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- Kraft et al. (2012): L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial + (After 6 weeks: Higher values in cognitive … After 6 weeks: Higher values in cognitive function (p<0.034) in the intervention arm compared to the placebo arm</br>After 12 weeks: Better values for overall health status (p<0.041) and reduced gastrointestinal symptoms (p<0.033) in the intervention arm compared to the placebo armin the intervention arm compared to the placebo arm)
- Kraft et al. (2012): L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial + (After 6 weeks: no significant difference between arms After 12 weeks: significantly higher weight (MD=3.4%; SD=1.35) due to higher body fat percentage (p<0.014) and BCM (p<0.013) in intervention compared to placebo arm)
- Okabayashi et al. (2020): L-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients + (After Surgery: * No significant differenc … After Surgery: </br>* No significant differences between the intervention arm and the control arm in the frequency of postoperative complications, including bile leakage, pleural effusion, respiratory insufficiency, perihepatic abscess, and postoperative ileus.</br>* Classification according to Clavien-Dindo: Morbidity was 10.4% in the control arm and 6.9% in the intervention arm; 7 patients (6%) in the control arm and 3 patients (3%) in the intervention arm had at least one severe complication (Grade III-V), with no significant difference between the groups.</br>* 50-50 criteria: 6 patients (6%) in the control arm and 2 patients (2%) in the intervention arm, with no significant difference between the groups.</br>* PHLF: 12 patients (11%) in the control arm and 6 patients (6%) in the intervention arm, with no significant difference between the groups.significant difference between the groups.)
- Johansson et al. (2021): Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial + (After a median follow-up of 3 years: no difference by treatment in disease-free survival)
- Beer et al. (2007): Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: a report from the ASCENT Investigators + (After adjustment for baseline characterist … After adjustment for baseline characteristics of hemoglobin and Eastern Cooperative Oncology Group performance status, overall survival showed a promising improvement in intervention arm over the placebo arm with a HR of 0.67 (95% CI, 0.45 to 0.97; p = .04)HR of 0.67 (95% CI, 0.45 to 0.97; p = .04))
- Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients + (After chemotherapy (8 days): significant less infections in sodium selenite arm (20%) compared to control arm (67%); p<0.05)
- Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients + (After chemotherapy (8 days): significantly better cardiac ejection fraction in sodium selenite arm (mean(SD)= 63(6%)) vs. control arm (69(6%)); p <0.05)
- Shapiro et al. (2016): Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) + (After the run-in period, the mean baseline … After the run-in period, the mean baseline serum total 25(OH)D level for all participants was 36.6 (13.0) ng/mL (mean (SD)), and free serum 25(OH)D was 8.0 (3.2) pg/mL,</br>5 participants in the intervention arm and 4 participants in the control arm had insufficient 25(OH)D levels of ≤ 20ng/mL and no participants were vitamin D deficient;</br></br>At 6 months, all participants were vitamin D sufficient,</br>statistically significant difference in the change in serum 25(OH)D between arms (a decrease of 2.6 (7.6) ng/mL in control arm vs an increase of 9.3 (10.4) in the intervention arm, p < 0.0001).0.4) in the intervention arm, p < 0.0001).)
- Su et al. (2004): Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasms + (Although the quality of life values favour … Although the quality of life values favoured the aloe group, the differences between the arms were not statistically significantly different.</br>Compared with placebo patients, aloe patients had a lower probability of a 3 point or greater drop in their overall health quality of life score during radiation, although this difference between the arms was not statistically significant.he arms was not statistically significant.)
