Mepitel Film for Preventing Radiation Dermatitis in Breast Cancer Patients in Singapore

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, observational feasibility study will enroll 60 breast cancer patients divided into two cohorts: 30 receiving local breast radiotherapy and 30 receiving chest wall radiotherapy after mastectomy. The study aims to assess tolerability of Mepitel Film and its ability to prevent moderate to severe dermatitis (Grade ≥2), while also examining quality of life, patient satisfaction, and costs. Results will be compared with published Western data to account for the hot and humid tropical climate. Inclusion includes adults 21 and older undergoing specified RT regimens, with language support available. