Laser Therapy for the Management of Radiation Dermatitis

Radiation Dermatitis Clinical Trial

— DERMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932073
• Other study ID #: 13.43/onco13.05
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: December 3, 2014
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Radiation Dermatitis
• Radiodermatitis

Intervention

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

Locations

Country	Name	City	State
Belgium	Jessa Hospital - Oncology department	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moist desquamation	Onset time of moist desquamation	6.5 weeks (during radiation therapy)	No
Primary	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)	No
Primary	Radiation Dermatitis Assessment	Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	3 months (during radiation therapy and one month after)	No
Primary	Pain	evaluation of pain using a visual analogue scale	3 months (during radiation therapy and one month after)	No
Secondary	Quality of Life	Health-related quality of life measure specific to skin diseases (Skindex-16)	3 months (during radiation therapy and one month after)	No
Secondary	Impact of Radiation Dermatitis	Self-report on the impact of radiation dermatitis on daily activities	3 months (during radiation therapy and one month after)	No
Secondary	Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiation dermatitis	3 months (during radiation therapy and one month after)	No