Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients
NCT ID: NCT02443493
Last Updated: 2019-07-26
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
139 participants
INTERVENTIONAL
2015-04-30
2017-06-30
Brief Summary
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Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent pilot study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot study was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in breast cancer patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Treatment group
Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
Low-level laser
Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
radiotherapy
Control group
Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
sham laser
Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
radiotherapy
Interventions
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Low-level laser
Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
sham laser
Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
radiotherapy
Other Intervention Names
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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 therapy
* Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week)
* Signed informed consent
Exclusion Criteria
* Metastatic disease
* Concurrent chemotherapy
* Required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
FEMALE
No
Sponsors
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Jessa Hospital
OTHER
Hasselt University
OTHER
Responsible Party
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Prof. dr. Jeroen Mebis
prof. dr.
Principal Investigators
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Jeroen Mebis, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Universiteit Hasselt/ Jessa ziekenhuis
Locations
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Jessa Hospital - Oncology department
Hasselt, , Belgium
Countries
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Other Identifiers
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15.38/onco15.06
Identifier Type: -
Identifier Source: org_study_id
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