- Pace et al. (2010): Vitamin E neuroprotection for cisplatin neuropathy + (Amplitude (µV): Mean (SD) N. suralis Inter … Amplitude (µV): Mean (SD)</br>N. suralis</br>Intervention: prior to chemotherapy: 18.3 (9.9), 1 month after chemotherapy: 14.4 (7.1)</br>Placebo: prior to chemotherapy: 23.8 (13.9), 1 month after chemotherapy: 18.3 (12.8)</br>Intervention vs. Placebo: p < 0.05, sign. </br></br>N. medianus</br>Intervention: prior to chemotherapy: 11.4 (5.2), 1 month after chemotherapy: 11.5 (6.3)</br>Placebo: prior to chemotherapy: 15.2 (9.0), 1 month after chemotherapy: 12.4 (8.3)</br>Intervention vs. Placebo: p < 0.01, sign. </br></br>Reflexes and distal paresthesia: Number of patients</br>prior to chemotherapy: Intervention and Placebo: 0</br>1 month after chemotherapy: Intervention: 6/17, Placebo: 13/24</br></br>Neurotoxicity Score 1 month after chemotherapy (based on TNS system): Mean (SD)</br>Intervention: 1.4 (1.5), Placebo: 4.1 (4.5); p < 0.01, sign. </br></br>Number of patients with TNS Grade >3:</br>Intervention: 1/17 (5.9%), Placebo: 10/24 (41.7%); p < 0.01, sign. </br>RR = 0.14 (95% CI: 0.02, 1.00); p < 0.05, sign.1, sign. RR = 0.14 (95% CI: 0.02, 1.00); p < 0.05, sign.)
- 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) + (As many as 99% of zinc-treated patients maintained their weight in contrast to 92% of placebo-exposed patients (p = 0.04))
- Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial + (Assesment weekly: Number of mucositis eve … Assesment weekly:</br></br>Number of mucositis events: vitamin E arm significantly fewer than placebo arm (36 (21.6%) vs. 54 (33.5%); RR = 0.643; 95% KI: 0.42,0.98; p = 0.038, sign. </br>Number of patients with pain/difficulty eating grade 2-3: vitamin E 3 (10.7%) vs. placebo arm 14 (53.8%); p = 0.0001, sign. placebo arm 14 (53.8%); p = 0.0001, sign.)
- Niravath et al. (2019): Randomized controlled trial of high‐dose versus standard‐dose vitamin D3 for prevention of aromatase inhibitor‐induced arthralgia + (At 12 weeks: mean vitamin D level in contr … At 12 weeks: mean vitamin D level in control arm was 29.3 ng/mL, compared to 50 ng/mL in intervention arm, increase and the week 12 level were both significantly higher in the intervention arm (p<0.0001 for both comparisons);</br></br>No correlation between vitamin D level and development of aromatase inhibitor-induced arthralgiaent of aromatase inhibitor-induced arthralgia)
- Niravath et al. (2019): Randomized controlled trial of high‐dose versus standard‐dose vitamin D3 for prevention of aromatase inhibitor‐induced arthralgia + (At 12 weeks: no significant differences; At 52 weeks: no significant differences)
- Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia + (At 16 weeks: Significant increase in combi … At 16 weeks: Significant increase in combination arm (MA/ MPA + EPA + L-Carnitin + Thalidomid) with DEXA (p=0.015), and with CT (increase LBM; kg; p=0.001), but not with BIA </br></br>ANOVA: significant group effect for DEXA (p=0.007): between L-Carnitin arm (Mean Change= -0.7 ±2.2; 95% CI: -1.2, -0.2) and combination arm (MC= 2.1 ± 2.1; 95% CI: 1.6, 2.7; p<0.001) and between Thalidomid arm (MC= -0.8 ± 2.6; 95% CI: -1.5,-0.2) and combination arm (p<0.001), both in favor of combination armm (p<0.001), both in favor of combination arm)
- 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 8 weeks: Full analysis set: Significantly more frequent improvement in values in intervention (29.3%) compared to placebo arm (13%; p < 0.022), also significant in PP-analysis.)
