis
NA
Inflammation of the oral mucosa (mucositis) due to radiotherapy
At the end of radiation (after 7 weeks) there was no difference in the mean serum selenium level between the selenium arm and placebo arm (p=0.24)

Based on the selenium level before radiation, developing severe oral mucositis was statistically significant postponed in patients who had selenium levels ≥ 65 mcg/L (p=0.04)
After 7 weeks no significant differences between the selenium arm and the placebo arm for:

  • mean duration of oral mucositis (grade 1–4) (p=0.27)
  • onset of oral mucosits (p =0.31)
  • recovery (day after radiation completion (p=0.80)
  • cumulative incidence of oral mucusitis (grade 1–4) (p=0.79)


Severe oral mucositis (grade 3 or 4) was seen in 25 patients in the selenium arm and in 20 patients in the placebo arm.


Addition: Development of oral mucositis in patients with selenium levels >65 mcg/l significantly delayed from baseline (p=0.04, no further explanation given)
NA
high risk
Mix et al. (2015): Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neckMucositis
Tumor response
PFS (Progression-Free Survival)
OS (Overall Survival)
Quality of life
Toxicity
Grade 3 or 4
Complete response rate (CR)
NA
NA
Measured with EORTC C-30 Version 3 and EORTC QLQ - H&N35
Other treatment-associated side effects such as xerostomia, renal impairment, hearing dysfunction, and myelosuppression
Overall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4)
Only one patient from the intervention arm did not reach CR and died
After 12 months: No significant differences between arms
After 12 months: No significant differences between arms
No significant difference for week 6-8 post-treatment and Follow-up within a year
Overall:
  • Hearing dysfunction n=1 each in the intervention arm and placebo arm;
  • elevated creatinine n=1 in the placebo arm;
  • myelosuppression: anemia in the placebo arm n=1;
  • leukopenia in the intervention arm n=3 and placebo arm n=2;
  • dermatitis in the intervention arm n=2;
  • dry mouth in the placebo arm n=2;
  • dysgeusia in the intervention arm n=2, placebo arm n=1;
  • odyno-/dysphagia in the intervention arm n=1, placebo arm n=2;
  • oral/throat pain in the placebo arm n=2;
  • mucus/sputum intervention arm n=3, placebo arm n=1
some concerns
low risk
low risk
low risk
some concerns
some concerns
Muecke et al. (2010): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncologySelenium level
Toxicity
Performance Status
Quality of life
DFS (Disease-Free Survival)
OS (Overall Survival)
Efficiancy of supplementation
Diarrhea
NA
NA
NA
NA
After 6 weeks post radiotherapy, levels between arms were comparable
Overall incidence of grade 2 diarrhea: intervention arm 20.5% vs. control arm 44.5% (p = 0.04)
No difference between arms
No difference between arms
Median follow-up of 49 months (range, 0-75): 5-year disease free survival in the intervention arm was 80.1% vs. 83.2% in the control arm, no significant difference; p = 0.74
Median follow-up of 51 months (range 6-75): 5-year overall survival in the intervention arm was 91.9% vs. 83.1% in the control arm, no significant difference; p = 0.34
some concerns
some concerns
some concerns
some concerns
some concerns
some concerns
Muecke et al. (2013): Impact of treatment planning target volumen (PTV) size on radiation induced diarrhoea following selenium supplementation in gynecologic radiation oncology-a subgroup analysis of a multicenter, phase III trialToxicityDiarrheaNAsome concerns
Muecke et al. (2014): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology: follow-up analysis of the survival data 6 years after cessation of randomizationDFS (Disease-Free Survival)
OS (Overall Survival)
10-year disease-free survival
10-year overall survival
10-year disease-free survival intervention arm 80.1% vs. control arm 83.2%; not significant; p = 0.65
10-year overall survival intervention arm 55.3% vs. control arm 42.7%; not significant; p = 0.09
high risk
high risk
Stratton et al. (2010): Oral Selenium Supplementation Has No Effect on Prostate- Specific Antigen Velocity in Men Undergoing Active Surveillance for Localized Prostate CancerPSA level (Prostate-Specific Antigen)Change over 5 yearsAfter 5 years: selenium arms not significantly different to placebo arm (p=0.32 and p=0.61) or to each other Subgroup of high-selenium arm with high selenium value at baseline shows higher PSA values than placebo arm (p=0.018)some concerns

Hilft Vitamin C gegen Fatigue?

