Clinical Trial: Laser Therapy for the Management of Radiation Dermatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Low-Level Laser Therapy for the Management of Radiation Dermatitis: A Pilot Study in Breast Cancer Patients

Brief Summary:

Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes.

LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.


Detailed Summary:
Sponsor: Hasselt University

Current Primary Outcome:

  • Radiation Dermatitis Grade [ Time Frame: 3 months (during radiation therapy and one month after) ]
    objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC).
  • Radiation Dermatitis Assessment [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
  • Pain [ Time Frame: 3 months (during radiation therapy and one month after) ]
    evaluation of pain using a visual analogue scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of Life [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Health-related quality of life measure specific to skin diseases (Skindex-16)
  • Impact of Radiation Dermatitis [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Self-report on the impact of radiation dermatitis on daily activities
  • Satisfaction with therapy [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Self-report on the efficacy of and the global satisfaction with the management of radiation dermatitis


Original Secondary Outcome: Same as current

Information By: Hasselt University

Dates:
Date Received: August 27, 2013
Date Started: August 2013
Date Completion:
Last Updated: December 3, 2014
Last Verified: December 2014