Williams et al. (1996): Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity

Reference ↗
Title	Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity
Topic	Aloe vera
Author	Williams, MS, Burk, M, Loprinzi, CL, Hill, M, Schomberg, PJ, Nearhood, K, O'Fallon, JR, Laurie, JA, Shanahan, TG, Moore, RL, Urias, RE, Kuske, RR, Engel, RE, Eggleston, WD
Year	1996
Journal	International Journal of Radiation Oncology, Biology, Physics
DOI	https://doi.org/10.1016/s0360-3016(96)00320-3

Brief summary

In this study, researchers investigated the effect of an aloe vera gel (98%) on radiation-induced dermatitis. Women with breast carcinoma who underwent radiotherapy applied either the aloe gel or a placebo gel to the irradiated skin. Both the patients and their treating doctor or nurse assessed the severity of their skin reactions each week. At the end of the study, there were no differences between the aloe vera arm and the placebo arm, nor between the aloe vera arm and the control arm without treatment. The aloe gel also failed to demonstrate any effect compared to no treatment. The researchers found no evidence that the use of aloe vera gel could prevent dermatitis caused by radiotherapy.

In dieser Studie untersuchten Forscher die Wirkung eines Aloe Vera Gels (98%) auf strahlungsinduzierte Dermatitis. Frauen mit einem Mammakarzinom, die sich einer Strahlentherapie unterzogen, trugen entweder das Aloe-Gel oder ein Placebo-Gel auf die bestrahlte Haut auf. Sowohl die Patientinnen als auch ihr behandelnder/e Arzt/Ärztin oder Krankenpfleger/in bewerteten jede Woche die Schwere ihrer Hautreaktionen. Am Ende der Studie gab es weder Unterschiede zwischen dem Aloe Vera Arm und dem Placebo Arm, noch zwischen dem Aloe Vera Arm und dem Kontroll-Arm ohne Behandlung, . Im Vergleich zu keiner Therapie hat das Aloe-Gel auch keine Wirkung nachweisen können. Die Forscher fanden keinen Beweis dafür, dass die Anwendung eines Aloe-Vera-Gels Dermatitis durch eine Strahlentherapie verhindern könnte.

Study Design

Prospective / Retrospective Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies;</br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies	?
Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals	?
Blinding No: Open, all parties are aware of group assignments;</br>Single: one party is unaware of group assignments (generally participants);</br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties	?
Is randomized	Yes
Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control	No
Number of arms	-999

Study characteristics

Inclusion criteria	?
Exclusion criteria	?
N randomized	-999
Analysis PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.	?
Specifications on analyses	?
Countries of data collection	?
LoE Level of evidence	?
Outcome timeline Data collection times	?

Characteristics of participants

Setting Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.	?
Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included	?
Cancer stages Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis	?
Specifications on cancer stages	?
Comorbidities	?
Current cancer therapies	?
Specifications on cancer therapies	?
Previous cancer therapies	?
Gender	?
Gender specifications	?
Age groups
Age groups specification	?

Funding and Conflicts of Interest

Funding	?
Conflicts of Interest	?

Further points for assessing the study

Sample

Power analysis performed	?
- Sample size corresponds to power analysis	?
- Reasons for insufficient sample size based on power analysis	?
If no power analysis performed: at least moderate sample size (n >= 30 per arm)	?
Ethnicity mentioned	?

Alternative Explanation

Other explanations for an effect besides the investigated intervention	?
- Possibility of attention effects	?
- Possibility of placebo effects	?
- Other reasons	?

Statistics

Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing	?
Correction for multiple testing	?
Measurement of compliance	?
Consistent reporting in numbers (figures, flowchart, abstract, results)	?
Comprehensive and coherent reporting	?
Cross-over	?
- Sufficient washout period	?
- Tested for carry-over effects	?
- Tested for sequence effects	?

Interpretation of results

Effect sizes reported (clinical vs. statistical significance)	?
Side effects systematically recorded	?
Side effects considered in result interpretation	?
Ethics votum	?

Additional Notes

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