 Results during interventionResults after interventionOverall RoB judgment
Jeon et al. (2016): Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trialNA
NA
NA
?
Estimated mean (SD) from graphic:

2, 6 and 24h post-op: at rest significantly lower in intervention compared to placebo; p's<0.05 (no values reported, only graphs)

While coughing: no significant difference at any time point; p's>0.05
Morphine use (in mg) at 2h was significantly lower in intervention arm (p<0.05), no significant difference between the two arms at 6h and 24h (p's>0.05).
No difference between groups in postoperative fatigue scores (p's>0.05)
Rescue analgesics were required more frequently in the placebo arm; significant difference compared to intervention arm (p = 0.00).

Frequency as Mean(SD): Intervention: 0.8(0.8)

Placebo: 1.4(1.0)
?
?
?
?

Welche Evidenz gibt es für Vitamin C hochdosiert?

 Outcome nameResults after interventionDosage and regimeOverall RoB judgment
Chung et al. (2016): Randomized Trial of Vitamin C/E Complex for Prevention of Radiation- Induced Xerostomia in Patients with Head and Neck CancerXerostomia
OS (Overall Survival)
DFS (Disease-Free Survival)
T0: before radiotherapy,

T1: 1 month post-radiotherapy, T2: 6 months post-radiotherapy

Xerostomia questionnaire (mean (SD), no group comparison reported) Intervention arm T0: 5.4 (4.3), T1: 8.1 (4.2), T2: 5.4 (4.0) T0-T1: p = 0.02, T1-T2: p = 0.007 Placebo arm T0: 4.6 (3.8), T1: 7.0 (4.5), T2: 7.0 (4.6) T0-T1: p = 0.06 T1-T2: p = 0.97

Xerostomia score (no group comparison reported) Intervention arm T0: 2.8 (2.3), T1: 5.0 (2.8), T2: 3.7 (3.9) T0-T1: p = 0.004, T1-T2: p = 0.008 Placebo arm T0: 1.7 (1.4), T1: 3.9 (2.4), T2: 3.3 (2.3) T0-T1: p = 0.004, T1-T2: p = 0.47

Salivary scintigraphy No group difference for maximum accumulation, or ejection fraction at T1 or T2 (p=0.86, p=0.15; p=0.57, p=0.68), Intervention arm showed better values before (p=0.01) and after stimulation (p=0.009) compared to placebo arm at T1
Overall

No significant differences between arms (p = 0.75)
Overall

No significant differences between arms (p = 0.87)
100 IU vitamin E + 500mg vitamin C, orally, 2x daily, duration: 1 week prior to radiotherapy until 1 month after radiotherapy (average intervention period: 3 months)
Placebo pill, orally, 2x daily, duration: 1 week prior to radiotherapy until 1 month after radiotherapy (average intervention period: 3 months)
?
?
?
Jeon et al. (2016): Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trialPain
Additional medication
Fatigue
Additional medication
Estimated mean (SD) from graphic:

2, 6 and 24h post-op: at rest significantly lower in intervention compared to placebo; p's<0.05 (no values reported, only graphs)

While coughing: no significant difference at any time point; p's>0.05
Morphine use (in mg) at 2h was significantly lower in intervention arm (p<0.05), no significant difference between the two arms at 6h and 24h (p's>0.05).
No difference between groups in postoperative fatigue scores (p's>0.05)
Rescue analgesics were required more frequently in the placebo arm; significant difference compared to intervention arm (p = 0.00).

Frequency as Mean(SD): Intervention: 0.8(0.8)

Placebo: 1.4(1.0)
Intravenous, 30 minutes
50mg/kg (ascorbic acid 10 g/20 mL) mixed with normal saline for a total injection volume of 50 mL; intravenous, 30 minutes
?
?
?
?
Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trialSalivary gland function
Salivary gland function
Salivary gland function
Salivary gland function
No data available
NA
NA
NA
100 mg every 4 h in the daytime over 6 d
100 mg every 4 h in the daytime over 6 d
100 mg every 4 h in the daytime over 6 d
100 mg every 4 h in the daytime over 6 d
?
?
?
?

Welche Nebenwirkungen hat Curcumin?

 Side Effects / Interactions
Hejazi et al. (2013): A pilot clinical trial of radioprotective effects of curcumin supplementation in patients with prostate cancerAccording to information no side effects
According to information no side effect
Hejazi et al. (2016): Effect of Curcumin Supplementation During Radiotherapy on Oxidative Status of Patients with Prostate Cancer: A Double Blinded, Randomized, Placebo-Controlled StudyAccording to information no side effects
According to information no side effect
Mansourian et al. (2015): The effect of "curcuma Longa" topical gel on radiation -induced oral mucositis in patients with head and neck cancerNI
NI
Rao et al. (2014): The Indian Spice Turmeric Delays and Mitigates Radiation-Induced Oral Mucositis in Patients Undergoing Treatment for Head and Neck Cancer: An Investigational StudyNI
NI
Ryan et al. (2013): Curcumin for radiation dermatitis: a randomized, double-blind, placebo-controlled clinical trial of thirty breast cancer patientsAccording to information no side effects.
According to information no side effects.

Hilft Curcumin gegen Übelkeit?

Keine Ergebnisse gefunden.

Verbessert Vitamin D die Osteoporose?

Keine Ergebnisse gefunden.

In welcher Dosis sollte Vitamin D eingenommen werden?

 Dosage and regime
Akiba et al. (2018): Vitamin D Supplementation and Survival of Patients with Non–small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled TrialTwo capsules of vitamin D3 (total 1,200 IU/day), for 12 months
Two capsule form and identical in appearance and taste, containing sesame oil, gelatin derived from swine, and glycerin, for 12 months
Antunac et al. (2018): Vitamin D Supplementation and Survival in Metastatic Colorectal CancerCholecalciferol 2000 IU daily, for 2 years or until death, whichever came first
Only standard chemotherapy
Attia et al. (2008): Randomized, Double-Blinded Phase II Evaluation of Docetaxel with or without Doxercalciferol in Patients with Metastatic, Androgen-Independent Prostate CancerSupplied by Genzyme as 2.5 μg soft gel capsules,10 μg (i.e., four capsules of 2.5 μg) of doxercalciferol orally each day of the chemotherapy cycles before breakfast and at the same time,

Duration: for 1-12 cycles of chemotherapy (each cycle: 28 days), median duration: 6 cycles
10 μg of placebo (equal in weight to, and containing only the inactive ingredients found in, the doxercalciferol capsules), orally each day of the chemotherapy cycles before breakfast and at the same time,

Duration: for 1-12 cycles of chemotherapy (each cycle: 28 days), median duration: 6 cycles
Beer et al. (2007): Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: a report from the ASCENT InvestigatorsDN-101 (45 μg) orally (high concentration formulation of calcitriol), weekly for 3 consecutive weeks of a 4-week cycle
Placebo orally (high concentration formulation of calcitriol), weekly for 3 consecutive weeks of a 4-week cycle
Brown et al. (2019): Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Body Composition among Patients with Advanced or Metastatic Colorectal Cancer: A Randomized TrialA loading dose of 8000 IU/d of vitamin D3 (two 4000 IU capsules) for cycle 1 followed by 4000 IU/d for subsequent cycles
400 IU/d of vitamin D3 during all cycles (one 400 IU capsule plus 1 placebo capsule during cycle 1)
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter TrialVitamin D3 oil drops (color and taste matched) 4000 IU/day, for 12 weeks
Placebo (oil drops), for 12 weeks
Hajimohammadebrahim-Ketabforoush et al. (2019): Effect of Vitamin D Supplementation on Postcraniotomy Pain After Brain Tumor Surgery: A Randomized Clinical TrialIntramuscular injection of 300,000 IU vitamin D 2-14 days (with an average of 5 days) before surgery + all participants: pain medication, including intravenous injection of apotel 1 g, morphine sulfate 3 mg, and oral acet-aminophen 500 mg, depending on each patient’s need in the intensive care unit and ward
All participants: pain medication, including intravenous injection of apotel 1 g, morphine sulfate 3 mg, and oral acet-aminophen 500 mg, depending on each patient’s need in the intensive care unit and ward
Inglis et al. (2020): Effects of High-Dose Vitamin D Supplementation on Phase Angle and Physical Function in Patients with Prostate Cancer on ADT50,000 IU/ week, over 24 weeks


