Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic process in the skin which can lead to increased risk of malignancy, poor wound healing, pain and limitation of movement, and permanent loss of skin appendages with hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and quality of life issues. Advances in laser therapy has led to the use of fractional laser treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling in patients affected by chronic radiation injury. Understanding and correcting this underlying fibrotic process can help restore normal skin functions in patients affected with chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology such as scleroderma, morphea, or nephrogenic systemic fibrosis.
We propose to treat 22 patients with significant radiation induced fibrosis (RIF) and skin changes. Each patient will receive fractional treatment (FLT) using the Lumenis Ultrapulse Carbon Dioxide (CO2) laser as well as control (no treatment) randomized to site. Patient age, type of cancer, method/dosage of radiation, latency between radiation treatment and start of study, and characteristics of skin changes will be recorded, including fibrosis surface area, depth, color, and compliance. Assessments will be conducted before each treatment, after each treatment, and 3-12 months after the last treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
Patient will be treated with fractional laser treatment over the areas with fibrosis.
Patient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment.
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, United States
Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites
The primary end point is % reduction of the fibrosis surface area compared to control sites at 6-12 months.
Time frame: 6-12 months
Adverse events
Measurement adverse events (infection, scarring, ulceration, excessive bleeding, poor wound healing)
Time frame: 2 years
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