- 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 8 weeks: Full analysis set: no difference between arms PP analysis: less fatigue/improvement of symptoms in intervention compared to placebo arm (intervention: 33.7%, placebo: 18.5%; χ² = 6.100; p = 0.014))
- 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 baseline no significant differences; Significant differences in selenium concentrations (serum and blood) at half of radiotherapy (p<0.0001))
- Johnson et al. (2010): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain + (At days 14-21: Effects for reduction of "c … At days 14-21: Effects for reduction of "cognitive function" in THC:CBD arm and THC arm compared to placebo arm (THC:CBD arm = -5.33 vs. placebo arm = 3.68, p=0.02; THC arm = -6.77 vs. placebo arm = 3.68, p=0.01) </br></br>Worsening of "nausea and vomiting" in THC:CBD arm compared to placebo arm (THC:CBD arm = 5.13 vs. placebo arm = -3.43, p=0.02; THC arm = -3.41 vs. placebo arm = -3.43; p=1.0).</br></br>For "pain" no difference between THC:CBD arm/THC arm and placebo arm.</br></br>For "social function" significant advantage for THC arm over placebo arm (9.66 vs. 1.58; p=0.038).over placebo arm (9.66 vs. 1.58; p=0.038).)
- 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 + (At study termination, 129 deaths (13.5%) had occurred; 48 deaths (10.1%) in the control arm and 81 (17.0%) in intervention arm)
- Rastelli et al. (2011): Vitamin D and aromatase inhibitor-induced musculoskeletal symptoms (AIMSS): a phase II, double-blind, placebo-controlled, randomized trial + (At the end of the study, mean serum 25OHD … At the end of the study, mean serum 25OHD was higher in the intervention arm (p = 0.03) and a greater proportion of subjects normalized serum 25OHD (43% vs. 11.5%, p = 0.02);</br>no linear relationship (r = 0.15, p = 0.5) was found between changes in vitamin D levels and changes in pain scores from baseline to 6 monthss in pain scores from baseline to 6 months)
- Johnson et al. (2010): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain + (Background medication opioids baseline to … Background medication opioids baseline to 14-21 days (median to baseline 271mg daily morphine equivalents): no significant changes in dosage</br></br></br>Breakthrough pain and corresponding opioid use at 14-21 days: </br></br>No difference between arms for number of days used (THC:CBD arm vs. placebo arm, p=0.697; THC arm vs. placebo arm, p=0.555); non-significant reduction in each arm (THC:CBD arm = -0.19 vs. THC arm = -0.14; placebo arm = -0.15) with no difference between arms (THC:CBD arm vs. placebo arm, p=0.688; THC arm vs. placebo arm; p=0.899); more patients in placebo arm (n=7) with increased dosage compared to THC:CBD arm (p=0.004)d dosage compared to THC:CBD arm (p=0.004))
- Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial + (Baseline to 5 weeks: No significant grou … Baseline to 5 weeks: </br></br>No significant group differences between intervention groups combined and placebo: </br></br>* Nabiximol (1-4 sprays) + nabiximol (6-10 sprays) + nabiximol (11-16 sprays) vs. placebo: p=0.072</br></br></br>Mean: </br></br>* Nabiximol (1-4 sprays): baseline = 5.8, day 35 = 4.3</br></br>* Nabiximol (6-10 sprays): baseline = 5.8, day 35 = 4.7 </br></br>* Nabiximol (11-16 sprays): NI</br></br>* Placebo: baseline = 5.7, day 35 = 4.9 </br></br></br>Significant difference between nabiximol (1-4 sprays) and placebo: mean difference (95% CI) </br></br>* Nabiximol (1-4 sprays) vs. placebo = -0.75 (-1.28, 0.22), p=0.006</br></br></br>Otherwise no differences: </br></br>* Nabiximol (6-10 sprays) vs. placebo = -0.36 (-0.89, 0.18), p=0.19 </br></br>* Nabiximol (11-16 sprays) vs. placebo = -0.09 (-0.62, 0.44), p=0.75 vs. placebo = -0.09 (-0.62, 0.44), p=0.75)
- Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial + (Baseline to 5 weeks: Significant differe … Baseline to 5 weeks: </br></br>Significant difference between nabiximol (1-4 sprays) and placebo: mean difference (95% CI) </br></br>* Nabiximol (1-4 sprays) vs. placebo =- 0.73 (-1.30, -0.17), p=0.011</br></br></br>Otherwise no significant differences: </br></br>* Nabiximol (6-10 sprays) vs. placebo = -0.24 (-0.8, 0.3), p=0.4 </br></br>* Nabiximol (11-16 sprays) vs. placebo = -0.6 (-0.6, 0.5), p=0.83ys) vs. placebo = -0.6 (-0.6, 0.5), p=0.83)
- Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial + (Baseline to 5 weeks: no group differences; … Baseline to 5 weeks: no group differences; OR in each case</br></br>* Nabiximol (1-4 sprays) + nabiximol (6-10 sprays) + nabiximol (11-16 sprays) vs. placebo: p=0.59 </br></br>* Nabiximol (1-4 sprays) vs. placebo: 1.37; p=0.33 </br></br>* Nabiximol (6-10 sprays) vs. placebo: 1.19, p=0.61 </br></br>* Nabiximol (11-16 sprays) vs. placebo: 0.9, p=0.76ol (11-16 sprays) vs. placebo: 0.9, p=0.76)
- Zalat et al. (2020): Evaluation of the cardioprotective effects of l-carnitine and silymarin in cancer patients receiving anthracycline-containing chemotherapy + (Baseline to 6 months of chemotherapy: Sign … Baseline to 6 months of chemotherapy: Significant deterioration in control arm (p = 0.00) and significant improvement in carnitine arm (p = 0.002), no change in silymarin arm (p = 0.817);</br>At 6 months: No group comparison presented, but the discussion reports that a difference between the carnitine and control arm was found after chemotherapy. control arm was found after chemotherapy.)
- 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) </br></br>Further results see study [[Hershman et al. (2013): Randomized Double-Blind Placebo-Controlled Trial of Acetyl-L-Carnitine for the Prevention of Taxane-Induced Neuropathy in Women Undergoing Adjuvant Breast Cancer Therapy]][[Hershman et al. (2013): Randomized Double-Blind Placebo-Controlled Trial of Acetyl-L-Carnitine for the Prevention of Taxane-Induced Neuropathy in Women Undergoing Adjuvant Breast Cancer Therapy]])
- Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial + (CINV symptoms: No significant differences … CINV symptoms:</br>No significant differences in prevalence and severity of CINV in all cycles </br>Subgroup analysis: there was no significant arm difference between participants with and without aprepitant</br></br>Anticipatory CINV score: cycle 1: p=0.44; cycle 2: p=0.61; cycle 3: p=0.76</br>Delayed CINV score: cycle 1: p=0.75; cycle 2: p=0.26; cycle 3: p= 0.86 p=0.75; cycle 2: p=0.26; cycle 3: p= 0.86)
- Salihah et al. (2016): The effectiveness of inhaled ginger essential oil in improving dietary intake in breast-cancer patients experiencing chemotherapy-induced nausea and vomiting + (Calorie intake: * sign. main effect time a … Calorie intake:</br>* sign. main effect time and arm; p's< 0.001, no sign. placebo-arm x Time (p=0.638)</br></br>* kcal (Mean(SD)) intervention-arm vs. placebo-arm sign. difference at day 3 (1262.5(239.6) vs. 1237.8(251.9); p=0.015) and day 5 of chemotherapy (1424.9(233.4) vs. (1392.5(235.0); p=0.002)</br></br></br>Covered energy requirement: </br>* Sign. Main effect time and arm; p's< 0.001, no sign. interaction arm x time (p=0.604)</br></br>* In % (Mean±SD) intervention-arm vs. placebo-arm sign. difference at day 3 (77.9(14.3) vs. 76.3(14.5); p=0.010) and day 5 of chemotherapy (87.8(13.7) vs. 85.9(13.9); p=0.002)</br></br></br>Proportions of fat, carbohydrates, protein and fiber:</br></br>* No significant arm differencetein and fiber: * No significant arm difference)
