Property:Additional Notes
This is a property of type Text.
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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 +
PRO:
* Ethics vote
* Power analysis was performed and criteria are fulfilled
* Block randomisation with sealed opaque envelopes (by a research assistant)
* Wash out: patients receiving systemic metronidazole or patients treated with topical metronidazole for more than 30 days were excluded
* Control of confounding factors (such as wound size, necrotic tissue and necrotic volume): The characteristics of wounds in both arms were comparable (except patients in Green tea arm had significantly larger wound sizes)
* To ensure internal consistency of data collection, all data collectors participated in structured training sessions conducted by the lead investigator
* Intention-to-treat analysis
CONTRA:
* Overall small sample size
* Probably not blinded (n.a.)
* Group comparability not sufficiently given, difference to baseline: larger wounds in Green tea arm compared to Metronidazole arm (p<0.04)
* Tool for assessing the Quality of life was not validated and is suggestive
* The study is not representative of all cancer patients (as only seriously ill, hospitalised patients were included).
* Short follow-up period +
Lichtmann et al. (2018): Results of a Double-Blind, Randomized, Placebo-Controlled Study of Nabiximols Oromucosal Spray as an Adjunctive Therapy in Advanced Cancer Patients with Chronic Uncontrolled Pain +
PRO:
* Ethical approval
* Intent-to-treat analysis (primary endpoint)
* Multiple testing controlled for endpoints pain and sleep disturbance
* Arms comparable at baseline
CONTRA:
* No information on whether centers were comparable in patient treatment; particularly as “optimal” opioid treatment may vary by country.
* No power analysis
* No details provided on how randomization was conducted or how blinding was ensured
* Correction for multiple testing only for primary endpoint +
Lissoni et al. (1998): Biotherapy with the Pineal Immunomodulating Hormone Melatonin versus Melatonin plus Aloe vera in Untreatable Advanced Solid Neoplasms +
PRO/CONTRA +
Lissoni et al. (2009): A Randomized Study of Chemotherapy versus Biochemotherapy with Chemotherapy plus Aloe arborescens in Patients with Metastatic Cancer +
PRO/CONTRA +
Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial +
PRO:
* Low dropout
* Evenly distributed per arm
CONTRA:
* Very small sample size per arm
* No comparison sample without vitamin C
* Only a few baseline characteristics investigated (no information on cancer stage), arm differences possible. +
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 +
93.3% did not recognize assignment +
M
Mansouri et al. (2016): The Effect of Aloe Vera Solution on Chemotherapy-Induced Stomatitis in Clients with Lymphoma and Leukemia: A Randomized Controlled Clinical Trial +
? +
Mansourian et al. (2015): The effect of "curcuma Longa" topical gel on radiation -induced oral mucositis in patients with head and neck cancer +
PRO:
* Ethics approval obtained
* Double-blinding
CONTRA:
* Small sample size
* No power analysis
* Possible baseline differences cannot be ruled out
* Limited information on baseline characteristics (only gender, age, and radiotherapy dose)
* Poor reporting quality (e.g., no information on cancer types distribution between arms, no data on dropout and compliance) +
Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia +
PRO:
* Ethics vote available.
* Intent-to-treat analysis
* Interim studies for patient safety
* Due to high number of arms and comparisons, significance level set to p≤.001 and Bonferroni corrections applied
CONTRA:
* No control arm (according to the authors, for ethical reasons), also MA/MPA not suitable as a comparison arm.
* LBM with 3 different instruments, but not all patients → Significant increase with DEXA and ANOVA with only 144 patients; survey with CT conducted on only 25 patients (unclear which ones), Group size too small for comparisons.
