Laser Therapy for the Management of Radiation Dermatitis

NCT01932073 | Completed

• 1 other identifier: 13.43/onco13.05
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Keywords

Radiation; dermatitis; radiodermatitis; radiotherapy induced; skin reactions; low level laser therapy; breast cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Quality of Life

  3 months (during radiation therapy and one month after)

• Impact of Radiation Dermatitis

  3 months (during radiation therapy and one month after)

• Satisfaction with therapy

  3 months (during radiation therapy and one month after)

Other Outcomes (1)

• Moist desquamation

  6.5 weeks (during radiation therapy)

Study Arms (2)

Control Group

NO INTERVENTION

Receives institutional skin care protocol

Treatment Group

EXPERIMENTAL

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

Device: Low-Level Laser Therapy

Interventions

Low-Level Laser Therapy DEVICE

Low-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful

Treatment Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Jessa Hospital - Oncology department

Hasselt, B-3500, Belgium

Location

MeSH Terms

Conditions

Radiodermatitis; Dermatitis; Breast Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Jeroen Mebis, MD, PhD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

BE (1)