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- Salehi et al. (2015): Effect of Vitamin E on Oxaliplatin-induced Peripheral neuropathy Prevention: A Randomized Controlled Trial + (Overall: Number in % Intervention: 100, Control: 96; p = 0.8 Mittelwert (SD): Intervention: 6.37 (2.85), Control: 6.57 (2.94); p = 0.78 No significant group differences were found when considering gender and age (no numbers reported).)
- Mazdak et al. (2012): Vitamin E reduces superficial bladder cancer recurrence: A randomized controlled Trial + (Overall: Number in % intervention arm: 1 … Overall: </br></br>Number in %</br>intervention arm: 19, control arm: 36; RR = 0.53 (95% CI 0.19 – 0.92); OR = 0.42 (95% CI: 0.19, 0.92); p = 0.04, sign.</br></br>Recurrences in the first year: </br>intervention arm: 66.7% of recurrences, control arm: 75% of recurrences</br></br>Time to recurrence in months (mean (SD)): </br>intervention arm: 9 (8.1), control arm: 8.33 (6.1); p = 0.9, not sign. </br></br>Separated by smoking status:</br>Smokers: intervention arm: 25%; control arm: 50%; p = 0.06</br>Non-smoker: intervention arm: 15.4%; control arm: 26.7%; p = 0.15n arm: 15.4%; control arm: 26.7%; p = 0.15)
- Kottschade et al. (2011): The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase 3 clinical trial + (Overall: Numer in percentage (95% CI) in … Overall: </br></br>Numer in percentage (95% CI)</br>intervention arm: 34 (25.0, 44.8)</br>placebo arm: 29 (20.1, 39.4); p = 0.43, ns.</br></br>No significant differences were found in subgroup analyses by gender, age, number of chemotherapy cycles, and types of chemotherapy (p > 0.05 for each).</br></br>No significant differences in self-reported issues from neuropathic symptoms such as numbness, tingling, etc. (p = 0.11-0.88). as numbness, tingling, etc. (p = 0.11-0.88).)
- 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 + (Overall: * Hearing dysfunction n=1 each i … Overall: </br>* Hearing dysfunction n=1 each in the intervention arm and placebo arm; </br></br>* elevated creatinine n=1 in the placebo arm; </br></br>* myelosuppression: anemia in the placebo arm n=1; </br></br>* leukopenia in the intervention arm n=3 and placebo arm n=2; </br></br>* dermatitis in the intervention arm n=2; </br></br>* dry mouth in the placebo arm n=2; </br></br>* dysgeusia in the intervention arm n=2, placebo arm n=1; </br></br>* odyno-/dysphagia in the intervention arm n=1, placebo arm n=2; </br></br>* oral/throat pain in the placebo arm n=2; </br></br>* mucus/sputum intervention arm n=3, placebo arm n=1utum intervention arm n=3, placebo arm n=1)
- Shokri et al. (2017): Comparison of the Complications of Platinum-Based Adjuvant Chemotherapy With and Without Ginger in a Pilot Study on Ovarian Cancer Patients + (Overall: Nausea / vomiting: intervention- … Overall: </br>Nausea / vomiting: intervention-arm: 8, placebo-arm: 14 participants (p=0.57) </br></br>Weight loss: intervention-arm: 1, placebo-arm: 1 participant (p=0.66)</br></br>Peripheral neuropathy: intervention-arm: 3, placebo-arm: 5 participants (p=0.58)</br></br>Bone marrow depression: intervention-arm: 2, placebo-arm: 2 participants (p=0.54)</br></br>Temporary cortical blindness: intervention-arm: 1, placebo-arm: 0 participants (p=0.41) </br></br>Other side effects: intervention-arm: 10, placebo-arm: 21 participants (p= 0.11) </br></br>No significant differences between arms No significant differences between arms)
- Dias et al. (2015): The chemopreventive effect of Ginkgo biloba extract 761 against cisplatin ototoxicity: a pilot study + (Overall: Significantly lower DPOAEs in placebo arm compared to ginkgo arm at a frequency of 8KHz, p=0.03 Significantly lower SNRs in placebo arm compared to Ginkgo arm at a frequency of 8KHz, p=0.04)
- Howells et al. (2011): Phase I randomised double-blind pilot study of micronized resveratrol (SRT501) in patients with hepatic metastases - safety, pharmacokinetics and pharmacodynamics + (Overall: There was no difference between … Overall: </br>There was no difference between patients who received placebo or SRT501 in terms of plasma/serum levels of prostaglandin E2 (PGE-2) and vascular endothelial growth factor (VEGF). The analysed tissue samples show no significant differences between placebo and SRT501. Apoptosis, as reflected by immunohistochemistry for cleaved caspase 3 in tumor tissue, was significantly increased by 39% (to 1.44% total apoptotic cells, p=0.038) in patients on SRT501 compared to those taking placebo.n SRT501 compared to those taking placebo.)
- Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial + (Overall: Cumulative incidence (grade 1-4) … 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)</br></br></br>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=0.014in the placebo arm (5.3±2.2 days); p=0.014)
- Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial + (Overall: No difference between arms for increase in serum creatinine; p=0.31 or increase in aspartate aminotransferase and alanine transaminase: p=0.62)
- Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial + (Overall: No difference between the arms; p= 0.35)
- 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 + (Overall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4))
- Afonseca et al. (2013): Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: A pilot randomized clinical trial + (Overall: number of grade 1-2 intervention arm: 83%, placebo arm 68%; p = 0.45)
- Hejazi et al. (2016): Effect of Curcumin Supplementation During Radiotherapy on Oxidative Status of Patients with Prostate Cancer: A Double Blinded, Randomized, Placebo-Controlled Study + (PSA level (ng/ml) within 3 months: * Mean change (SD): Intervention arm 0.12 ( 0.16), placebo arm: 0.13 (0.06); p = 0.78 * No information on PFS within one year)
- Nguyen et al. (2012): Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities + (PSA values showed a greater decrease for t … PSA values showed a greater decrease for those on polyphenon E than those on placebo but this did not reach statistical significance (p=0.26). Reduction of PSA in Polyphenon E arm = 14 (58.3), in Placbo arm = 8 (36.4), but no significant group difference (p=0.15). no significant group difference (p=0.15).)
- Stauder et al. (1991): Strahlentherapeutische Nebenwirkungen bei Abdominalkrebspatienten und deren Reduktion durch hydrolytische Enzyme + (Patients from the enzyme-arm got 102 additional medications, patients from the control-arm got 125 additional medications (p=NI). The duration of taking the additional medication did not differ between the two arms.)
- Lin et al. (2008): Effects of zinc supplementation on clinical outcomes in patients receiving radiotherapy for head and neck cancers: a double-blinded randomized study + (Patients with recurrent disease had signif … Patients with recurrent disease had significantly worse LFS than patients with primary disease (HR, 2.23; 95% CI, 1.17–4.26, p = 0.015) and worse LFS than patients with primary Stages I–II disease (HR, 9.4; 95% CI, 1.22–72.39, p = 0.031),</br>completion of radiotherapy was a significantly beneficial factor for LFS (HR, 6.84; 95% CI, 2.62–17.86, p < 0.001);</br></br>Univariate analysis for patients receiving concurrent chemoradiotherapy: poorer prognosis of patients with recurrent disease than for those with primary disease (HR, 5.25; 95% CI, 2.06–13.42, p = 0.001),</br>better LFS with completion of radiotherapy (HR, 12.49; 95% CI, 2.4–65, p = 0.003),</br>worse LFS of patients in placebo arm than patients in intervention arm (HR, 3.01; 95% CI, 1.1–8.23, p = 0.032);</br></br>Multivariate analysis: placebo arm (HR, 5.25; 95% CI, 1.73–15.88, p = 0.003) and recurrent disease (HR, 8.83; 95% CI, 3.13–24.88, p < 0.001) emerged as independent predictors of poor LFS1) emerged as independent predictors of poor LFS)
- Paur et al. (2017): Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA + (Plasma lycopene values more than doubled i … Plasma lycopene values more than doubled in intervention arms, values in control arm remained the same, significant difference, median, range:</br>tomato arm: 0.25 (-0.12, 0.68); tomato-plus arm: 0.32 (-0.29, 0.75); control arm: -0.02 (-0.15, 0.53); p(tomato / tomato-plus vs. control) <0.001, significant; p(tomato vs. tomato-plus)<0.05, p(tomato-plus)<0.05, significant-plus)<0.05, p(tomato-plus)<0.05, significant)
- 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 + (Pre and post treatment assessment of the wound size, necrotic tissue and type showed no statistical significance (p>0.05). There were no significant differences between the two arms.)
