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- 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 study + (Apparently, patients in the aloe arm had a lower incidence of severe mucositis than patients in the placebo arm. This was statistically significant (53% vs. 87%, p=0.004).)
- Dyer et al. (2013): Is reflexology as effective as aromatherapy massage for symptom relief in an adult outpatient oncology population? + (Arm A: 82% to 91% on the various scales, Arm B = 68% to 86% on the various scales. No significant arm differences)
- Cohen et al. (2018): Favorable Effects of a Ketogenic Diet on Physical Function, Perceived Energy, and Food Cravings in Women with Ovarian or Endometrial Cancer: A Randomized, Controlled Trial + (At 12 weeks significant between-arm differ … At 12 weeks significant between-arm difference in the desire to eat something salty, the KD arm craved salt to a greater extent than the ACS arm; difference remained after adjusting for baseline values and chemotherapy status (p = 0.03, significant); no other significant between-arm differences; no significant within-arm differences from baseline to week 12n-arm differences from baseline to week 12)
- Sun et al. (2016): A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy + (At 12 weeks: Full analysis set: no difference between arms PP analysis: less fatigue/improvement of symptoms in intervention compared to placebo arm (intervention: 41.1%, placebo: 25%; χ² = 5.936; p = 0.015); Overall p = 0.0135)
- Sun et al. (2016): A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy + (At 12 weeks: In full analysis set and PP-analysis significant change from baseline (p < 0.01, no further data shown).)
- Büntzel et al. (2010): Selenium Substitution During Radiotherapy of Solid Tumours - Laboratory Data from Two Observation Studies in Gynaecological and Head and Neck Cancer Patients + (At 6 weeks after irradiation no significant differences; Significant differences in selenium concentrations (serum and blood) at the end of radiotherapy (p<0.0001))
- Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer + (At the end of radiation (after 7 weeks) th … 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)</br></br>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)ho had selenium levels ≥ 65 mcg/L (p=0.04))
- Lichtmann et al. (2018): Results of a Double-Blind, Randomized, Placebo-Controlled Study of Nabiximols Oromucosal Spray as an Adjunctive Therapy in Advanced Cancer Patients with Chronic Uncontrolled Pain + (At week 7 no significant difference for SGIC, PGIC and PSQ.)
- Stauder et al. (1991): Strahlentherapeutische Nebenwirkungen bei Abdominalkrebspatienten und deren Reduktion durch hydrolytische Enzyme + (Average tolerability by doctor: enzyme-arm … Average tolerability by doctor: enzyme-arm: 1.57(0.88); control-arm: 1.38(0.86) </br></br>Average tolerability by patient: enzyme-arm: 1.75(1.13); control-arm: 1.41(0.86)</br></br>Therapy result by doctor: enzyme-arm: 1.94(0.79); control-arm : 1.22(0.54)</br></br>Therapy result by patient: enzyme-arm: 1.89(0.85); control-arm: 1.22(0.54)e-arm: 1.89(0.85); control-arm: 1.22(0.54))
- Hershman et al. (2018): Two-Year Trends of Taxane-Induced Neuropathy in Women Enrolled in a Randomized Trial of Acetyl-L Carnitine + (Baseline to week 104 showed no differences between arms (p>0.05))
- Hershman et al. (2018): Two-Year Trends of Taxane-Induced Neuropathy in Women Enrolled in a Randomized Trial of Acetyl-L Carnitine + (Baseline to week 104 showed no differences between arms (p>0.05))
- Hershman et al. (2018): Two-Year Trends of Taxane-Induced Neuropathy in Women Enrolled in a Randomized Trial of Acetyl-L Carnitine + (Baseline to week 104: Intervention arm sig … Baseline to week 104: Intervention arm sign. Reduction in NTX (more severe neuropathy) compared to placebo arm (mean difference -1.39 points, 95% CI = -2.48, -0.30; p=0.01); particularly strong at week 24 (end of intervention) (-1.68, 95% CI = -3.02, -0.33), week 36 (-1.37, 95% CI = -2.69, -0.04) and week 52 (-1.83, 95% CI = -3.35, -0.32), but no difference at week 104</br></br>At 104 weeks, 39.5% on the ALC arm and 34.4% on the placebo arm reported a five-point (10%) decrease from baseline; in both arms, 104-week NTX scores were statistically significantly different compared with baseline (p<0.001)</br></br>Addition: </br>Predictors: A 5-point reduction on the scale from baseline: Women aged ≥60 had an increased risk of worse neuropathy symptoms compared to those under 60 in year 1 (both arms). In arm A, weight was significantly associated with a 14% increased risk of worsening neuropathy for every 5 kg weight gain in year 1, and a 16% increased risk of worsening neuropathy per 5 kg weight in year 2. No further associations with baseline values were observed.ociations with baseline values were observed.)
