Property:Results after intervention
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Campos et al. (2011): Guarana (Paullinia cupana) Improves Fatigue in Breast Cancer Patients Undergoing Systemic Chemotherapy +
No difference between the arms.
Significantly better sleep within the guarana arm compared to baseline.
Better sleep quality after the use of guarana only in the day 49 comparison and in guarana-placebo arm of the intragroup analysis
Intergroup comparison of guarana and placebo:
Day 21: p = .19
Day 49: p .05 +
Campos et al. (2011): Guarana (Paullinia cupana) Improves Fatigue in Breast Cancer Patients Undergoing Systemic Chemotherapy +
FACIT-F: Significantly lower severity of fatigue with guarana compared to placebo,
Significantly more patients with improved FACIT-F global scores on guarana at days 21 (52% versus 10%) and at day 49 (66% versus 13%) as compared with patients who received placebo.
After day 1: p = 0.09
After day 21: p = < 0.01
After day 49: p = < 0.01
FACIT-ES: Significantly lower expression of endocrine symptoms with guarana compared to placebo
In the intragroup analysis, there were significant differences favoring guarana for the placebo–guarana arm but not for the guarana–placebo arm.
After day 1: p = 0.18
After day 21: p = 0.01
After day 49: p = < 0.01 +
Campos et al. (2011): Guarana (Paullinia cupana) Improves Fatigue in Breast Cancer Patients Undergoing Systemic Chemotherapy +
No difference between the arms. +
Campos et al. (2011): Guarana (Paullinia cupana) Improves Fatigue in Breast Cancer Patients Undergoing Systemic Chemotherapy +
Global Chalder Fatigue Scale: Significant differences favoring guarana, with a drop of -4.6 points in the global score versus a significant increase of + 2.2 points for the arm receiving placebo on day 21, Difference was not significant for the intergroup analysis on day 49.
Guarana significantly improved the Global Chalder Fatigue Scale scores throughout the treatment in the placebo–guarana arm and there was a positive trend in the guarana–placebo arm (p=0.06)
After day 1: p = < 0.01
After day 21: p = < 0.01
After day 49: p = 0.27
BFI: Significantly lower severity of fatigue with guarana compared to placebo.
After day 1: p = NI
After day 21: p = < 0.01
After day 49: p = < 0.01 +
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 +
NA +
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 +
NA +
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 +
NA +
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 +
NA +
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 +
NA +
Chan et al. (2011): Nutritional supplements, COX-2 and IGF-1 expression in men on active surveillance for prostate cancer +
After 12 weeks mean difference:
lycopene: 0.53 ng/ml, fish oil: 0.20 ng/ml, placebo: -0.46 ng/ml; p(lycopene vs. placebo)= 0.26, not significant; p(fish oil vs. placebo) = 0.39, not significant +
Chung et al. (2016): Randomized Trial of Vitamin C/E Complex for Prevention of Radiation- Induced Xerostomia in Patients with Head and Neck Cancer +
'''Overall'''
No significant differences between arms (p = 0.87) +
Chung et al. (2016): Randomized Trial of Vitamin C/E Complex for Prevention of Radiation- Induced Xerostomia in Patients with Head and Neck Cancer +
'''Overall'''
No significant differences between arms (p = 0.75) +
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-radiotherapy,
T2: 6 months post-radiotherapy
'''Xerostomia questionnaire''' (mean (SD), no group comparison reported)
Intervention arm
T0: 5.4 (4.3), T1: 8.1 (4.2), T2: 5.4 (4.0)
T0-T1: p = 0.02, T1-T2: p = 0.007
Placebo arm
T0: 4.6 (3.8), T1: 7.0 (4.5), T2: 7.0 (4.6)
T0-T1: p = 0.06 T1-T2: p = 0.97
'''Xerostomia score''' (no group comparison reported)
Intervention arm
T0: 2.8 (2.3), T1: 5.0 (2.8), T2: 3.7 (3.9)
T0-T1: p = 0.004, T1-T2: p = 0.008
Placebo arm
T0: 1.7 (1.4), T1: 3.9 (2.4), T2: 3.3 (2.3)
T0-T1: p = 0.004, T1-T2: p = 0.47
'''Salivary scintigraphy'''
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),
Intervention arm showed better values before (p=0.01) and after stimulation (p=0.009) compared to placebo arm at T1 +
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 physical functionality between KD arm and ACS arm (p=0.04), but not for mental functionality; no significant arm differences for energy level/fatigue
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 functionality +
Cohen et al. (2018): Favorable Effects of a Ketogenic Diet on Physical Function, Perceived Energy, and Food Cravings in Women with Ovarian or Endometrial Cancer: A Randomized, Controlled Trial +
At 12 weeks significant between-arm difference in the desire to eat something salty, the KD arm craved salt to a greater extent than the ACS arm; difference remained after adjusting for baseline values and chemotherapy status (p = 0.03, significant); no other significant between-arm differences; no significant within-arm differences from baseline to week 12 +
Crew et al. (2012): Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer +
The toxicities did not differ significantly by Poly E dose level or compared with placebo
All DLTs (dose-limiting toxicity) occurred in participants receiving active Poly E. The frequency of DLTs was 6.25% (1 of 16) for dose level 1, 27% (3 of 11) for dose level 2, and 33% (1 of 3) for dose level 3. +
Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study +
Exploratory analysis:
After 4 weeks (end of phase II, PMA Analysis): significant difference between the arms (b=2.58; p=0.003, unadjusted; b=2.7; p=0.002, adjusted), Intervention arm: Baseline: Mean (SD) = 58.2 (8.8) – 4 weeks: Mean (SD) = 64.2 (9.0), Placebo arm: Baseline: Mean (SD) = 57.0 (4.8) – 4 weeks: Mean (SD) = 50.0 (15.5); with higher values for the intervention arm and lower values for the placebo arm +
Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study +
Exploratory analysis:
After 4 weeks (end of phase II; PMA, pattern mixture analysis): greater change for the intervention arm compared to the placebo arm (b=2.6; p=0.03; adjusted), Intervention arm: Baseline: Mean (SD) = 16.0 (8.5) – 4 weeks: Mean (SD) = 22.4 (10.7), Placebo arm: Baseline: Mean (SD) = 11.8 (6.1) – 4 weeks: Mean (SD) = 15.1 (4.8) +
Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study +
Exploratory analysis:
No differences between arms and/or time points for PMA-Analysis +
Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study +
Exploratory analysis:
After 4 weeks (end of phase II, PMA Analysis): significant difference for the functional subscale (b=1.9; p=0.03; unadjusted; b=2.0; p=0.002; adjusted); Intervention arm: Baseline: Mean (SD) = 11.4 (5.1) – 4 weeks: Mean (SD) = 11.0 (3.2), Placebo arm: Baseline: Mean (SD) = 10.8 (6.0) – 4 weeks: Mean (SD) = 9.2 (3.8); this difference is due to the decrease in values in the placebo arm; no direct comparison was conducted +