- Fahimi et al. (2011): Evaluating the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens + (Prevalence intervention vs. placebo: * acu … Prevalence intervention vs. placebo:</br>* acute (day 1) 47% vs. 58%, p=0.388, ns.</br></br>* delayed day 2: 44.5% vs. 53%, p=0.508, ns.</br></br>* delayed day 3: 47% vs. 50%, p<0.999, ns.</br></br></br>Severity (Mean(SD)) intervention vs. placebo: </br></br>* acute (day 1): 1.75(2.02) vs. 1.36(1.91), p=0.14, ns.</br></br>* delayed day 2: 1.78(1.93) vs. 1.5(2.03), p=0.31, ns.</br></br>* delayed day 3: 1.61(1.93) vs. 1.47(1.92), p=0.73, ns.</br></br></br>Duration (Mean(SD)) intervention vs. placebo in h:</br></br>* acute (day 1): 2.18(5.03) vs. 2.27(4.88), p=0.93, ns.</br></br>* delayed day 2: 3.06(7.61) vs. 5.10(9.66), p=0.59, ns. </br></br>* delayed day 3: 2.67(6.76) vs. 3.80(8.55), p=0.82, ns.day 3: 2.67(6.76) vs. 3.80(8.55), p=0.82, ns.)
- Fahimi et al. (2011): Evaluating the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens + (Prevalence intervention vs. placebo: * ac … Prevalence intervention vs. placebo: </br>* acute (day 1): 58% vs. 75%, p=0.070, ns.</br></br>* delayed day 2: 75% vs. 81%, p=0.687, ns.</br></br>* delayed day 3: 81% vs. 78%, p<0.999, ns. </br></br></br>Severity (Mean(SD)): </br></br>* acute (day 1): 1.47(2.18) vs. 0.94(1.77), p=0.14, ns. </br></br>* delayed day 2: 1.03(1.89) vs. 0.83(1.84), p=0.72, ns.</br></br>* delayed day 3: 0.80(1.83) vs. 0.92(1.86), p=0.78, ns.day 3: 0.80(1.83) vs. 0.92(1.86), p=0.78, ns.)
- Zick et al. (2008): Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting + (Prevalence of acute nausea, no significant … Prevalence of acute nausea, no significant differences: (without, with aprepitant) (in %): placebo: 20, 10, 1.0g ginger: 21, 12, 2.0g ginger: 23, 8 (p=0.76 and 0.68 respectively);</br>Acute vomiting (without, with aprepitant) (in %): placebo: 11, 6, 1.0g ginger: 14, 5, 2.0g ginger: 11, 3 (p=0.35 and 0.47, respectively)</br></br>Severity of acute nausea, no significant differences: (without, with aprepitant) (Mean±SD): placebo: 3.0±1.1, 2.8±1.5, 1.0g ginger: 3.1±1.2, 2.8±1.1, 2.0g ginger: 2.8±1.3, 3.1±1.5 (p (without, with aprepitant)=0.47, 0.55)</br></br>Severity of acute vomiting, no significant differences: (without, with aprepitant) (Mean±SD): placebo: 2.9±0.9, 3.7±1.5, 1.0g ginger: 3.1±1.4, 3.4±0.6, 2.0g ginger: 3.6±1.4, 4.0±1.7 (p = 0.61, 0.91) ginger: 3.6±1.4, 4.0±1.7 (p = 0.61, 0.91))
- Zick et al. (2008): Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting + (Prevelence, delayed nausea, no significant … Prevelence, delayed nausea, no significant differences (without, with aprepitant) in %: Placebo: 42.5, 25.0, 1.0g ginger: 60,5, 25.6, 2.0g ginger: 50.0, 17.4 (p=0.16) </br>Prevalence, delayed vomiting, no significant differences (without, with aprepitant) (in %): Placebo: 17.5, 12.5, 1.0g ginger: 32.6, 11.6, 2.0g ginger: 52.6, 2.2 (p=0.35 and 0.07 respectively)</br></br>Severity of delayed nausea: (without, with aprepitant) (Mean±SD): Placebo: 3.2±1.1, 3.9±0.9, 1.0g ginger: 3.0±1.1, 2.9±1.3, 2.0g ginger: 3.0±1.3, 2.2±0.7 (p=0.69, 0.01), sign. arm difference for with aprepitant (p=0.01); individual tests show that placebo is significantly higher than 1.0g ginger arm and 2.0g ginger arm (mean±SD: 2.0g ginger=2.8±1.2, 1.0g ginger=2.9±1.1, placebo=3.4±1.1; p=0.03)</br></br>Severity of delayed vomiting, no significant differences: (without, with aprepitant) (mean±SD): A: 3.7±1.0, 3.6±1.3, B: 2.7±0.9, 3.0±1.4, C: 4.0±1.3, 3.0±0.0 (p= 0.88, 0.77)0±1.4, C: 4.0±1.3, 3.0±0.0 (p= 0.88, 0.77))
