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Protocol Paper: A Randomized Trial of 2 Creams in the Skin Care of Patients Receiving Radiation Therapy for Breast Cancer in the Tropics

Heyer, Elizabeth BNSc; Smyth, Wendy PhD; Laffin, Nadine BNSc; Gardner, Anne PhD

doi: 10.1097/NCC.0000000000000175
Articles: Online Only

Background: Nurses working in a northern Australia Radiation Therapy Unit advise all patients undergoing radiation therapy to use a readily available nonprescription moisturizing cream to minimize the severity of radiation skin reactions. However, patients report that the cream is thick and difficult to use in the humid tropical climate, and nurses anecdotally suspect an increase in severe skin reactions during the summer months.

Objective: This article presents the protocol for a randomized controlled trial that addressed a lack of evidence pertaining to the use of topical creams to prevent acute radiation skin reactions in a tropical climate.

Methods: Two skin care creams were used in the trial. The trial’s primary outcome measure was the incidence of moist desquamation during treatment and 1 month after treatment completion. The secondary outcome was the participants’ acceptance of the allocated cream at similar time points.

Results: Recruitment to the trial has been completed. Findings of the research will be reported in a separate publication.

Conclusions: This article presents the protocol for a randomized controlled trial that addresses a lack of evidence pertaining to the use of topical creams to prevent acute radiation skin reactions in a tropical climate.

Implications for Practice: This protocol can be adapted by other researchers conducting practice-based research.

Author Affiliations: Cancer Clinical Trials (Ms Heyer) and Radiation Therapy Unit (Ms Laffin), Townsville Cancer Centre, Townsville Hospital; Tropical Health Research Unit for Nursing and Midwifery Practice, Townsville Hospital and Health Service, and School of Nursing, Midwifery and Nutrition, James Cook University (Dr Smyth, Ms Heyer and Ms Laffin); and School of Nursing, Midwifery and Nutrition, James Cook University (Dr Smyth), Townsville, Queensland; and School of Nursing, Midwifery and Paramedicine (Signadou Campus), Australian Catholic University, Australian Capital Territory (Prof Gardner), Australia.

Trial Registration: www.ANZCTR.org.au/ACTRN12612000784819

Authors’ contributions: All authors were involved in the conception and design of the study. Ms Laffin, Dr Smyth, and Ms Heyer recruited participants and assisted in data collection. Prof Gardner randomized participants. All authors participated in writing the manuscript and have given approval of the version to be published.

The randomized controlled trial received funding from Townsville Hospital and Health Service Private Practice Research and Education Trust Fund (2009, 2010, 2011) and a Queensland Health Nursing and Midwifery Research Grant (2009).

The authors have no conflicts of interest to disclose.

Correspondence: Wendy Smyth, PhD, Tropical Health Research Unit for Nursing and Midwifery Practice, IMB 105, the Townsville Hospital, PO Box 670, Townsville, Queensland, Australia 4814 (Wendy.Smyth@health.qld.gov.au).

Accepted for publication May 26, 2014.

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