Feasibility of a Randomized Controlled Trial of Light Therapy in Cancer Patients with InsomniaDev R1*, Delgado-Guay MO1, De La Cruz M1, Rhondali W2, Hui D1 and Bruera E1
- *Corresponding Author:
- Rony Dev DO
Department of Palliative Care and Rehabilitation Medicine
Unit 1414, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
E-mail: [email protected]
Received date: June 19, 2014; Accepted date: August 26, 2014; Published date: September 06, 2014
Citation: Dev R, Delgado-Guay MO, De La Cruz M, Rhondali W, Hui D, et al. (2014) Feasibility of a Randomized Controlled Trial of Light Therapy in Cancer Patients with Insomnia. J Palliat Care Med 4:183. doi: 10.4172/2165-7386.1000183
Copyright: © 2014 Dev R, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Purpose: The primary objective of our study was to compare bright light therapy versus dim red light for global sleep quality in palliative care patients with cancer.
Methods: The study was designed as a randomized, double blind, placebo controlled trial. Patients initiated blinded phase, either daily bright light versus red light placebo, from day 1 to day 14, then proceeded to an open label phase between day 15 to day 28.
Results: Of the 319 outpatients assessed for eligibility, 97 patients (30%) fulfilled criteria for the study. Of the 97 patients, only 12 patients (12%) enrolled in the study with the majority unwilling to participate or reported a lack of interest in light therapy. Only 4 patients (33%) completed the trial to the primary endpoint at 2 weeks.
Conclusion: At our institution, a randomized controlled trial examining bright light therapy, a potentially safe and effective non-pharmacological approach to treat sleep disturbances, was not feasible for palliative care patients with cancer. Future studies should be tailored to advanced cancer patients who are often frail and have a high symptom burden, incorporate alternative trial designs such as randomization without a placebo arm, and consider integration of home visits or assessment by phone calls to lessen the burden of participation in a clinical trial.