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- Argyriou et al. (2006): Preventing Paclitaxel-Induced Peripheral neuropathy: A Phase 2 Trial of Vitamin E Supplementation + (Number with PIPN ITT: intervention arm: 5/ … Number with PIPN</br>ITT: intervention arm: 5/18 (27.8%); control arm: 13/19 (68.4%); p = 0.032</br>PP: intervention arm: 3/16 (18.7%); 10/16 (62.5%); p = 0.03; RR = 0.3 (95% CI: 0.1, 0.9)</br></br>PIPN score. Mean (SD): </br>ITT: not reported </br>PP: intervention arm: 2.25 (5.1) (range: 0-15), control arm: 11 (11.63; range: 0-32); p = 0.01</br></br>Neurolog. Data (number of patients)</br>intervention arm: mainly numbness/paresthesia limited to fingers/toes (n = 1), stocking-and-glove distribution (n = 2), ankle hyporeflexia ( n = 2)</br>control arm: mainly numbness/paresthesia limited to fingers/toes (n = 3), or extended to knees/elbows ( n = 3), stocking-and-glove distribution (n = 4)</br></br>Neurophysiolog. Data</br>In each case sign. Difference in amplitude sensor. Action potential: </br>N. ulnaris (p = 0.014), peroneus superfic. (p = 0.003); sural nerve (p = 0.008)</br>Otherwise no sign. differences(p = 0.008) Otherwise no sign. differences)
- Okabayashi et al. (2020): L-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients + (One death occurred 62 days post-operation … One death occurred 62 days post-operation in the control arm (segmentectomy) due to bleeding from esophageal varices 2 weeks after surgery, followed by multi-organ failure. No other surgical mortalities or readmissions related to the surgery were reported.ions related to the surgery were reported.)
- Najafizade et al. (2013): Preventive effects of zinc sulfate on taste alterations in patients under irradiation for head and neck cancers: A randomized placebo-controlled trial + (One month after completion of radiotherapy: taste perception threshold was increased in the placebo arm for al four tastes (p = 0.001), in the intervention arm, there was only slight increase in threshold for perception of the salty taste (p = 0.046))
- 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 + (Only one patient from the intervention arm did not reach CR and died)
- Raei et al. (2013): Effect of herbal therapy to intensity chemotherapy-induced nausea and vomiting in cancer patients + (Over both cycles: 1. nausea score after 24 … Over both cycles:</br>1. nausea score after 24 hours</br>2. nausea score 3 hours after first dose</br></br>Sign. Treatment effect in favor of ginger after 3 or 24 hours: Within-group comparison between cycles 1-2: </br>Arm 1 </br>Verum-placebo</br>MD - 0.93±3.39</br>Arm 2</br>Placebo - verum</br>MD 1.80±2.33 </br>Then t-test inter-group comparison with above values: </br>Ta = -2.571, df = 28, p = 0.01</br></br>Comparison of the cross-over regimes and the comparison between the two cycles showed no differences, i.e. ginger was superior to placebo in both cycles, irrespective of cycle and armboth cycles, irrespective of cycle and arm)
- Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial + (Over the course of the intervention and after: no difference (p=0.3295) between arms)
- Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial + (Over the course of the intervention and after: no differences for pain (p=0.6048), analgesic use (p=0.6671), no delay in time to 20% pain increase (p=0.4614) between arms)
- Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial + (Over the course of the intervention and after: no difference for nausea (p=0.7105) or antiemetic consumption (p=0.6124) between arms)
- Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial + (Over the course of the intervention and after: no difference for weight fluctuations (p=0.1454) or need for a feeding tube (no p-value) between arms.)
- Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial + (Over the course of the intervention and after: no differences for mood (p=0.3214) and sleep quality (p=0.4438) between arms)
- Muecke et al. (2010): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology + (Overall incidence of grade 2 diarrhea: intervention arm 20.5% vs. control arm 44.5% (p = 0.04))
- Bossi et al. (2017): A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin + (Overall no significant arm difference Subgroup analysis: Women and patients with head and neck tumors significantly higher in intervention than in placebo (7.31; 95% CI 14.56/0.06, p=0.048 and 7.43; 95% CI 14.42/0.43, p=0.038, respectively))
- Afonseca et al. (2013): Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: A pilot randomized clinical trial + (Overall number (%): Diarrhea: intervention … Overall number (%):</br>Diarrhea: intervention arm: 10 (55.6) (grade 1: n = 5, grade 2: n = 5); placebo arm: 4 (18.8) (grade 1: n = 3, grade 3: n = 1); p = 0.06;</br>No differences with regard to nausea (p = 0.36), vomiting (p = 0.38), mucositis (p = 0.38), fatigue (p = 0.20), headache (p = 0.45), dizziness (p = 0.54), bleeding (p = 0.90) dizziness (p = 0.54), bleeding (p = 0.90))
- 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: (1) Blood: Resveratrol concentrat … Overall:</br>(1) Blood: Resveratrol concentrations were below the lower limits of quantitation (LLOQ) for all samples from subjects receiving placebo, and measurable in patients who received SRT501. Cmax levels were reached 2.8 h post-dose, and the mean maximum plasma concentration was 1942 ng/mL (8.51 nmol/mL). The mean plasma elimination half-life was just over 1h.</br></br>(2) Tissue: Levels of resveratrol were below the LLOQ in all subjects on placebo and one of the six patients on SRT501. Mean resveratrol levels in the remaining five patients receiving SRT501 were 1098±1393 ng/g (4.81 nmol/g, range 52-2834 ng/g) and 420±341 ng/g (1.84 nmol/g, range 46-914 ng/g) in tumor and normal tissue, respectively. in tumor and normal tissue, respectively.)
- 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: Median in days (95% CI) intervention arm: 36 (28.0, 44.0); placebo arm: could not be calculated as symptom reduction occurred in only 27 patients)
- 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: Median in days (95% CI) intervention arm: 58 (43.0, 97.0); placebo arm: 69 (49.0, 105.0); p = 0.58, ns.)
- 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))