Clinical trial NCT02443493: Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients
Official title: Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2015-05-13
Enrollment: 139
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
* 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:

* Previous irradiation to the same breast
* 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)

Primary outcomes:
measure: Radiation Dermatitis Grade
timeFrame: day 1
measure: Radiation Dermatitis Grade
timeFrame: day 20
measure: Radiation Dermatitis Grade
timeFrame: day 33
measure: Radiation Dermatitis Grade
timeFrame: day 40
measure: Radiation Dermatitis Grade
timeFrame: day 54
measure: Radiation Dermatitis Assessment
timeFrame: day 1
measure: Radiation Dermatitis Assessment
timeFrame: day 20
measure: Radiation Dermatitis Assessment
timeFrame: day 33
measure: Radiation Dermatitis Assessment
timeFrame: day 40
measure: Radiation Dermatitis Assessment
timeFrame: day 54
measure: Objective measurement of trans epidermal water loss of the skin
timeFrame: day 1
measure: Objective measurement of trans epidermal water loss of the skin
timeFrame: day 20
measure: Objective measurement of trans epidermal water loss of the skin
timeFrame: day 33
measure: Objective measurement of trans epidermal water loss of the skin
timeFrame: day 40
measure: Objective measurement of trans epidermal water loss of the skin
timeFrame: day 54
measure: Objective measurement of the skin hydration
timeFrame: day 1
measure: Objective measurement of the skin hydration
timeFrame: day 20
measure: Objective measurement of the skin hydration
timeFrame: day 33
measure: Objective measurement of the skin hydration
timeFrame: day 40
measure: Objective measurement of trans epidermal water loss of the skin
timeFrame: day 54
measure: Objective measurement of degree of erythema of the skin
timeFrame: day 1
measure: Objective measurement of degree of erythema of the skin
timeFrame: day 20
measure: Objective measurement of degree of erythema of the skin
timeFrame: day 33
measure: Objective measurement of degree of erythema of the skin
timeFrame: day 40
measure: Objective measurement of degree of erythema of the skin
timeFrame: day 54
measure: Analyze the skin cytokine content of the irradiated and non-irradiated breast
timeFrame: day 1
measure: Analyze the skin cytokine content of the irradiated and non-irradiated breast
timeFrame: day 20
measure: Analyze the skin cytokine content of the irradiated and non-irradiated breast
timeFrame: day 33
measure: Analyze the skin cytokine content of the irradiated and non-irradiated breast
timeFrame: day 40
measure: Analyze the skin cytokine content of the irradiated and non-irradiated breast
timeFrame: day 54
Secondary outcomes:
measure: Pain
timeFrame: day 1
measure: Pain
timeFrame: day 20
measure: Pain
timeFrame: day 33
measure: Pain
timeFrame: day 40
measure: Pain
timeFrame: day 54
measure: Quality of life
timeFrame: day 1
measure: Quality of life
timeFrame: day 20
measure: Quality of life
timeFrame: day 33
measure: Quality of life
timeFrame: day 40
measure: Quality of life
timeFrame: day 54
measure: Satisfaction with therapy
timeFrame: day 1
measure: Satisfaction with therapy
timeFrame: day 20
measure: Satisfaction with therapy
timeFrame: day 33
measure: Satisfaction with therapy
timeFrame: day 40
measure: Satisfaction with therapy
timeFrame: day 54
measure: moist desquamation
timeFrame: day 1
measure: moist desquamation
timeFrame: day 20
measure: moist desquamation
timeFrame: day 33
measure: moist desquamation
timeFrame: day 40
measure: moist desquamation
timeFrame: day 54
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital - Oncology department
Study officials:
affiliation: Universiteit Hasselt/ Jessa ziekenhuis
name: Jeroen Mebis, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: