DERMIS: Laser Therapy for the Management of Radiation Dermatitis

Sponsor

Hasselt University (Other)

Overall Status

Completed

CT.gov ID

NCT01932073

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Dermatitis	Device: Low-Level Laser Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life [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 [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

Other Outcome Measures

Moist desquamation [6.5 weeks (during radiation therapy)]
Onset time of moist desquamation

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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)