- 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 cancer + (Quality of life: * Total score (day 8 of … Quality of life: </br>* Total score (day 8 of chemotherapy): Intervention-arm significantly superior MD 4.44, 95%CI 1.13 to 7.76, p<0.001</br></br></br>Subcategories (day 8 of chemotherapy), intervention-arm significantly superior in terms of:</br></br>* Role function: MD 1.94, 95%CI -5.35 to 9.24, p=0.001</br></br>* Fatigue: MD -3.15, 95%CI -8.06 to 1.77, p=0.002</br></br>* Nausea / vomiting: MD -3.61, 95%CI -7.51 to 0.29, p<0.001</br></br>* Pain: MD -2.78, 95%CI -6.59 to 1.03, p=0.017</br></br>* Loss of appetite: MD -6.67, 95%CI -12.50 to -0.83, p<0.001</br></br>* Constipation: MD -1.67, 95%CI -6.25 to 2.92, p=0.046</br></br>* Effect of role function and loss of appetite clinically relevant (10 point difference) appetite clinically relevant (10 point difference))
- Braik et al. (2014): Randomized trial of vitamin B6 for preventing hand-foot syndrome from capecitabine chemotherapy + (Reduction of capecitabine dose (number): i … Reduction of capecitabine dose (number):</br>intervention group: 9 (2 patients grade 3 diarrhoea with necessary hospitalization, 1 patient grade 3 stomatitis, 4 patients grade 3 HFS, 2 patients grade 3 neutropenia)</br>placebo group: 8 (3 patients grade 3 diarrhea, 2 patients grade 3 stomatitis, 3 patients grade 3 HFS)rade 3 stomatitis, 3 patients grade 3 HFS))
- 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 + (Remark: After 3 months: progression in 24 … Remark: </br>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);</br></br>Progression in the intervention arm 15x, placebo arm 14x ITT: HR: 0.97 (95% CI: 0.47, 2.00); p=0.93, not significant% CI: 0.47, 2.00); p=0.93, not significant)
- Sontakke et al. (2003): Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized, cross-over, double blind study + (Reported side effects: oral ulcers (n=3), alopecia (n=5), diarrhea (n=2))
- Jeon et al. (2016): Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial + (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))
- Bairati et al. (2005): A Randomized Trial of Antioxidant Vitamins to Prevent Second Primary Cancers in Head and Neck Cancer Patients + (SPT for '''any supplementation''' beyond 3 … SPT for '''any supplementation''' beyond 3.5 years after randomization:</br>HR = 0.57 (95% CI: 0.31, 1.07), i.e. no significant difference between intervention and placebo arm </br></br>SPT 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>SPT for '''only Vit. E''' beyond 3.5 years after randomization: </br>HR = 0.41 (95% CI: 0.16, 1.03), i.e. no significant difference between intervention and placebo arm</br></br>No influence of smoking statuslacebo arm No influence of smoking status)
- 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 + (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)
- Bairati et al. (2005): Randomized Trial of Antioxidant Vitamins to Prevent Acute Adverse Effects of Radiation Therapy in Head and Neck Cancer Patients + (Side effects for '''any supplementation''' … Side effects for '''any supplementation''' directly post-radiotherapy (T2):</br></br>''All sides'': OR = 0.77 (95% CI: 0.54, 1.09), i.e. no significant difference between intervention and placebo arm</br>''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences</br></br>Side effects for '''beta-carotene + Vit. E''' directly post-radiotherapy (T2):</br></br>''Total'': OR = 0.33 (95% CI: 0.17, 0.65), i.e. significant difference between intervention and placebo arm (lower risk for intervention arm)</br>''Larynx only'': OR = 0.42 (95% CI: 0.23, 0.77), i.e. significant difference between