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Completed

NCT Number: NCT01932073

Laser Therapy for the Management of Radiation Dermatitis

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital - Oncology department

Hasselt, B-3500, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Radiation Dermatitis Grade

    Time frame: 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).

  2. Radiation Dermatitis Assessment

    Time frame: 3 months (during radiation therapy and one month after)

    Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  3. Pain

    Time frame: 3 months (during radiation therapy and one month after)

    evaluation of pain using a visual analogue scale

Secondary outcomes

  1. Quality of Life

    Time frame: 3 months (during radiation therapy and one month after)

    Health-related quality of life measure specific to skin diseases (Skindex-16)

  2. Impact of Radiation Dermatitis

    Time frame: 3 months (during radiation therapy and one month after)

    Self-report on the impact of radiation dermatitis on daily activities

  3. Satisfaction with therapy

    Time frame: 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 outcomes

  1. Moist desquamation

    Time frame: 6.5 weeks (during radiation therapy)

    Onset time of moist desquamation

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study title

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

Acronym: DERMIS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 30, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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