- Kirste et al. (2011): Boswellia serrata Acts on Cerebral Edema in Patients Irradiated for Brain Tumors. A Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Trial + (Baseline: average score, placebo: 28 points, intervention: 29 points, After radiotherapy: placebo: 28 points, intervention: 27 points, Follow-up after 4 weeks: placebo: 26 points, intervention: 29 points)
- Kirste et al. (2011): Boswellia serrata Acts on Cerebral Edema in Patients Irradiated for Brain Tumors. A Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Trial + (Baseline: average score, placebo: 55.9 points, intervention: 54.3 points, After radiotherapy: placebo: 56.2 points, intervention: 58.6 points, Follow-up after 4 weeks: placebo: 53.8 points, intervention: 61.3 points)
- Khodabakhshi et al. (2019): Feasibility, Safety, and Beneficial Effects of MCT-Based Ketogenic Diet for Breast Cancer Treatment: A Randomized Controlled Trial Study + (Body weight, BMI, fat (%) significantly lower in intervention arm compared to comparison arm (p<0.001, p<0.001, p=0.03) after 3 months)
- Thamlikitkul et al. (2017): Efficacy of ginger for prophylaxis of chemotherapy-induced nausea and vomiting in breast cancer patients receiving adriamycin–cyclophosphamide regimen: a randomized, double-blind, placebo-controlled, crossover study + (Chemotherapy intervention vs. placebo: Dose reduction: 3% vs. 3% Delay: 9% vs. 6% No p-values have been reported.)
- 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 5597 + (Collected in 865 patients in intervention … Collected in 865 patients in intervention arm and 477 in placebo arm: </br>* Grade 1-2 toxicity in intervention arm: 31% and placebo arm: 26% of subjects</br>* Grade ≥ 3 toxicity occurred in less than 2% of subjects in intervention arm and 3% in placebo arm</br>* n=1 patient in placebo arm had constitutional lethal toxicity</br>* no arm comparison performedhal toxicity * no arm comparison performed)
- Sontakke et al. (2003): Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized, cross-over, double blind study + (Complete control ginger-arm vs. placebo-me … Complete control ginger-arm vs. placebo-metoclopramide-arm vs. placebo-ondansetron-arm: 68% vs. 64% vs. 86%</br>placebo-ondansetron-arm significantly higher (p<0.01), no significant difference between ginger-arm and placebo-metoclopramide-arm</br>Partial control ginger-arm vs. placebo-metoclopramide-arm vs. placebo-ondansetron-arm: 26% vs. 34% vs. 14%</br>No control ginger-arm vs. placebo-metoclopramide-arm vs. placebo-ondansetron-arm: 6% vs. 2% vs. 0%</br>Frequency 0-12h after chemotherapy ginger-arm vs. placebo-metoclopramide-arm vs. placebo-ondansetron-arm: 10 vs. 9 vs. 3</br>12-24h after chemotherapy ginger-arm vs. placebo-metoclopramide-arm vs. placebo-ondansetron-arm: 20 vs. 19 vs. 6</br>In all three arms, the frequency of vomiting was significantly higher after 12-24h than after 0-12h (p<0.05)higher after 12-24h than after 0-12h (p<0.05))
- Sontakke et al. (2003): Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized, cross-over, double blind study + (Complete control ginger-arm vs. placebo-me … Complete control ginger-arm vs. placebo-metoclopramide-arm vs. placebo-ondansetron-arm: 62% vs. 58% vs. 86% </br>placebo-ondansetron-arm significantly higher (p<0.01), no significant difference between ginger-arm and placebo-metoclopramide-arm</br>Partial control ginger-arm vs. placebo-metoclopramide-arm vs. placebo-ondansetron-arm: 20% vs. 20% vs. 8%</br>No control ginger-arm vs. placebo-metoclopramide-arm vs. placebo-ondansetron-arm: 18% vs. 22% vs. 6%. placebo-ondansetron-arm: 18% vs. 22% vs. 6%)
- Kessels et al. (2017): Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma A Randomized Clinical Trial + (Complete histological tumor clearance was … Complete histological tumor clearance was observed in 1 of 21 (5%) and 2 of 21 (10%) patients in the sinecatechins and placebo group, respectively no significant difference in histological tumor clearance between the sinecatechins and placebo groups (p > .99).inecatechins and placebo groups (p > .99).)