- Cavallini et al. (2005): Acetyl-L-carnitine plus propionyl-L-carnitine improve efficacy of sildenafil in treatment of erectile dysfunction after bilateral nerve-sparing radical retropubic prostatectomy + (Carnitin + Sildenafil Arm and Sildenafil + Placebo Arm had significantly more side effects than the Placebo Arm (χ² = 18.786; p < 0.01), but no difference between the intervention arms)
- Brown et al. (2019): Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Body Composition among Patients with Advanced or Metastatic Colorectal Cancer: A Randomized Trial + (Change in plasma 25(OH)D concentration from baseline to cycle 8 was not significantly associated with change in body weight, body mass index, muscle area, muscle attenuation, visceral adipose tissue area and subcutaneous adipose tissue area)
- Lissoni et al. (2009): A Randomized Study of Chemotherapy versus Biochemotherapy with Chemotherapy plus Aloe arborescens in Patients with Metastatic Cancer + (Chemotherapy was substantially better tole … Chemotherapy was substantially better tolerated in patients concomitantly treated with aloe. In particular, the</br>occurrence of asthenia and/or fatigue was significantly less frequent in patients concomitantly treated with aloe than in those who received chemotherapy alone: Aloe arm = 31/119 (26% ) vs. Control arm = 56/121 (46%), p<0.01. </br></br>VNR-induced constipation was significantly less frequent in the aloe arm than in the control arm: 3/17 (18%) vs. 12/17 (71% ), p<0.01.</br></br>OXA-induced neurotoxicity, with paresthesic disturbances, was less frequent in patients who received aloe with respect to those treated with chemotherapy alone, but without statistically significant differences.t without statistically significant differences.)
- Sahebnasagh et al. (2017): Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial + (Clinical presentation score per arm: Mean … Clinical presentation score per arm: Mean (SD)</br>The aloe arm had a decrease of symptoms from baseline = 4.3 (2.2) to week 4 = 1.2 (0.8). </br></br>The placebo arm had a decrease of symptoms from baseline = 4.2 (1.2) to week 4 = 3.5 (1.1).</br></br>The difference in the clinical presentation scroe between the arms was statistically significant (p=0.008). </br></br>Significantly less diarrhoea (p=0.008) and fecal urgency (p=0.027) in the aloe arm compared to placebo arm.) in the aloe arm compared to placebo arm.)
- Keshavarzi et al. (2019): The effect of vitamin D and E vaginal suppositories on tamoxifen-induced vaginal atrophy in women with breast cancer + (Controlling the duration of tamoxifen use: … Controlling the duration of tamoxifen use: </br>* significant difference of mean vaginal pH before the intervention; significant difference among the three arms 8 weeks after the intervention (pH reduced by 1.59 units in the vitamin E arm and by 1.53 units in the vitamin D arm, but increased by 0.04 units in the placebo arm)</br>* no significant differences in vaginal maturation index before the intervention; difference among the arms was statistically significant at the end of the eighth week of the intervention (VMI increased in the vitamin E and vitamin D arms by the end of the eighth week, and this difference was due to the increase in the mean percentage of superficial cells and the decrease in the mean percentage of parabasal cells in these two arms compared to before the intervention, while no such change was observed in the placebo arm)</br></br></br>Vaginal atrophy: no significant differences before the intervention, but the difference was significant at the second, fourth, and eighth weeks of the intervention (significant reduction in the mean score in the vitamin E and D arms compared with that in the placebo arm)rms compared with that in the placebo arm))
- Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial + (Cycle 1: Intervention significantly superi … Cycle 1: Intervention significantly superior to placebo, clinical relevance minimal</br></br>Nausea-related QoL (median (25th, 75th percentile)) intervention vs. placebo: 124.5 (113.2, 126) vs. 111 (99, 126) (p=0.029)</br></br>CINV-related QoL (median (25th, 75th percentile)) intervention vs. placebo: 124.5 (113.2, 126) vs. 111 (99, 126) (p=0.043)</br></br></br>Cycle 2, cycle 3: no significant differencescle 2, cycle 3: no significant differences)
- Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial + (Cycle 1: mean(SD) intervention vs. placebo: 41.8 (13) vs. 32.2 (10.8), p=0.006 Cycle 3: mean(SD) intervention vs. placebo: 42.4 (10.2) vs. 36.1 (7.2), p=0.013 Intervention arm significantly superior, clinically relevant)
- Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial + (Cycle 1: mean(SD) intervention vs. placebo: 85.1 (18.9) vs. 71.9 (18.3), p=0.015 Cycle 3: mean(SD) intervention vs. placebo: 83.6 (15.0) vs. 75.1 (13.9), p=0.040 Intervention arm significantly superior, clinically relevant)
- 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''' up to 3. … DFS for '''any supplementation''' up to 3.5 years after randomization:</br>HR = 1.65 (95% CI: 1.21, 2.25), i.e. significant difference between intervention and placebo arm (higher risk for intervention arm)</br></br>DFS for '''beta-carotene + Vit. E''' up to 3.5 years after randomization: </br>HR = 1.27 (95% CI: 0.73, 2.21), i.e. no significant difference between intervention and placebo arm</br></br>DFS for '''only Vit. E''' up to 3.5 years after randomization: </br>HR = 1.86 (95% CI: 1.27, 2.72), i.e. significant difference between intervention and placebo arm (higher risk for intervention arm)ebo arm (higher risk for intervention arm))
- 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 + (Day 1 of chemotherapy: Severity of nause … Day 1 of chemotherapy: </br></br>Severity of nausea: </br></br>* intervention-arm significantly less nausea than placebo-arm (treatment effect)</br></br>VAS-Score in mm (mean(SD)) intervention vs. placebo:</br></br>* 38.98(21,65) vs. 42.95(24,82; p=0.040)</br></br>Incidence of vomiting: no significant arm difference</br></br>* p=0.736: no significant arm difference * p=0.736)
- Tan et al. (2018): Bromelain has significant clinical benefits after extraction of the third molar during chemotherapy in patients with hematologic tumor + (Day 1: Enzyme arm = 2.15±0.34 ;control arm = 2.76±0.53 p<0.0001 Day 3: Enzyme arm = 1.16±0.33 ;control arm = 1.83±0.45 p<0.0001 Day 7: Enzyme arm = 0.43±0.12 ;control arm = 1.16±0.27 p<0.0001)
- Tan et al. (2018): Bromelain has significant clinical benefits after extraction of the third molar during chemotherapy in patients with hematologic tumor + (Day 1: Enzyme arm = 2.23(0.34) ;control arm = 2.85(0.43) p<0.0001 Day 3: Enzyme arm = 1.23(0.13) ;control arm = 1.98(0.27) p<0.0001 Day 7: Enzyme arm = 0.23(0.11) ;control arm = 1.01(0.37) p<0.0001)
- Ryan et al. (2011): Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patients + (Day 2, day 3 and follow-up nausea on day 4: delayed nausea: no significant differences between arms.)
