Laser Therapy for the Management of Radiation Dermatitis
NCT ID: NCT01932073
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2013-08-31
2014-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Receives institutional skin care protocol
No interventions assigned to this group
Treatment Group
Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
FEMALE
No
Sponsors
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Hasselt University
OTHER
Responsible Party
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Prof. dr. Jeroen Mebis
MD, PhD
Principal Investigators
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Jeroen Mebis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Jessa Hospital
Locations
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Jessa Hospital - Oncology department
Hasselt, , Belgium
Countries
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Other Identifiers
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13.43/onco13.05
Identifier Type: -
Identifier Source: org_study_id