- Bairati et al. (2005): A Randomized Trial of Antioxidant Vitamins to Prevent Second Primary Cancers in Head and Neck Cancer Patients + (DFS for '''any supplementation''' beyond 3 … DFS for '''any supplementation''' beyond 3.5 years after randomization:</br>HR = 0.85 (95% CI: 0.48, 1.50), i.e. no significant difference between intervention and placebo arm</br></br>DFS for '''beta-carotene + Vit. E''' beyond 3.5 years after randomization: </br>HR = 1.11 (95% CI: 0.47, 2.61), i.e. no significant difference between intervention and placebo arm</br></br>DFS for '''only Vit. E''' beyond 3.5 years after randomization: </br>HR = 0.71 (95% CI: 0.33, 1.53), i.e. no significant difference between intervention and placebo armrence between intervention and placebo arm)
- Barton et al. (1998): Prospective evaluation of vitamin E for hot flashes in breast cancer survivors + (Decrease Baseline to 4 weeks in % Frequen … Decrease Baseline to 4 weeks in %</br></br>Frequency of hot flashes per day:</br>Intervention arm: 25%, Placebo arm: 22%; p = 0.90 ns.</br>Correlation with baseline value: r = 0.12; p = 0.21 ns.</br></br>Daily hot flash score (frequency with average severity):</br>Intervention arm: 28%, Placebo arm: 20%; p = 0.68 ns.</br>Correlation with baseline value: r = 0.13; p = 0.18 ns.</br></br>--------------</br>Crossover: Decrease 4 weeks to 8 weeks in %</br>Frequency of hot flashes per day:</br>Intervention arm: 0.04%, Placebo arm: 17%; p = 0.32 ns.</br></br>Daily hot flash score:</br>Intervention arm: 0.03%, Placebo arm: 25%; p = 0.24 ns.</br>Within-subject analysis: Significant differences in frequency and hot flash score between placebo and Vit. E (both p ≤ 0.05), approximately 1 less hot flash</br></br>Frequency differences between placebo and Vitamin E per week:</br>Intervention arm (Vitamin E first then Placebo): Week 1 vs. 5: p = 0.01; Week 2-4 vs. Week 6-9: p < 0.05, sign.</br>Placebo arm (Placebo first then Vitamin E): Week 1 vs. 5: p = 0.001; Week 2 vs. 6: p = 0.0004; Week 3 vs. 7: 0.003; Week 4 vs. 8: p = 0.07, sign.</br>Similar results for hot flash score</br></br>Question about patient preference in both arms:</br>Vit. E: 32%, Placebo: 29%, No preference: 38%.it. E: 32%, Placebo: 29%, No preference: 38%.)
- Henning et al. (2015): Randomized Clinical Trial of Brewed Green and Black Tea in Men With Prostate Cancer Prior to Prostatectomy + (Decrease in serum PSA levels higher in the … Decrease in serum PSA levels higher in the green tea arm compared to the water arm (p=0.04)</br>PSA mean (SD) per arm</br>Green tea arm (N=30): baseline= 9.6(5.2); after 33 days= 8.4(4.3)</br>Water arm (N=30): baseline= 9.9(8.5); after 29 dayse= 10.0(9.0)</br></br>No significant difference in changes between black tea arm and water arm (p>0.05)tween black tea arm and water arm (p>0.05))
- Kessels et al. (2017): Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma A Randomized Clinical Trial + (Decrease in tumor size was slightly greater after sinecatechins application, but the difference was nonsignificant (p = 0.15).)