- Vinzenz et al. (1992): Die Therapie der radiogenen Mukositis mit Enzymen + (Day after start of radiation: Enzyme arm n … Day after start of radiation: Enzyme arm n(%); control arm n(%)</br></br>5: 1 (5.3%); 0</br></br>6: 2 (10.5%); 1 (5%)</br></br>7: 1 (5.3%); 0</br></br>8: 2 (10.5%); 2 (10%)</br></br>9: 4 (21.4%); 1 (5%)</br></br>10: 3 (15.8%); 4 (20%)</br></br>11: 3 (15.8%); 2 (10%)</br></br>12: 4 (21.4%); 2 (10%)</br></br>13: 0 ; 1 (5%)</br></br>14: 0 ; 1 (5%)</br></br>15: 0 ; 1 (5%)</br></br>16: 0 ; 3 (15%)</br></br>17: 0 ; 1 (5%)</br></br>18: 0; 1 (5%)</br></br>19: 1 (5.3%) ; 1 (5%)</br></br>21: 1 (5.3%) ; 1 (5%): 1 (5.3%) ; 1 (5%) 21: 1 (5.3%) ; 1 (5%))
- Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies + (Deterioration in both arms after 5 weeks: * Sativex arm: from 3.2 to 3.7, Placebo arm: 3.1 to 3.6. (treatment effect -0.02; 95% CI: -0.42, 0.38; p = 0.917) * No differences for individual subgroups (no US patients in this study))
- Uthaipaisanwong et al. (2020): Effects of ginger adjunct to the standard prophylaxis on reducing carboplatin and paclitaxel-induced nausea vomiting: a randomized controlled study + (Diarrhea: ginger vs. placebo: 27.7% vs. 36.2% (p=0.34), no significant difference Heartburn: ginger vs. placebo: 8.5% vs. 12.8% (p=0.38), no significant difference Constipation: ginger vs. placebo: 14.9% vs. 4.3% (p=0.09), no significant difference)
- Jatoi et al. (2002): Dronabinol Versus Megestrol Acetate Versus Combination Therapy for Cancer-Associated Anorexia: A North Central Cancer Treatment Group Study + (Difference baseline to end of study (6-wee … Difference baseline to end of study (6-week median time): </br></br>* No differences for Uniscale; in the FAACT-AN significant advantage for Megestrol Acetate arm over Dronabinol arm (p=0.002), as well as in individual scales physical and emotional constructs; except for emotional constructs (Megestrol Acetate arm better than Megestrol Acetate + Dronabinol arm)</br>* No differences between Megestrol Acetate arm and Megestrol Acetate + Dronabinol armarm and Megestrol Acetate + Dronabinol arm)
- Jacot et al. (2016): Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study + (Difference in baseline Quality of Life for … Difference in baseline Quality of Life for the physical function (p = 0.028), higher in the intervention arm and diarrhea, more severe in the control arm (p = 0.093);</br>no statistically significant difference was observed between intervention and control arms at 6 months,</br>there was no significant difference in overall Quality of Life between the normalized and deficient populations at 6 monthsized and deficient populations at 6 months)
- Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial + (Difference in kg (Mean baseline - mean during radiotherapy): vitamin E arm: 4.9, placebo arm: 5.5; p = 0.249, ns.)
- Arbabi-kalati et al. (2012): Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: A double-blind randomized clinical trial + (During 2nd week no statistically significa … During 2nd week no statistically significant differences in the arms;</br>during 4th week the intensity of xerostomia in the drug arm was less than the placebo arm (p < 0.005), a trend which continued until the 16th week of treatment;</br>during 18th week no differences;</br>during 20th week significantly lower in the intervention arm (p < 0.005)</br></br>No significant differences in terms of xerostomia treatment</br></br>Increased drug effect with decreased xerostomia intensity over increased time in the intervention arm (p < 0.005).reased time in the intervention arm (p < 0.005).)
- Dale et al. (2001): Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects + (During radiation therapy patients initiall … During radiation therapy patients initially exhibited patchy vaginal mucositis which gradually progressed to confluent fibrous mucositis. 41.6% of both arms experienced mild pain. 16.6% of the control-arm exhibited patchy mucositis with serosanguineuos discharge. They also experienced moderate pain requiring the use of analgesics. 6.6% of the enzyme arm showed similar signs and symptoms.yme arm showed similar signs and symptoms.)