Olsen, D. L., Raub, W., Jr., Bradley, C., Johnson, M., Macias, J. L., Love, V., & Markoe, A. (2001). The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy. Oncology Nursing Forum, 28, 543–547.

Study Purpose

To determine if the use of aloe and mild soap versus mild soap (Dove) alone would decrease the incidence of skin reactions. Aloe gel included aloe vera, triethanolamine, d-α tocopherol (natural Vitamin E), carbomer, tetrasodium ethylenediaminetetraacetic acid (EDTA), methylparaben, and imdazolidinyl urea.

Intervention Characteristics/Basic Study Process

Participants were randomized to use aloe vera gel and mild soap or mild soap alone. The skin care regimen began on the first day of treatment. Aloe was to be applied liberally after treatment each day, reapplied throughout the day, and rinsed off prior to treatment (no time frame identified). Assessments were performed on day 1 and in weekly reviews. Clinicians could order supplemental skin products as they deemed necessary.

Sample Characteristics

  • The sample was comprised of 70 patients (34% male, 48% female).
  • Age was: 45 years (18% in each study group), 45–59 years (55% aloe/soap; 32% soap alone), and older than 59 years (27% aloe/soap; 50% soap alone).
  • Patients had cancer of the head and neck (39%), chest (58%), and extremities (3%).
  • Mean cumulative dose was 2,700 cGy (range 900–7,209 cGy) for aloe/soap and 2,838 cGy (range 1,080–5,580 cGy) for soap.

Setting

Comprehensive Cancer Centre, University of Miami

Study Design

The study was a prospective, randomized, blinded clinical trial.

Measurement Instruments/Methods

  • Weekly skin scoring was performed with Radiation Therapy Oncology Group (RTOG) acute criteria. 
  • Other skin changes, such as texture, were recorded; there was no description of how these were assessed or measured.

Results

The only significant difference found was delayed time to observation of a skin change with aloe in those with a cumulative dose greater than 2,700 cGy (p = 0.01).

Conclusions

No clear benefit of aloe vera was demonstrated.

Limitations

  • It was unclear if all assessments were made at the same dose intervals or only once weekly.
  • Clinicians could order supplemental skin products as needed based on scoring severity of skin reactions. It was not possible to determine if the effect was related to aloe or other products.
  • There was no documentation of skin reactions other than erythema or start to skin changes.
  • No measures were described for the only significant finding.
  • Patients were assessed weekly using RTOG, but no RTOG scores data were provided.
  • The research question was “would aloe/soap decrease the incidence of skin reactions,” but the study was designed to assess delay to erythema. Data were not provided regarding overall incidence.
  • There was a wide range of doses.
  • Study conclusions stated were not supported by any data.
  • The author stated the study was double-blind; however no control product was identified or discussed.