- Henning et al. (2015): Randomized Clinical Trial of Brewed Green and Black Tea in Men With Prostate Cancer Prior to Prostatectomy + (Detection of tea polyphenols in prostate t … Detection of tea polyphenols in prostate tissue in 32 of 34 men in the green tea arm , but not in the other arms.</br>Detection of EGC, EC and methyl-EGC in early morning urine throughout the study in the green tea arm and at significantly lower concentrations in the black tea arm (p<0.01); no polyphenols in the water arm.(p<0.01); no polyphenols in the water arm.)
- Wrbka et al. (1987): Unterstützung der Chemotherapie inoperabler Karzinome durch proteolytische Fermente + (Enzyme-arm: 68% improvement compared to control-arm: 57.69% improvement)
- Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers + (Enzyme-arm: no evaluation N=3, complete/go … Enzyme-arm: no evaluation N=3, complete/good response in N=32/16, moderate response N=1, poor/no response/progress N=1 </br></br>Control-arm: no evaluation N=4, complete/good response N=23/15, moderate response N=5, poor/no response/progress N=0, </br></br>but arm difference is not statistically significant (p=0.23) is not statistically significant (p=0.23))
- Jeon et al. (2016): Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial + (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)
- Zick et al. (2008): Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting + (Examiners could not guess allocation (p=0. … Examiners could not guess allocation (p=0.27), patients could guess allocation significantly correctly (p=0.01)</br>Reasons given: Taste: placebo: 33%; 1.0g ginger: 25%, 2.0g ginger: 9%; p=0.01</br>Effect of the capsule: placebo: 33%, 1.0g ginger: 51%, 2.0g ginger: 16%; p=0.121.0g ginger: 51%, 2.0g ginger: 16%; p=0.12)
- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (Exploratory analysis: After 4 weeks (end o … Exploratory analysis:</br>After 4 weeks (end of phase II, PMA Analysis): significant difference for the functional subscale (b=1.9; p=0.03; unadjusted; b=2.0; p=0.002; adjusted); Intervention arm: Baseline: Mean (SD) = 11.4 (5.1) – 4 weeks: Mean (SD) = 11.0 (3.2), Placebo arm: Baseline: Mean (SD) = 10.8 (6.0) – 4 weeks: Mean (SD) = 9.2 (3.8); this difference is due to the decrease in values in the placebo arm; no direct comparison was conductedbo arm; no direct comparison was conducted)
- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (Exploratory analysis: After 4 weeks (end o … Exploratory analysis:</br>After 4 weeks (end of phase II; PMA, pattern mixture analysis): greater change for the intervention arm compared to the placebo arm (b=2.6; p=0.03; adjusted), Intervention arm: Baseline: Mean (SD) = 16.0 (8.5) – 4 weeks: Mean (SD) = 22.4 (10.7), Placebo arm: Baseline: Mean (SD) = 11.8 (6.1) – 4 weeks: Mean (SD) = 15.1 (4.8).8 (6.1) – 4 weeks: Mean (SD) = 15.1 (4.8))
- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (Exploratory analysis: After 4 weeks (end o … Exploratory analysis:</br>After 4 weeks (end of phase II, PMA Analysis): significant difference between the arms (b=2.58; p=0.003, unadjusted; b=2.7; p=0.002, adjusted), Intervention arm: Baseline: Mean (SD) = 58.2 (8.8) – 4 weeks: Mean (SD) = 64.2 (9.0), Placebo arm: Baseline: Mean (SD) = 57.0 (4.8) – 4 weeks: Mean (SD) = 50.0 (15.5); with higher values for the intervention arm and lower values for the placebo armn arm and lower values for the placebo arm)
- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (Exploratory analysis: No differences between arms and/or time points for PMA-Analysis)
