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Laser Therapy for the Management of Radiation Dermatitis (DERMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01932073
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. dr. Jeroen Mebis, Hasselt University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : August 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Moist desquamation [ Time Frame: 6.5 weeks (during radiation therapy) ]
    Onset time of moist desquamation


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932073


Locations
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Belgium
Jessa Hospital - Oncology department
Hasselt, Belgium, B-3500
Sponsors and Collaborators
Hasselt University
Investigators
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Principal Investigator: Jeroen Mebis, MD, PhD Jessa Hospital
More Information
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Responsible Party: Prof. dr. Jeroen Mebis, MD, PhD, Hasselt University
ClinicalTrials.gov Identifier: NCT01932073    
Other Study ID Numbers: 13.43/onco13.05
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by Prof. dr. Jeroen Mebis, Hasselt University:
Radiation
dermatitis
radiodermatitis
radiotherapy induced
 skin reactions
low level laser therapy
breast cancer
Additional relevant MeSH terms:
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Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries