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Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients

NCT02443493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2019-07-26

No results posted yet for this study

Summary

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent pilot study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot study was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in breast cancer patients.

Conditions

Interventions

DEVICE

Low-level laser

Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.

DEVICE

sham laser

Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.

RADIATION

radiotherapy

Sponsors & Collaborators

  • Jessa Hospital

    collaborator OTHER

  • Hasselt University

    lead OTHER

Principal Investigators

  • Jeroen Mebis, prof. dr. · Universiteit Hasselt/ Jessa ziekenhuis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02443493 on ClinicalTrials.gov