Laser Therapy for the Management of Radiation Dermatitis (DERMIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Device: Low-Level Laser Therapy

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, B-3500
    • Jessa Hospital - Oncology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma
• Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
• Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
• Provide signed informed consent

Exclusion Criteria:

• Previous irradiation to the same breast
• Metastatic disease
• Mastectomy surgery
• Concurrent chemo-radiotherapy
• Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Receives institutional skin care protocol
Experimental: Treatment Group; Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy	Device: Low-Level Laser Therapy; Low-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dermatitis Grade	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).	3 months (during radiation therapy and one month after)
Radiation Dermatitis Assessment	Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	3 months (during radiation therapy and one month after)
Pain	evaluation of pain using a visual analogue scale	3 months (during radiation therapy and one month after)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moist desquamation	Onset time of moist desquamation	6.5 weeks (during radiation therapy)

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Jeroen Mebis, MD, PhD, Jessa Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: breast cancer; low level laser therapy; skin reactions; Radiation; dermatitis; radiodermatitis; radiotherapy induced
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: 13.43/onco13.05