intervention and placebo arm (lower risk for intervention arm)</br>''Skin, mucosa, pharynx and esophagus'': no significant differences</br></br>Side effects for '''only Vit. E''' directly post-radiotherapy (T2):</br></br>''Total'': OR = 1.06 (95% CI: 0.70, 1.60), i.e. no significant difference between intervention and placebo arm</br>''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences</br></br></br>Side effects for '''any supplementation''' 1 month post-radiotherapy (T3):</br></br>''All sides'': OR = 1.11 (95% CI: 0.79, 1.55), i.e. no significant difference between intervention and placebo arm</br>''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences</br></br>Side effects for '''beta-carotene + Vit. E''' 1 month post-radiotherapy (T3):</br></br>''Total'': OR = 0.98 (95% CI: 0.52, 1.87), i.e. no significant difference between intervention and placebo arm </br>''Larynx only'': OR = 0.61 (95% CI: 0.32, 1.17), i.e. no significant difference between intervention and placebo arm </br>''Skin, mucosa, pharynx and esophagus'': no significant differences</br></br>Side effects for '''only Vit. E''' 1 month post-radiotherapy (T3):</br></br>''Total'': OR = 1.17 (95% CI: 0.78, 1.74), i.e. no significant difference between intervention and placebo arm</br>''Larynx, skin, mucosa, pharynx and esophagus'': no significant differencesnd esophagus'': no significant differences)
- Wyatt et al. (2012): Health-Related Quality-of-Life Outcomes: A Reflexology Trial With Patients With Advanced-Stage Breast Cancer + (Sig. better values in reflexology arm than … Sig. better values in reflexology arm than control arm (β= 0.39 [0.13]; p<0.01, reflexology arm: Mean-T1=3.33, Mean-T2=3.36, control arm: Mean-T1 (1 week after last intervention)=3.1 M-T2 (6 weeks after last intervention)=2.9, effect T1 (1 week after last intervention)= 0.36, effect T2 (6 weeks after last intervention)= 0.51). </br>Sig. better values in reflexology arm than in foot massage arm (β=NI; p=0.02, foot massage arm: Mean-T1 (1 week after last intervention)=3.1, Mean-T2 (6 weeks after last intervention) =3.03, effect T1 (1 week after last intervention) =NI, effect T2 (6 weeks after last intervention=NI)ffect T2 (6 weeks after last intervention=NI))
- Wyatt et al. (2012): Health-Related Quality-of-Life Outcomes: A Reflexology Trial With Patients With Advanced-Stage Breast Cancer + (Sig. higher (better) values for reflexolog … Sig. higher (better) values for reflexology arm than control arm (ß= 5.527 [2.728]; p=0.04, reflexology arm: Mean-T1 (1 week after last intervention)= 58.6, Mean-T2 (6 weeks after last intervention) =59.2, control arm: Mean-T1 (1 week after last intervention)= 54.9 Mean-T2 (6 weeks after last intervention)= 51.6, effect T1 (1 week after last intervention=0.21, effect T2 (6 weeks after last intervention) = 0.44). </br>No sig. difference between reflexology arm and control arm (NI)tween reflexology arm and control arm (NI))
- Wyatt et al. (2017): A Randomized Clinical Trial of Caregiver-Delivered Reflexology for Symptom Management During Breast Cancer Treatment + (Sig. lower (better) values for interventio … Sig. lower (better) values for intervention arm than control arm (β= -4.34 [1.85]; p= 0.02), especially in week 2,3 and 5 (week 2: intervention arm: M=27.50 [1.53], control arm: M=33.65 [1.55]; p<0.01; week 3: intervention arm: M= 25. 50 [1.55], control arm: M=30.98 [1.55]; p=0.01; week 5: intervention arm: M=24.64 [1.52], control arm: M=30.50 [1.48]; p<0.01), mainly explained by an improvement in the symptoms fatigue and pain.an improvement in the symptoms fatigue and pain.)
