Mepitel Film Breast
Recruiting · NCT07729423 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
Primary Objective To examine the tolerability of Mepitel Film in the prevention of RD patients undergoing whole breast or chest wall RT in the hot and humid weather in Singapore Secondary Objectives To evaluate the incidence of acute radiation dermatitis, quality of life, satisfaction, and cost analysis of Mepitel Film use.
Who can take part
Age range
21 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age ≥ 21 years old (legal age of maturity in Singapore)
- Male or female
- Informed consent
- Patients have undergone a mastectomy with or without reconstruction or breast-conserving surgery.
- Histological confirmation of breast carcinoma (invasive or in situ carcinoma)
- Patients are scheduled to receive hypofractionated (40Gy in 15 daily fractions or 26Gy in 5 daily fractions) photon-based RT
- Patient treated with or without tissue the addition of equivalent bolus and/or boost.
- Can communicate in English or be aided by a translator.
Exclusion criteria
- Prior RT to any portion of the planned treatment site.
- Patients will receive partial breast external beam RT, proton beam therapy, or brachytherapy.
- Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area may make skin assessment for the study difficult per treating physician discretion.
- Known history of adhesive, tape or silicon allergy or sensitivity.
- Concomitant cytotoxic chemotherapy
- Bilateral breast pathology requiring concurrent bilateral breast or chest wall RT.
- Current inflammatory breast cancer or gross dermal involvement at initiation of RT.
- Patient has a Karnofsky Performance Status score \<60.
Where it is running
1 location listed.
- National University Hospital - Singapore, Singapore