Laser Therapy for the Management of Radiation Dermatitis

Not Applicable

Completed

• Conditions: Radiation Dermatitis
• Interventions: Device: Low-Level Laser Therapy

• Registration Number: NCT01932073
• Lead Sponsor: Hasselt University

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 Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Low-Level Laser Therapy	Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jessa Hospital - Oncology department; 🇧🇪 Hasselt, Belgium