- Campos et al. (2011): Guarana (Paullinia cupana) Improves Fatigue in Breast Cancer Patients Undergoing Systemic Chemotherapy + (FACIT-F: Significantly lower severity of f … FACIT-F: Significantly lower severity of fatigue with guarana compared to placebo, </br>Significantly more patients with improved FACIT-F global scores on guarana at days 21 (52% versus 10%) and at day 49 (66% versus 13%) as compared with patients who received placebo.</br>After day 1: p = 0.09</br>After day 21: p = < 0.01</br>After day 49: p = < 0.01 </br></br>FACIT-ES: Significantly lower expression of endocrine symptoms with guarana compared to placebo</br>In the intragroup analysis, there were significant differences favoring guarana for the placebo–guarana arm but not for the guarana–placebo arm.</br>After day 1: p = 0.18 </br>After day 21: p = 0.01 </br>After day 49: p = < 0.01After day 21: p = 0.01 After day 49: p = < 0.01)
- Dos Santos Martins (2016): Placebo-Controlled, Double-Blind, Randomized Study of a Dry Guarana Extract in Patients with Head and Neck Tumors Undergoing Chemoradiotherapy: Effects on Fatigue and Quality of Life + (FACT-HN35: After first round of chemoradio … FACT-HN35:</br>After first round of chemoradiotherapy: significant improvement in guarana group for domains pain (p = 0.0133), social eating (p = 0.0227), swallowing (p = 0.0254), coughing (p = 0.0107), and weight loss (p = 0.012)</br>After the fourth round of chemoradiotherapy: significantly worse in domain weight loss (p = 0.0074) and greater use of a nasogastric tube (p = 0.051), in addition to increased use of analgesics (p = 0.0253) in guarana group</br></br></br>FACT Questionnaire: </br>Comparison between intervention and placebo arm: trend toward worsening in the overall domain: p = .0054, significant worsening in the functional: p = .018 and symptoms domain: p = .0042 after the second cycle of chemotherapy; no significant differences, in any QOL domains, either for the guarana or placebo group, when the first measures were compared to the last assessments of each domain for each particular group</br></br></br>EORTC-QOL C30:</br>No improvement in symptoms in the three domains (functional, overall, and symptoms) in the guarana group compared to the placebo group</br></br></br>No further information or statistical values given, domain specific results of the EORTC questionnaire only displayed in a graphic questionnaire only displayed in a graphic)
- Heggie et al. (2002): A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue + (For the subjects the cumulative probabilit … For the subjects the cumulative probability of grade 2 or more pain was greater in the aloe vera arm than in the placebo arm (26% vs. 17%) (p = 0.03).</br></br>For subjects who had drainage, those in the aloe vera arm had a significantly greater incidence of grade 2</br>or more pain compared with those in the placebo arm (40% vs. 20%) (p = 0.01).</br></br>For subjects who received chemotherapy, there was no difference in pain levels between the two treatment arms.</br></br>For subjects, who did not have chemotherapy, those in the aloe vera arm had a significantly greater incidence of grade 2 or more pain compared with those in the placebo arm (26% vs. 12%) (p = 0.02). the placebo arm (26% vs. 12%) (p = 0.02).)
- Emami et al. (2014): Double-blinded, randomized, placebo-controlled study to evaluate the effectiveness of green tea in preventing acute gastrointestinal complications due to radiotherapy + (Friedman analysis indicated that there was no significant increase in vomiting in both arms during irradiation period.)
