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- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (Adverse events were observed in 21 out of … Adverse events were observed in 21 out of 29 patients (hospice patients); 7 were hospitalized (intervention arm: 4 times, placebo arm: 3 times). Fifteen hospice patients and eight non-hospice patients reported adverse events, including:</br>Nausea/vomiting (intervention arm: 2 times); Stomach problems (intervention arm: 2 times); Increased pain (placebo arm: 2 times); Diarrhea (intervention arm: 2 times); Confusion (placebo arm: 1 time); Tinnitus (placebo arm: 1 time)</br></br>According to the authors, only one case of constipation and one case of diarrhea were associated with carnitine.f diarrhea were associated with carnitine.)
- 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 + (After 12 weeks: Lower values for the inte … After 12 weeks: </br>Lower values for the intervention arm (higher CIPN) compared to the placebo arm (Baseline to 12 weeks: Intervention: -5.2 points vs. Placebo: -4.5 points), but the difference is not significant (linear regression, adjusted for baseline values: 0.9 points between arms, 95% CI: -2.2, 0.4; p = 0.17). There is a higher likelihood for the intervention arm to decrease by more than 5 points on the FACT-NTX, but this is not significant (OR: 1.48; 38% vs. 30%; p = 0.08)</br></br>After 24 weeks: </br>Baseline to 24 weeks: Intervention arm -5.3 points vs. placebo arm -3.6 points; linear regression: the intervention arm had 1.8 points less than the placebo arm, indicating a significant difference between arms (95% CI: -3.2, -0.4; p = 0.01), meaning more self-reported neuropathy symptoms in the intervention arm. There is a greater likelihood for the intervention arm to decrease by more than 5 points on the FACT-NTX (OR: 1.57; 38% vs. 28%; p = 0.05).ACT-NTX (OR: 1.57; 38% vs. 28%; p = 0.05).)
- 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 + (After 12 weeks: No difference in the inte … After 12 weeks: </br>No difference in the intervention arm (Baseline: M = 99.3 – 12 weeks: M = 91.9; MD = 7.4) compared to the placebo arm (Baseline - 12 weeks MD = 7.4); p = 0.92.</br></br>After 24 weeks: </br>Mean difference between the intervention arm and the placebo arm = 3.5 points; 95% CI: -6.5, -0.4; p = 0.03, representing a significant reduction in the intervention arm compared to the placebo arm.ervention arm compared to the placebo arm.)
- Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia + (After 16 weeks: Significant decrease in combination arm (MA/ MPA + EPA + L-Carnitin + Thalidomid; p=0.008, p<0.0001), Thalidomid arm (p=0.006, p<0.0001), and L-Carnitin arm (p=0.030, p=0.0001; GPS and ECOG PS); no comparison between arms conducted.)
- Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia + (After 16 weeks: Significant improvement in … After 16 weeks: Significant improvement in combination arm (MA/ MPA + EPA + L-Carnitin + Thalidomid, p=0.047); </br></br>ANOVA: significant group effect [p.035]), between L-Carnitin arm (MC= 0.85 ±19.5 [95% CI: -3.6, -5.3]) and combination arm (MC= -7.5 ± 12.8 [95% CI:-10.4,-4.6]); p=0.004), in favor of combination arm6]); p=0.004), in favor of combination arm)
- Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia + (After 16 weeks: Significant reduction in c … After 16 weeks: Significant reduction in combination arm (MA/ MPA + EPA + L-Carnitin + Thalidomid, p=0.044); </br></br>ANOVA: significant group effect (p=0.028): between L-Carnitin arm (MC= 12.08 ± 246; 95% CI: -47.9, -72.08) and combination arm (MC: -133 ± 259; 95% CI: -200, -65.4; p=0.004); in favor of combination arm5.4; p=0.004); in favor of combination arm)
- Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia + (After 16 weeks: TEE and AEE significantly increased in arm MA/ MPA + EPA + L-Carnitin + Thalidomid (p<0.05); no comparison beetween arms performed)
- Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia + (After 16 weeks: significant increase in combination arm (MA/ MPA + EPA + L-Carnitin + Thalidomid; p=0.00037); no comparison between arms conducted)
- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (After 2 weeks (end of phase I, ITT-Analysis and PP-Analysis): No differences between arms and/or time points)
- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (After 2 weeks (end of phase I, ITT-Analysis and PP-Analysis): No differences between arms and/or time points)
- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (After 2 weeks (end of phase I, ITT-Analysis and PP-Analysis): No differences between arms and/or time points)
- Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study + (After 2 weeks (end of phase I, ITT-Analysis and PP-Analysis): No differences between arms and/or time points)
- Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…) + (After 2 weeks: improvement of all arms by 5% (no statistical values/comparisons) After 6 weeks: further 5% improvement for Placebo arm, after 2 weeks unchanged for THC arm and decline by 2.5% for Cannabis extract arm (no statistical values/comparisons))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 3 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 45.1 (22.4), pentoxyfillin + placebo: 18.9 (18.3), vitamin E + placebo: 34.8 (23.8); placebos: 36.2 (13.5))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 3 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 20.2 (10.6), pentoxyfillin + placebo: 10.5 (11.5), vitamin E + placebo: 15.2 (16.1); placebos: 24.7 (13.1))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 3 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 34.7 (20.6), pentoxyfillin + placebo: 18.9 (18.3), vitamin E + placebo: 25.8 (21.8); placebos: 29.2 (10.3))
- Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial + (After 4 and 8 weeks: no difference between arms (p=0.13, p=0.63))
- Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial + (After 4 weeks: no difference between arms for pain intensity: p=0.61, disturbance due to pain: p=0.75)
- Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial + (After 4 weeks: no difference between arms (p=0.61))
- Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial + (After 4 weeks: no difference between arms (p=0.93))
- Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial + (After 4 weeks: significant difference between arms, with higher proportion of carnitine deficit in placebo arm (intervention arm: 11%, placebo arm: 33%; p≤.001))
- Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial + (After 5 weeks: No significant differences.)
- Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial + (After 5 weeks: Small effect of nabiximol on EORTC-QCQ-C30 (no values given), otherwise no significant differences for questionnaires.)
- 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 + (After 6 months, significantly more patient … After 6 months, significantly more patients in the intervention arm had a normalized serum vitamin D level compared with the control arm patients (30% versus 12.6%; p = 0.003),</br>the median 6 month-vitamin D level was 24.2 ng/ml (8.1–39.2) and 28.1 ng/ml (7.3–51.8) respectively in the control and intervention arms (p < 0.001);</br></br>Percentage of correction was significantly higher in the intervention arm for patients included during fall (28% vs. 3%; p = 0.006), there was a trend in favor of intervention arm for patients included during winter (52% vs. 28%; p = 0.083), while there was no significant difference for patients included in spring and summer;e for patients included in spring and summer;)
- Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…) + (After 6 weeks: No significant differences between Cannabis extract arm and Placebo arm (ITT p=0.80) or THC arm and Placebo arm (ITT p=0.43), as well as THC arm and Cannabis extract arm (PP analysis p=0.90))
- Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…) + (After 6 weeks: No significant differences between the intervention arms and placebo arm for mean improvement (ITT Cannabis extract vs. Placebo p=0.46, THC vs. Placebo p=0.95) or increased appetite (p=0.068))
- 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).)