Back to resultsLaser Therapy for the Management of Radiation Dermatitis (DERMIS)
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Low-Level Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Dermatitis focused on measuring Radiation, dermatitis, radiodermatitis, radiotherapy induced, skin reactions, low level laser therapy, breast cancer
Eligibility 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)
Sites / Locations
- Jessa Hospital - Oncology department
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Treatment Group
Arm Description
Receives institutional skin care protocol
Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy
Outcomes
Primary Outcome Measures
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).
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Pain
evaluation of pain using a visual analogue scale
Secondary Outcome Measures
Quality of Life
Health-related quality of life measure specific to skin diseases (Skindex-16)
Impact of Radiation Dermatitis
Self-report on the impact of radiation dermatitis on daily activities
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiation dermatitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01932073
Brief Title
Laser Therapy for the Management of Radiation Dermatitis
Acronym
DERMIS
Official Title
Low-Level Laser Therapy for the Management of Radiation Dermatitis: A Pilot Study in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
Keywords
Radiation, dermatitis, radiodermatitis, radiotherapy induced, skin reactions, low level laser therapy, breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Receives institutional skin care protocol
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy
Intervention Type
Device
Intervention Name(s)
Low-Level Laser Therapy
Intervention Description
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 Outcome Measure Information:
Title
Radiation Dermatitis Grade
Description
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).
Time Frame
3 months (during radiation therapy and one month after)
Title
Radiation Dermatitis Assessment
Description
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time Frame
3 months (during radiation therapy and one month after)
Title
Pain
Description
evaluation of pain using a visual analogue scale
Time Frame
3 months (during radiation therapy and one month after)
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Health-related quality of life measure specific to skin diseases (Skindex-16)
Time Frame
3 months (during radiation therapy and one month after)
Title
Impact of Radiation Dermatitis
Description
Self-report on the impact of radiation dermatitis on daily activities
Time Frame
3 months (during radiation therapy and one month after)
Title
Satisfaction with therapy
Description
Self-report on the efficacy of and the global satisfaction with the management of radiation dermatitis
Time Frame
3 months (during radiation therapy and one month after)
Other Pre-specified Outcome Measures:
Title
Moist desquamation
Description
Onset time of moist desquamation
Time Frame
6.5 weeks (during radiation therapy)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeroen Mebis, MD, PhD
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital - Oncology department
City
Hasselt
ZIP/Postal Code
B-3500
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Laser Therapy for the Management of Radiation Dermatitis
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