Property:Additional Notes
This is a property of type Text.
M
Muecke et al. (2010): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology +
PRO:
* Ethics approval obtained.
* Testing for selenium deficiency.
* Power analysis conducted.
* Comparability of arms established.
* Very detailed and clear presentation of results.
CONTRA:
* No placebo control.
* No information on possible blinding.
* No information on potential dropouts.
* "Total dose of external radiotherapy (Gy)" at p=0.06 — close to significance between arms.
* No testing whether selenium significantly decreases in the control arm.
* No verification of supplementation outside the study.
* Few demographic variables provided. +
Muecke et al. (2013): Impact of treatment planning target volumen (PTV) size on radiation induced diarrhoea following selenium supplementation in gynecologic radiation oncology-a subgroup analysis of a multicenter, phase III trial +
PRO:
* Ethics approval obtained.
* Testing for selenium deficiency.
* Power analysis conducted.
* Comparability of arms established.
* Very detailed and clear presentation of results.
CONTRA:
* No placebo control.
* No information on possible blinding.
* No information on potential dropouts.
* "Total dose of external radiotherapy (Gy)" at p=0.06 — close to significance between arms.
* No testing whether selenium significantly decreases in the control arm.
* No verification of supplementation outside the study.
* Few demographic variables provided. +
Muecke et al. (2014): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology: follow-up analysis of the survival data 6 years after cessation of randomization +
PRO:
* Ethics approval obtained.
* Testing for selenium deficiency.
* Power analysis conducted.
* Comparability of arms established.
* Very detailed and clear presentation of results.
CONTRA:
* No placebo control.
* No information on possible blinding.
* No information on potential dropouts.
* "Total dose of external radiotherapy (Gy)" at p=0.06 — close to significance between arms.
* No testing whether selenium significantly decreases in the control arm.
* No verification of supplementation outside the study.
* Few demographic variables provided. +
N
Nguyen et al. (2012): Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities +
PRO:
* Ethics vote
* Wash out: Patients who drank tea regularly within one month of enrolment were excluded
* Control of treatment adherence (number of capsules and intake calendar)
* Testing of the normal distribution of the data and application of adequate tests
CONTRA:
* Overall small sample size (post-hoc power analysis performed and criteria not fulfilled)
*Intention-to-treat evaluation of side effects (underestimation of side effects, per-protocol would be better, but only 4% did not complete the study)
* Per-protocol evaluation of endpoints (intention-to-treat would be better)
* Unclear randomisation process
* No correction for multiple testing for comparison between arms for changes (but at least insight into this and cautious interpretation)
* No indication of the data collection site
* No explanation of blinding process +
Niravath et al. (2019): Randomized controlled trial of high‐dose versus standard‐dose vitamin D3 for prevention of aromatase inhibitor‐induced arthralgia +
PRO:
* Ethics vote
* Intention to treat analysis
* Adherence controlled with pill counting
* Power analysis
* Comparability of the groups to the baseline
CONTRA:
* Sample too small in view of the power analysis (about half); early discontinuation of study recruitment as no effect could be found at T1
* No blinding
* Patients who did not complete HAQ-II after 12 weeks were interpreted as having developed AIA
* For compliance, too few complete data sets were available to perform analyses, so general compliance was also unclear +
O
Okabayashi et al. (2020): L-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients +
PRO:
* Ethical approval obtained.
* Large sample size.
* Study registered.
* Baseline comparison conducted.
* Power analysis performed.
CONTRA:
* No description of the randomization process.
* Financial support was initially not disclosed, but later indicated.
* Open design.
* PHLF: Table in article shows n=5 in the control arm, but text reports n=6.
* No information on the treatment of the control group.
* No control for multiple testing. +
Olsen et al. (2001): The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy +
PRO/CONTRA +
P
Pace et al. (2003): Neuroprotective Effect of Vitamin E Supplementation in Patient Treated With Cisplatin Chemotherapy +
PRO:
* Baseline vitamin E levels reported.
CONTRA:
* No blinding.
* Small sample size without power analysis.
* Very high dropout rate: 43%, with no information on distribution between arms.
* No intention-to-treat analysis.
* Poor reporting quality (e.g., no information on changes in vitamin E levels and compliance, possible selective reporting of endpoints). +
PRO:
* Ethical approval obtained.
CONTRA:
* Small sample size (less than calculated in power analysis, N < 80).