+ all participants: daily multivitamin containing the RDA for vitamin D: 600 IU/day + 210 mg/day calcium and calcium supplements (800 mg/day)
Placebo vitamin D weekly, over 24 weeks


+ all participants: daily multivitamin containing the RDA for vitamin D: 600 IU/day + 210 mg/day calcium and calcium supplements (800 mg/day)
Jacot et al. (2016): Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III studyBaseline vitamin D deficiency level: <10 ng/ml 100 000 IU vitamin D3 on day 1, 15, 28, 43, 58 and at 3 months,

Baseline vitamin D deficiency level: 10-20 ng/ml 100 000 IU vitamin D3 on day 1, 15, 28, 43 and at 3 months,

Baseline vitamin D deficiency level: 20-30 ng/ml 100 000 IU vitamin D3 on day 1, 15 and at 3 months
Daily 400 IU vitamin D3
Johansson et al. (2021): Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled TrialOral solution in ampoule containing 100,000 IU of vitamin D3 (an average of 2000 IU/day), every 50 days, for 3 years
Oral solution in ampoule containing placebo, every 50 days, for 3 years
Keshavarzi et al. (2019): The effect of vitamin D and E vaginal suppositories on tamoxifen-induced vaginal atrophy in women with breast cancerVaginal suppositories containing 2 g of the base substance plus 1000 IU of vitamin D (0.025 mg), every day before bedtime
Vaginal suppositories containing 1 mg of vitamin E plus 2 g of the base substance, every day before bedtime
Vaginal suppositories containing only 2 g of the base substance, every day before bedtime
Khan et al. (2017): Randomized trial of vitamin D3 to prevent worsening of musculoskeletal symptoms in women with breast cancer receiving adjuvant letrozole. The VITAL trialThree capsules of 10,000 IU Vitamin D3 weekly

+ all patients: 1200 mg of calcium plus 600 IU of vitamin D daily (‘‘standard supplementation’’) and Letrozole 2.5 mg PO daily
Three capsules of placebo weekly

+ all patients: 1200 mg of calcium plus 600 IU of vitamin D daily (‘‘standard supplementation’’) and Letrozole 2.5 mg PO daily
Nasser et al. (2017): Vitamin D ointment for prevention of radiation dermatitis in breast cancer patientsCalcipotriol to the lateral side of the breast,

Duration: while radiotherapy treatment
Calcipotriol to the medial side of the breast,

Duration: while radiotherapy treatment
Ng et al. (2019): Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival Among Patients With Advanced or Metastatic Colorectal Cancer: The SUNSHINE Randomized Clinical TrialA loading dose of 8000 IU/d of vitamin D3 (two 4000 IU capsules) for cycle 1 followed by 4000 IU/d for subsequent cycles
400 IU/d of vitamin D3 during all cycles (one 400 IU capsule plus 1 placebo capsule during cycle 1)
Niravath et al. (2019): Randomized controlled trial of high‐dose versus standard‐dose vitamin D3 for prevention of aromatase inhibitor‐induced arthralgia50,000 International Units (IU) oral vitamin D3 per week for 12 weeks followed by 2000 IU daily for 40 weeks