- Wyatt et al. (2017): A Randomized Clinical Trial of Caregiver-Delivered Reflexology for Symptom Management During Breast Cancer Treatment + (Sig. lower (better) values for interventio … Sig. lower (better) values for intervention arm than control arm (β= -3.69 [1.39]; p<0.01) especially in weeks 2,3 and 5 (week 1: intervention arm: M= 14.60 [1.15], control arm: M= 18. 32 [1.17]; p=0.02; week 3: intervention arm: M=11.84 [1.17], control arm: M= 17.57 [1.17]; p<0.01; week 5: intervention arm: M=12.30 [1.15]; control arm: M=16.60 [1.12]; p<0.01).30 [1.15]; control arm: M=16.60 [1.12]; p<0.01))
- Tsay et al. (2008): Effects of Reflexotherapy on Acute Postoperative Pain and Anxiety Among Patients With Digestive Cancer. + (Sig. lower consumption in intervention than arm passive control (mean diff.= 39.59 mg Demerol; p= 0.015))
- Dyer et al. (2013): Is reflexology as effective as aromatherapy massage for symptom relief in an adult outpatient oncology population? + (Significant and clinically relevant improvement in both arms (reflex therapy: M= -1.44 [95%CI: -1.90, -0.97]; p= NI; aroma massage: M= -1.98 [95%CI: -2.49,-1.47]; p= NI), but no significant arm differences (M= 0.54 ([95%CI: -0.14, 1.22]; p= NI))
- Dyer et al. (2013): Is reflexology as effective as aromatherapy massage for symptom relief in an adult outpatient oncology population? + (Significant and clinically relevant improvement over time in both arms (reflexology: M= -0.70 [95% CI: -1.16, -0.24]; aromatherapy massage: M= -1.16 [95% CI: -1.15, -0.80]), but no sig. arm differences (M= 0.45 [95% CI: -0.12, 1.03]; p=NI).)
- 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 + (Significant difference for adjusted physic … Significant difference for adjusted physical functionality between KD arm and ACS arm (p=0.04), but not for mental functionality; no significant arm differences for energy level/fatigue</br></br>Taking into account the decrease in body fat associated with diet, effect on physical functionality no longer significant (p=0.064); decrease in body fat appears to significantly moderate physical functionalitynificantly moderate physical functionality)
- Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial + (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)
- 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 + (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)
- Togni et al. (2015): Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: a randomized placebo controlled trial + (Significant distribution differences betwe … Significant distribution differences between the arms</br>Boswellia arm: more often with mild or moderate erythema (78% compared to 51% in base cream arm)</br>Placebo arm: more often with intense erythema (49% compared to 22% in boswellia arm)</br>Differences in grades of visual intensity of erythema were statistically significant </br>Objective assessment, Computerized photo analysis:</br>Significantly lower magenta color percentage in the boswellia arm (10.1%) compared to the placebo arm (13.3%)</br></br>Higher proportion of patients treated with boswellia cream scored slight intensity of erythema compared to those of base cream arm (50.0% vs 23.0%)</br>A lower fraction of boswellia cream arm patients scored visual intensity of erythema as intense compared to patients of the base cream arm (19.0% vs 48.6%)nts of the base cream arm (19.0% vs 48.6%))
- Khodabakhshi et al. (2019): Feasibility, Safety, and Beneficial Effects of MCT-Based Ketogenic Diet for Breast Cancer Treatment: A Randomized Controlled Trial Study + (Significant effect only for subgroup: overall survival was higher in intervention arm compared to comparison arm for patients undergoing neoadjuvant treatment (p=0.04) after 3 months n = 25 (intervention) + 19 (comparison))
- Freedland et al. (2020): A Randomized Controlled Trial of a 6-month low carbohydrate intervention on disease progression in men with recurrent prostate cancer: Carbohydrate and Prostate Study 2 (CAPS2) + (Significant weight loss in the LCD arm compared to control arm (-12.1 vs -0.50kg; p<0.001, significant))