* Very high dropout rate (A: 69%; B: 56%, main reason: Cisplatin dose < 300 mg/m²).
* No intention-to-treat analysis.
* Homogeneity of variance likely not met in some statistical analyses.
* Poor reporting quality (e.g., no information on compliance). +
Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial +
PRO:
* Ethical approval
* Intent-to-treat analysis
* Power analysis
CONTRA:
* Differences in treatment adherence
* Some descriptive differences at baseline without p-values provided (e.g., pain duration)
* Post-hoc analyses reveal confounding variables associated with higher mortality rates in intervention arms: high white blood cell count, low calcium, hemoglobin, and lymphocyte levels, raising doubts about group comparability.
* In analyses of subjective pain perception, changes in opioid consumption were not controlled for.
* Mostly one-dimensional pain parameters were considered.
* Results in the text are reported unclearly, with some values missing or not precisely specified.
* No information on cancer stage.
* Poor reporting quality.
* Correction for multiple comparison only for primary endpoints +
Puataweepong et. al (2009): The efficacy of oral Aloe vera juice for radiation induced mucositis in head and neck cancer patients: a double-blind placebo-controlled study +
? +
R
Raei et al. (2013): Effect of herbal therapy to intensity chemotherapy-induced nausea and vomiting in cancer patients +
? +
Rao et al. (2014): The Indian Spice Turmeric Delays and Mitigates Radiation-Induced Oral Mucositis in Patients Undergoing Treatment for Head and Neck Cancer: An Investigational Study +
PRO:
* Ethics approval obtained
* Active control
* Large sample size according to power analysis calculation
* Low dropout (Curcumin arm: 2.5%, Povidone-iodine arm: 0%)
CONTRA:
* Curcumin arm must rinse mouth much more frequently than Povidone-iodine arm
* Poor reporting quality (e.g., some numbers can only be derived from graphs) +
Raoufinejad et al. (2019): Oral calcitriol in hematopoietic recovery and survival after autologous stem cell transplantation: a randomized clinical trial +
PRO:
* Ethics vote
* Power analysis
* Intent-to-treat analysis
CONTRA:
* Heterogeneity concerning types of cancer
* Indication of randomization but then reports “KR enrolled the participants and assigned them to interventions.”
* No control for multiple testing
* No information whether there was comparability testing of the groups at baseline +
Rostock et al. (2013): Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Four-Arm Randomized Trial on the Effectiveness of Electroacupuncture +
PRO:
* Ethics vote available
* Calculation of power analyses
* Intention-to-treat analyses
* Double-blinded if possible
CONTRA:
* Small sample size
* Low intensity of complaints, which left little room for improvement (floor effect)
* Possibility of confounding variables exists (medication and other concurrent therapies, inequality of cancer treatment medication use between arms caused by unequal distribution of cancer types (n.s.), also descriptive inequality of symptoms (n.s))
* Little detailed description of the follow-up results (overall concise results section) +
Ryan et al. (2013): Curcumin for radiation dermatitis: a randomized, double-blind, placebo-controlled clinical trial of thirty breast cancer patients +
PRO:
* Ethical approval obtained
* Double-blind with control (Intervention arm: 5/14 (35.7%) of patients think they are in the curcumin arm, placebo arm: 2/16 (12.5%) of patients think they are in the placebo arm).
* High comparable compliance rates (Mean (SD): Intervention arm: 96.6% (6.6%), Placebo arm: 98.4% (3.2%); p = 0.344)
* Assessment of expected and actual pain at baseline
CONTRA:
* Very small sample size
* Dropout rate: Intervention arm: 18%, Placebo arm: 11%
* No intention-to-treat analysis
* No control for multiple testing +
S
Sahebjamee et al. (2015): Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial +
? +
Sahebnasagh et al. (2017): Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial +
? +
Salehi et al. (2015): Effect of Vitamin E on Oxaliplatin-induced Peripheral neuropathy Prevention: A Randomized Controlled Trial +
PRO:
* Ethical approval obtained.
* Low dropout rate (A: 9%, B: 6%).
* Intention-to-treat analysis conducted.
CONTRA:
* No blinding.
* Sample size smaller than calculated in power analysis.
* Peripheral neuropathy not differentiated by CTCAE grades.
* No information on compliance.
* Poor reporting quality (e.g., no information on cancer stage). +