+ all patients: calcium carbonate 600 mg daily
800 IU Vitamin D3 daily for 52 weeks

+ all patients: calcium carbonate 600 mg daily
Raoufinejad et al. (2019): Oral calcitriol in hematopoietic recovery and survival after autologous stem cell transplantation: a randomized clinical trialOral capsules of calcitriol 0.25 μg, three times daily from day 0 to 30
Oral capsules of placebo (identical to the calcitriol for color, shape, size, taste, and smell), three times daily from day 0 to 30
Rastelli et al. (2011): Vitamin D and aromatase inhibitor-induced musculoskeletal symptoms (AIMSS): a phase II, double-blind, placebo-controlled, randomized trialDaily supplementation with 1,000 mg of calcium carbonate and 400 IU of Vitamin D3:

Baseline 25OHD levels between 20 and 29 ng/ml were randomized to receive vitamin D2, one 50,000 IU capsule, orally once a week for a total of eight consecutive weeks, and then once a month for the rest of the study; Baseline 25OHD levels between 10 and 19 ng/ml received Vitamin D2 50,000 IU capsule or a matching placebo orally for 16 consecutive weeks and then once a month for the rest of the study
Baseline 25OHD levels between 20 and 29 ng/ml got a placebo, orally once a week for a total of eight consecutive weeks, and then once a month for the rest of the study;

Baseline 25OHD levels between 10 and 19 ng/ml received a matching placebo orally for 16 consecutive weeks and then once a month for the rest of the study
Scher et al. (2011): Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer21-day dosing cycles with 5-mg oral prednisone twice daily
28-day dosing cycles of 45-μg oral DN-101 on days 1, 8, and 15, continue DN-101 for up to 48 weeks or until unacceptable DN-101 toxicity or experimental agents were initiated
Shapiro et al. (2016): Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS)All participants: 4-week run-in period with 600 IU D3 to allow serum levels to begin to normalize

Usual care dose of 600 IU D3 capsules daily

+ all participants: 1,000 mg calcium carbonate
All participants: 4-week run-in period with 600 IU D3 to allow serum levels to begin to normalize

High-dose of 4,000 IU D3 capsules daily

+ all participants: 1,000 mg calcium carbonate
Urashima et al. (2019): Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical TrialVitamin D3 supplementation, 2000 IU/d, after surgery until the end of the trial
Placebo after surgery until the end of the trial
Walsh et al. (2010): Use of alpha,25-dihydroxyvitamin D3 treatment to stimulate immune infiltration into head and neck squamous cell carcinoma4 μg of 1,25(OH)2 D for each of 3 sequential days, followed by 4 days of no treatment
NA

Für/gegen was ist die Einnahme von Aloe empfehlenswert?

 Outcome name
Heggie et al. (2002): A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissueToxicity
Toxicity
Toxicity
Toxicity
Hoopfer et al. (2015): Three-arm randomized phase III trial: Quality aloe and placebo cream versus powder as skin treatment during breast cancer radiation therapyToxicity
Toxicity
Toxicity
Lissoni et al. (1998): Biotherapy with the Pineal Immunomodulating Hormone Melatonin versus Melatonin plus Aloe vera in Untreatable Advanced Solid NeoplasmsTumor response
Lissoni et al. (2009): A Randomized Study of Chemotherapy versus Biochemotherapy with Chemotherapy plus Aloe arborescens in Patients with Metastatic CancerTumor response
Toxicity
Mansouri et al. (2016): The Effect of Aloe Vera Solution on Chemotherapy-Induced Stomatitis in Clients with Lymphoma and Leukemia: A Randomized Controlled Clinical TrialStomatitis
Pain
Marucci et al. (2017): Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancerToxicity
Pain
Olsen et al. (2001): The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapyToxicity
Puataweepong et. al (2009): The efficacy of oral Aloe vera juice for radiation induced mucositis in head and neck cancer patients: a double-blind placebo-controlled studyMucositis
Mucositis
Mucositis
Sahebjamee et al. (2015): Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical TrialMucositis
Sahebnasagh et al. (2017): Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical TrialToxicity
Mental status/ function
Quality of life
Toxicity
Su et al. (2004): Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasmsMucositis
Mucositis
Mucositis
Quality of life
Williams et al. (1996): Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity

Hilft Aloe bei Mukositis?

