Laser Therapy for the Management of Radiation Dermatitis (DERMIS)

Hasselt University

Status

Completed

Conditions

Radiation Dermatitis

Treatments

Device: Low-Level Laser Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01932073

13.43/onco13.05

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

Female

Volunteers

No Healthy Volunteers

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)