* No mention of the ANOVA analysis for Arms MA/MPA and EPA
* No statistical data for group comparisons for secondary endpoints
* Arms MA/MPA and EPA removed during interim analysis (unclear when), but analyses still conducted
* No data for time points T1 or T2 +
Margalit et al. (2012): Beta-carotene Antioxidant Use During Radiation Therapy and Prostate Cancer Outcome in the Physicians’ Health Study +
PRO:
* Ethics vote
* Double blinding
* Large sample size
* High compliance rate (80%)
CONTRA:
* Randomization process unclear
* Group differences at baseline (Gleason score ≥ 6: intervention: 43%, control: 33%)
* 6% of the control group also took vitamin A or beta-carotene
* No information on dropout in this specific radiotherapy sample
* Poor report quality, e.g. important patient characteristics missing, hardly any information on the comparison sample +
Martin et al. (2002): Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial +
PRO:
* Intention-to-treat analysis
* Double-blinded
CONTRA:
* No sufficient information on group comparability
* No information on the ethics vote
* Small number of study participants and high attrition
* Time period, but no reasons for attrition given
* Data collection by interview, possibly not an objective survey
* Unclear randomisation process
* Partial lack of group comparisons +
Marucci et al. (2017): Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer +
? +
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 +
Aherence (Number of capsules consumed each day during the study period, min. 3 capsules/day): 71% of all participants, intervention: 67%, placebo: 74%
Quality of patient blinding (success of blinding after 3rd chemotherapy cycle): allocation correctly estimated intervention (63%) vs. placebo (30%) +
Mayne et al. (2001): Randomized Trial of Supplemental beta-Carotene to Prevent Second Head and Neck Cancer +
PRO:
* Ethics vote
* Double blinding
* Large sample size
* Low dropout (intervention: 5%, control: 3%)
* Intention-to-treat analysis
* No group differences to baseline
CONTRA:
* High number of patients dropped out before randomization
* Partially poor report quality (e.g. no information on the period between completion of radiotherapy/surgery and start of intervention) +
Mazdak et al. (2012): Vitamin E reduces superficial bladder cancer recurrence: A randomized controlled Trial +
PRO:
* Ethical approval obtained.
CONTRA:
* No blinding (Control arm receives no alternative to Vitamin E).
* Unclear randomization.
* Small sample size without power analysis.
* No information on dropout.
* No information on compliance.
* Partially incorrect/confusing reporting of results.
* Poor reporting quality (e.g., no information on timing and duration of Vitamin E administration post-surgery, no information on compliance). +
Meyskens et al. (1995): Effects of vitamin A on survival in patients with chronic myelogenous leukemia: a SWOG randomized trial +
PRO:
* Conducting a secondary analysis with more patients included; no differences in outcome
CONTRA:
* No blinding (placebo intervention was too expensive)
* Sample too small according to power analysis (< 150)
* Very high dropout rate intervention > control (23% > 15%), partly because inclusion criteria were tightened +
Minchom et al. (2014): An unblinded, randomised phase II study of platinum-based chemotherapy with vitamin B12 and folic acid supplementation in the treatment of lung cancer with plasma homocysteine blood levels as a biomarker of (...) +
PRO
* Ethics vote
* Precise observation of occurring side effects
* Recording of patient compliance
* Intention-to-treat analyses
* Washout of previous vitamin intake taken into account
* Adjustment of significance level due to multiple testing
CONTRA:
* No blinding
* Not placebo controlled
* Unclear randomization, as groups are not equal in size despite 1:1 distribution
* Simultaneous offer of other supportive therapies whose influence is not considered in detail
* Stage of cancer unclear +
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 +
Note: Chemotherapy compliance: 8x every 3 cycles of cisplatin, 6x 2 cycles, 2x 1 cycle, 1x, 1x no chemotherapy
PRO:
* Ethics approval obtained.
* Participants were instructed to keep a diary of tablet intake.
* Intent-to-treat analysis conducted.
* Sample size calculation performed.
* Measurement of selenium concentration at baseline (no group difference).
* Comparability of groups at baseline established.
CONTRA:
* Very small sample size.
* No indication of selenium deficiencies present.
* Very superficial reporting, particularly in the results section, with little information on blinding.
* No group comparison for number of chemotherapy/radiotherapy side effects or selenium concentration. +
Mondal et al. (2014): Comparative study among glutamine, acetyl-L-carnitine, vitamin-E and methylcobalamine for treatment of paclitaxel-induced peripheral neuropathy +
CONTRA:
* Small sample size.
* No blinding.
* No control group receiving either no intervention or placebo, only active controls whose efficacy is also not proven.
* Possible baseline differences (e.g., in pain perception) were not recorded.
* High dropout rate (overall 44%), with no information on reasons and group distribution.
* No information on compliance.
* Poor reporting quality (e.g., unclear how often patients received the intervention). +