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- 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 cancer + (61 patients (58.6%) developed peak grade 3 … 61 patients (58.6%) developed peak grade 3 objective mucositis during treatment, with no difference between arms (p=0.665).</br></br>57 patients (54.8%) developed peak grade 3 functional mucositis during treatment with no differences between arms (p=0.442).</br></br></br>67 patients (64.4%) developed peak grade 3 dysphagia during treatment, with no differences between arms (p = 0.132).h no differences between arms (p = 0.132).)
- Halyard et al. (2007): Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4) + (?)
- Lin et al. (2006): Zinc supplementation to improve mucositis and dermatitis in patients after radiotherapy for head-and-neck cancers: a double-blind, randomized study + (?)
- 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 neck + (After 12 months: No significant differences between arms)
- 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 neck + (After 12 months: No significant differences between arms)
- Chan et al. (2011): Nutritional supplements, COX-2 and IGF-1 expression in men on active surveillance for prostate cancer + (After 12 weeks mean difference: lycopene: 0.53 ng/ml, fish oil: 0.20 ng/ml, placebo: -0.46 ng/ml; p(lycopene vs. placebo)= 0.26, not significant; p(fish oil vs. placebo) = 0.39, not significant)
- Stratton et al. (2010): Oral Selenium Supplementation Has No Effect on Prostate- Specific Antigen Velocity in Men Undergoing Active Surveillance for Localized Prostate Cancer + (After 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))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 39.1 (12.1), pentoxyfillin + placebo: 32.4 (20.8), vitamin E + placebo: 37.1 (15.5); placebos: 32.9 (18.5))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 73.0 (7.2), pentoxyfillin + placebo: 48.6 (35.9), vitamin E + placebo: 52.8 (29.4); placebos: 50.8 (23.9))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 60.2 (10.7), pentoxyfillin + placebo: 39.1 (37.4), vitamin E + placebo: 40.0 (32.0); placebos: 42.6 (17.4) ANOVA: ns., trend of a signif. interaction with vitamin E)
- Upadhyaya et al. (2017): Radioprotective effect of vitamin E on salivary glands after radioiodine therapy for differential thyroid cancer: A randomized-controlled trial + (After 6 months: Vitamin E 100mg: Increas … After 6 months: </br></br>Vitamin E 100mg: Increase EF right parotis (p < 0.01) and UI right submand. (p < 0.05)</br>Vitamin E 200mg: Increase UI right parotis, both Submand. (p < 0.01)</br>Vitamin E 300mg: Increase UF left parotis (p < 0.05) and right submand. (p < 0.01), increase UI in both submand. (p < 0.01)</br>Usual Care: Decreasel UF in both parotis (p < 0.01) </br>Rest: ns.</br></br>All arms compared:</br>UF: left submand.: p < 0.05</br>UI: right parotis: p < 0.05; both submand.: p < 0.01</br>ER: left parotis: p < 0.05otis: p < 0.05; both submand.: p < 0.01 ER: left parotis: p < 0.05)
- Vitale et al. (2020): ZeOxaNMulti Trial: A Randomized, Double-Blinded, Placebo-Controlled Trial of Oral PMA-Zeolite to Prevent Chemotherapy-Induced Side Effects, in Particular, Peripheral Neuropathy + (After 6 months: Intervention n=42, Placebo … After 6 months: Intervention n=42, Placebo n=34, >8 cycles):</br>Placebo had 70.6% and Intervention had 64.3% chemotherapy-induced peripheral neuropathy (not significant, p = 0.56)</br>Secondary analysis showed lower chemotherapy-induced peripheral neuropathy in men in Intervention-arm compared to Placebo-Arm based on 39 patients (p = 0.047, adjusted for age, comorbidity, cycles).</br></br>Intervention-arm was able to complete more cycles of chemotherapy than Placebo-arm (>8 cycles: 71.7% vs. 56.7%, p = 0.03).</br>No difference in the severity of hematologic toxicity (p = 0.09); due to low overall toxicity, no further analyses were conducted.ll toxicity, no further analyses were conducted.)
- Muecke et al. (2010): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology + (After 6 weeks post radiotherapy, levels between arms were comparable)
- Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer + (After 7 weeks no significant differences b … After 7 weeks no significant differences between the selenium arm and the placebo arm for:</br>* mean duration of oral mucositis (grade 1–4) (p=0.27)</br>* onset of oral mucosits (p =0.31)</br>* recovery (day after radiation completion (p=0.80)</br>* cumulative incidence of oral mucusitis (grade 1–4) (p=0.79)</br></br></br>Severe oral mucositis (grade 3 or 4) was seen in 25 patients in the selenium arm and in 20 patients in the placebo arm.</br></br></br>Addition: Development of oral mucositis in patients with selenium levels >65 mcg/l significantly delayed from baseline (p=0.04, no further explanation given)seline (p=0.04, no further explanation given))
- Lian et al. (2014): Comparing the Effectiveness of Green Tea versus Topical Metronidazole Powder in Malodorous Control of Fungating Malignant Wounds in a Controlled Randomised Study + (All patients in both arms had shown reduction in malodorous score over 7 days of treatment. There was no significant difference in the improvement of odour in either arms (p>0.05).)
- Lian et al. (2014): Comparing the Effectiveness of Green Tea versus Topical Metronidazole Powder in Malodorous Control of Fungating Malignant Wounds in a Controlled Randomised Study + (All patients reported an improvement in od … All patients reported an improvement in odour control after day 7 (p=0.00), impairment of daily life (p=0.00), physical discomfort (p=0.00), appetite (p=0.00) and social activities (p=0.00); but there are no significant differences between the two arms (p>0.05), except for Q5. The green tea arm rated that the odour from their wounds had significantly impacted (p=0.04) their social activities prior to treatment.) their social activities prior to treatment.)
- Dale et al. (2001): Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects + (Although the maximum extent of gastrointes … Although the maximum extent of gastrointestinal side effects was reduced in the enzyme-arm, the difference to the control-arm was not statistically significant (p=0.12). The treatment effect was observed from 1 week after start of radiation therapy until the last follow-up visit 5 month after intervention.ollow-up visit 5 month after intervention.)
- 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)