- Sun et al. (2016): A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy + (Full analysis set: Significant differences … Full analysis set:</br>Significant differences between arms at all time points with more improvement in intervention arm:</br>12 weeks (4 weeks after intervention): Intervention: 57.8%, Placebo: 39.7%; χ² = 7.406; p = 0.007</br>But no difference of ≥1 grade between arms. </br></br>As well as an overall significantly steeper improvement in intervention arm (p < 0.05) compared to placebo armion arm (p < 0.05) compared to placebo arm)
- Li et al. (2018): Efficacy of Ginger in Ameliorating Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Among Patients With Lung Cancer Receiving Cisplatin-Based Regimens: A Randomized Controlled Trial + (Ginger vs. placebo, mean (SD): 72.79 (14.00) vs. 72.45 (13.93), p=0.884, no significant group difference)
- Campos et al. (2011): Guarana (Paullinia cupana) Improves Fatigue in Breast Cancer Patients Undergoing Systemic Chemotherapy + (Global Chalder Fatigue Scale: Significant … Global Chalder Fatigue Scale: Significant differences favoring guarana, with a drop of -4.6 points in the global score versus a significant increase of + 2.2 points for the arm receiving placebo on day 21, Difference was not significant for the intergroup analysis on day 49. </br>Guarana significantly improved the Global Chalder Fatigue Scale scores throughout the treatment in the placebo–guarana arm and there was a positive trend in the guarana–placebo arm (p=0.06)</br>After day 1: p = < 0.01 </br>After day 21: p = < 0.01 </br>After day 49: p = 0.27 </br></br>BFI: Significantly lower severity of fatigue with guarana compared to placebo.</br>After day 1: p = NI</br>After day 21: p = < 0.01 </br>After day 49: p = < 0.01ter day 21: p = < 0.01 After day 49: p = < 0.01)
- Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial + (ITT: intervention arm n=43 (28%; 95% CI: 0 … 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</br></br>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</br></br>No influence of age, gender, nicotine consumption, stage, selenium concentration at baseline and hospitalium concentration at baseline and hospital)
- Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers + (In both arms a comparable rate of complete and partial remissions was observed, but the proportion of patients with complete regression was slightly higher in the enzyme-arm.)
- Konmun et al. (2017): A phase II randomized double-blind placebo-controlled study of 6-gingerol as an anti-emetic in solid tumor patients receiving moderately to highly emetogenic chemotherapy + (In intervention arm significantly lower change in appetite score than in placebo arm for day 22, 43, 64, adjusted with baseline values from day 1: r -1.65, 95% CI -2.64 to -0.67; p=0.001)
- Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers + (In none of the patients of the enzyme-arm … In none of the patients of the enzyme-arm were skin reactions of grade 4. The difference between the two arms was statistically significant (p<0.0001): Enzyme-arm: 1.23(0.75); control-arm: 2.39(1.10) </br></br>Numbers of patients per grade: </br></br>Enzyme-arm: Grade 1 = 8; Grade 2 = 27; Grade 3 = 16; Grade 4 = 2</br></br>Control-arm: Grade 1 = 0; Grade 2 = 11; Grade 3 = 17; Grade 4 = 11= 0; Grade 2 = 11; Grade 3 = 17; Grade 4 = 11)
- Wrbka et al. (1987): Unterstützung der Chemotherapie inoperabler Karzinome durch proteolytische Fermente + (In patients with survival > 6 months, more patients with better quality of life in enzyme-arm (n=8) compared to control-arm (n=8): (Class I, II enzyme-arm: 81.9% vs. control-arm: 73.3%); similar quality of life in patients with < 6 months survival)
- Vinzenz et al. (1992): Die Therapie der radiogenen Mukositis mit Enzymen + (In the enzyme arm mucositis occurred in 17 … In the enzyme arm mucositis occurred in 17 patients (89.5%) in a period of 5 to 12 days (stage I or II) and in 2 patients (10.5%) between the 19th and 21st day of irradiation (stage III). The mucositis developed on average 9.1 (4.9) days after the start of radiotherapy.</br></br>In the control arm mucositis occurred over a period of 6 to 21 days after the start of radiotherapy with grade III occurring relatively early from the 12th day after the start of radiotherapy. The mucositis developed on average 13.0 (4.1) days after the start of radiotherapy.4.1) days after the start of radiotherapy.)