- Shooriabi et al. (2016): The effect of ginger extract on radiotherapy-oriented salivation in patients with xerostomia: A double-blind controlled study + (Significantly higher increase in intervention-arm than in placebo-arm: Mean (SD) intervention arm vs. placebo arm: 2.051 (0.659) vs. 0.997 (0.947); p<0.01)
- Dardano et al. (2012): The effect of Ginkgo biloba extract on genotoxic damage in patients with differentiated thyroid carcinoma receiving thyroid remnant ablation with Iodine-131 + (Significantly lower increase in "clastogenic" factors in the Ginkgo arm (day 7: Mean=5.0, SD=2.9; day 90: Mean=1.9, SD=0.9) compared to placebo (day 7: Mean=10.5, SD=2.1; day 90: Mean=5.5, SD=1.2), p<0.05)
- Dardano et al. (2012): The effect of Ginkgo biloba extract on genotoxic damage in patients with differentiated thyroid carcinoma receiving thyroid remnant ablation with Iodine-131 + (Significantly lower increase in Micronuclei in the Ginkgo arm (day 7: Mean=11.5, SD=2.4; day 90: Mean=2.9, SD=1.4) compared to placebo (day 7: Mean=17.1, SD=2.3; day 90: Mean=9.0, SD=1.3), p<0.01)
- Togni et al. (2015): Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: a randomized placebo controlled trial + (Significantly lower use of hydrocortisone in the boswellia arm (25%) compared to the placebo arm (63%), p < 0.0001)
- Stauder et al. (1991): Strahlentherapeutische Nebenwirkungen bei Abdominalkrebspatienten und deren Reduktion durch hydrolytische Enzyme + (Single doses: The average single radiation … Single doses: The average single radiation dose was approx. 8% higher in the enzyme-arm at the beginning and approx. 4% higher after 2 and 5 weeks than in the control-arm.</br></br></br>Total dose: After 2 weeks the total dose was about the same in both arms, after 5 weeks the difference between the enzyme-arm and the control-arm was about 16% more in the enzyme-arm.-arm was about 16% more in the enzyme-arm.)
- 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 cancer + (Six months after study termination, a tota … Six months after study termination, a total of 312 deaths (32.7%) had occurred: 138 (29.0%) in the control arm and 174 (36.5%) in intervention arm;</br>primary cause of death was prostate cancer in 108 participants (78.3%) in control arm and 142 (81.6%) in intervention arm,</br>median overall survival was 20.2 months (95% CI, 18.8 to 23.0) in control arm and 17.8 months (95% CI, 16.0 to 19.5) in intervention arm,</br>survival rate was significantly lower in the intervention arm (p = .002)y lower in the intervention arm (p = .002))
- Chung et al. (2016): Randomized Trial of Vitamin C/E Complex for Prevention of Radiation- Induced Xerostomia in Patients with Head and Neck Cancer + (T0: before radiotherapy, T1: 1 month post … T0: before radiotherapy, </br>T1: 1 month post-radiotherapy,</br>T2: 6 months post-radiotherapy</br></br>'''Xerostomia questionnaire''' (mean (SD), no group comparison reported)</br>Intervention arm</br>T0: 5.4 (4.3), T1: 8.1 (4.2), T2: 5.4 (4.0)</br>T0-T1: p = 0.02, T1-T2: p = 0.007</br>Placebo arm</br>T0: 4.6 (3.8), T1: 7.0 (4.5), T2: 7.0 (4.6) </br>T0-T1: p = 0.06 T1-T2: p = 0.97</br></br>'''Xerostomia score''' (no group comparison reported)</br>Intervention arm</br>T0: 2.8 (2.3), T1: 5.0 (2.8), T2: 3.7 (3.9) </br>T0-T1: p = 0.004, T1-T2: p = 0.008</br>Placebo arm</br>T0: 1.7 (1.4), T1: 3.9 (2.4), T2: 3.3 (2.3) </br>T0-T1: p = 0.004, T1-T2: p = 0.47</br></br>'''Salivary scintigraphy'''</br>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), </br>Intervention arm showed better values before (p=0.01) and after stimulation (p=0.009) compared to placebo arm at T1on (p=0.009) compared to placebo arm at T1)
- 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 + (Tendency for fewer patients with progressive disease in boswellia (0%) compared to placebo (18%))