 Results after interventionOverall RoB judgment
Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trialNA
No difference between selenium arm (26.92±6.26 days) and placebo arm (25.81±4.33 days); p=0.38
Overall: No difference between the arms; p= 0.35
No difference between the arms; p= 0.69
Overall: No difference between arms for increase in serum creatinine; p=0.31 or increase in aspartate aminotransferase and alanine transaminase: p=0.62
Significant difference in mean serum selenium level between two arms at 14 days after transplantation (8.34 mcg/dL in the selenium arm vs 7.36 mcg/dL in the placebo arm), p=0.018
Overall: Cumulative incidence (grade 1-4) comparable in both selenium arm (83.8%) and placebo arm (81.1%); p=0.76; grade 3-4 mucositis significantly lower in selenium arm (10.8%) compared to placebo arm (35.1%); p=0.013 (grade 4: 2x in placebo arm, 0x in selenium arm)


Mean duration comparable (p=0.048), only duration of objective mucositis from grade 2 to 4 and back was significantly shorter in the selenium arm (3.6±1.84 days) than in the placebo arm (5.3±2.2 days); p=0.014
NA
some concerns
some concerns
some concerns
some concerns
some concerns
some concerns
high risk
some concerns
Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck CancerAt the end of radiation (after 7 weeks) there was no difference in the mean serum selenium level between the selenium arm and placebo arm (p=0.24)

Based on the selenium level before radiation, developing severe oral mucositis was statistically significant postponed in patients who had selenium levels ≥ 65 mcg/L (p=0.04)
After 7 weeks no significant differences between the selenium arm and the placebo arm for:

  • mean duration of oral mucositis (grade 1–4) (p=0.27)
  • onset of oral mucosits (p =0.31)
  • recovery (day after radiation completion (p=0.80)
  • cumulative incidence of oral mucusitis (grade 1–4) (p=0.79)


Severe oral mucositis (grade 3 or 4) was seen in 25 patients in the selenium arm and in 20 patients in the placebo arm.


Addition: Development of oral mucositis in patients with selenium levels >65 mcg/l significantly delayed from baseline (p=0.04, no further explanation given)
NA
high risk
Mix et al. (2015): Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neckOverall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4)
Only one patient from the intervention arm did not reach CR and died
After 12 months: No significant differences between arms
After 12 months: No significant differences between arms
No significant difference for week 6-8 post-treatment and Follow-up within a year
Overall:
  • Hearing dysfunction n=1 each in the intervention arm and placebo arm;
  • elevated creatinine n=1 in the placebo arm;
  • myelosuppression: anemia in the placebo arm n=1;
  • leukopenia in the intervention arm n=3 and placebo arm n=2;
  • dermatitis in the intervention arm n=2;
  • dry mouth in the placebo arm n=2;
  • dysgeusia in the intervention arm n=2, placebo arm n=1;
  • odyno-/dysphagia in the intervention arm n=1, placebo arm n=2;
  • oral/throat pain in the placebo arm n=2;
  • mucus/sputum intervention arm n=3, placebo arm n=1
some concerns
low risk
low risk
low risk
some concerns
some concerns

Schützt Aloe vor Hautentzündungen?

In welcher Dosis sollte man Ingwer bei Übelkeit einsetzen?