- 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 5597 + (Interim analysis October 2009: N=83 second … Interim analysis October 2009:</br>N=83 secondary lung tumors; Rate intervention arm: 1.91 per 100 persons per year vs. 1.36 in placebo arm; p=ns</br></br></br>June 2011:</br>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</br></br></br>5-year DFS:</br>October 2009:</br>Intervention arm: 72% vs. placebo arm: 78%, no significance values given</br></br></br>June 2011:</br>Intervention arm: 74.4% vs. placebo arm: 79.6%; p=0.69</br></br></br>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%) and 72.9% (SE, 4.5%) vs. 80.9% (SE, 5.2%))
- 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 5597 + (Intervention arm: 76.8% (SE, 1.6%) vs. pla … Intervention arm: 76.8% (SE, 1.6%) vs. placebo arm: 79.9% (SE, 2.1%); p=0.154</br></br></br>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(SE, 3.6%); no difference for DFS; p=0.245)
- Zick et al. (2008): Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting + (Laboratory abnormalities were close to bei … Laboratory abnormalities were close to being significantly higher in the placebo and 1.0-g dose (8 of placebo vs. 8 of 1.0-g dose vs. 1 of 2.0-g dose; p=0.06) compared to the 2.0-g dose</br></br>2.0g ginger: significantly more fatigue (p=0.03) and other side effects (p=0.02) than in placebo arm, </br>1.0g ginger: no significant difference in terms of overall side effects, non-serious and serious side effects, dyspnea, gastrointestinal events or laboratory abnormalitiesestinal events or laboratory abnormalities)
- Bairati et al. (2005): Randomized Trial of Antioxidant Vitamins to Prevent Acute Adverse Effects of Radiation Therapy in Head and Neck Cancer Patients + (Local recurrence for '''any supplementatio … Local recurrence for '''any supplementation'''</br>HR = 1.37 (95% CI: 0.93, 2.02),i.e. no significant difference between intervention and placebo arm</br></br>Local recurrence for '''beta-carotene + Vit. E'''</br>HR = 1.56 (95% CI: 0.79, 3.07), i.e. no significant difference between intervention and placebo arm </br></br>Local recurrence for '''only Vit. E'''</br>HR = 1.29 (95% CI: 0.89, 2.08), i.e. no significant difference between intervention and placebo armrence between intervention and placebo arm)
- Mondal et al. (2014): Comparative study among glutamine, acetyl-L-carnitine, vitamin-E and methylcobalamine for treatment of paclitaxel-induced peripheral neuropathy + (Mean (95% CI, 6 months after chemotherapy) … Mean (95% CI, 6 months after chemotherapy)</br></br>Sensory</br>Vitamin E: 1.72 (1.35, 2.10),</br>Vitamin B12: 1.60 (1.09, 2.11),</br>Carnitine: 0.65 (0.30, 1.00),</br>Glutamine: 0.58 (0.21, 0.95)</br>F-Wert (ANOVA, including values from after 3 chemotherapy cycles and after 6 chemotherapy cycles) = 1.824; p = 0.115, ns. </br></br>Post-Hoc Analysis: </br>Vitamin E vs. Vitamin B12: p = 0.446</br>Vitamin E vs. Carnitine: p < 0.001, sign. </br>Vitamin E vs. Glutamine: p = 0.002, sign. </br>No difference between Vit. E and Vit. B12, but Vit. E better progression than glutamine and ALC</br></br>Motor</br>Vitamin E: 1.39 (1.09, 1.69),</br>Vitamin B12: 1.40 (1.08, 1.72),</br>Carnitine: 0.20 (0.01, 0.39),</br>Glutamine: 0.32 (0.09, 0.55),</br>F(ANOVA, including values from after 3 chemotherapy cycles and after 6 chemotherapy cycles) = 2.267; p = 0.045, sign. </br></br>Post-Hoc Analysis: </br>Vitamin E vs. Vitamin B12: p = 0.227, ns. </br>Vitamin E vs. Carnitine: p < 0.001, sign. </br>Vitamin E vs. Glutamine: p < 0.001, sign. </br>No difference between Vit. E and Vit. B12, but Vit. E better progression than glutamine and ALC</br></br>Pain</br>Vitamin E: 1.33 (0.95, 1.71),</br>Vitamin B12: 1.30 (0.99, 1.61),</br>Carnitine: 0.10 (-0.04, 0.24),</br>Glutamine: 0.26 (0.05, 0.48),</br>F (ANOVA, including values from after 3 chemotherapy cycles and after 6 chemotherapy cycles)= 3.358; p = 0.004, sign. </br></br>Post-Hoc-Analysis: </br>Vitamin E vs. Vitamin B12: ns.; p = NI </br>Vitamin E vs. Carnitine: p < 0.001, sign. </br>Vitamin E vs. Glutamine: p < 0.001, sign. </br>No difference between Vit. E and Vit. B12, but Vit. E better progression than glutamine and ALCB12, but Vit. E better progression than glutamine and ALC)