 Outcome nameDosage and regime
Ansari et al. (2016): Efficacy of Ginger in Control of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients Receiving Doxorubicin- Based ChemotherapyNausea
Vomiting
Daily dose 2x2 ginger capsules (250mg ginger powder each), every 12h for 3 days over 3 cycles, start not specified
Daily dose 2x2 capsules, every 12h for 3 days over 3 cycles, start not specified
Fahimi et al. (2011): Evaluating the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based RegimensNausea
Vomiting
Four capsules of powdered ginger (Zintoma®, Gol Daru) daily (each capsule contained 250 mg of ginger)
Four capsules of placebo (lactose)
Lua et al. (2015): Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancerNausea
Quality of life
Unspecified effects
Antiemetics + bottle with 2 drops of ginger oil

Glass pendant (in the form of a small flask), to be hung approx. 20 cm from the nose, the bottle was held directly under the nose and inhaled deeply at least 3 times a day for 2 minutes each time

Start: Day 1 of chemotherapy
Worn for 5 days at a time from the day of the chemotherapy, inhaled deeply at least 3 times a day for 3 periods of 2 minutes each

Start: Day 1 of chemotherapy
Panahi et al. (2012): Effect of Ginger on Acute and Delayed Chemotherapy-Induced Nausea and Vomiting: A Pilot, Randomized, Open-Label Clinical TrialNausea and Vomiting
Nausea and Vomiting
Nausea and Vomiting
Daily dose 3x0.5g Every 8h, starting 30min after chemotherapy
Every 8h, starting 30min after Chemotherapy
Ryan et al. (2011): Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patientsNausea
Nausea
Quality of life
Vomiting
250mg 2x3 ginger capsules (liquid extract from ginger root in virgin olive oil + excipients, 1.5g ginger daily)

1.5g daily
2x1 placebo capsules 250mg 2x2 ginger capsules ((liquid extract from ginger root in virgin olive oil + excipients and placebo capsules, 1.0g ginger daily)
2x2 placebo capsules

250mg 2x1 ginger capsules (liquid extract from ginger root in virgin olive oil + excipients and placebo capsules, 0.5g ginger daily)
2x3 placebo capsules
Sontakke et al. (2003): Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized, cross-over, double blind studyNausea
Vomiting
Vomiting
Toxicity
Two capsules, each containing 500 mg of gin- ger powder, orally, 2 ml of normal saline IV, 20 min prior to chemotherapy. Two capsules of ginger were repeated after 6 h of cancer chemotherapy.
2 capsules of lactulose orally and injection metoclopramide 20 mg IV, 20 min prior to chemotherapy. Two capsules of 5 mg metoclopramide each, orally after 6 h
2 capsules of lactulose orally and injection ondansetron 4 mg IV, 20 min prior to chemotherapy and two capsules of ondansetron, 2 mg each, orally after 6 h.
Uthaipaisanwong et al. (2020): Effects of ginger adjunct to the standard prophylaxis on reducing carboplatin and paclitaxel-induced nausea vomiting: a randomized controlled studyNausea
Nausea
Vomiting
Toxicity
Daily dose 4x500mg before meals and one in the evening from day 1 to day 5 of chemotherapy

+ standard antiemetic medication included 20 mg of dexamethasone, 8 mg of ondansetron, and 50 mg of ranitidine which were injected 30 min before chemotherapy administration; if necessary 50mg dimenhydrinate before chemotherapy and 5 days at home
Daily dose before meals and one in the evening from day 1 to day 5 of chemotherapy

+ standard antiemetic medication included 20 mg of dexamethasone, 8 mg of ondansetron, and 50 mg of ranitidine which were injected 30 min before chemotherapy administration; if necessary 50mg dimenhydrinate before chemotherapy and 5 days at home
Zick et al. (2008): Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomitingUnspecified effects
Nausea and Vomiting
Nausea and Vomiting
Toxicity
8 capsules daily
1.0-g ginger dose,

- Each capsule contained 250 mg dry extract of ginger root [10:1 (v/v) extraction solvent (ethanol 50%)/root] standard- ized to 15 mg (5%) of total gingerols - four capsules ginger and four capsules placebo daily
2.0-g ginger dose - Each capsule contained 250 mg dry extract of ginger root [10:1 (v/v) extraction solvent (ethanol 50%)/root] standardized to 15 mg (5%) of total gingerols

- 8 capsuels daily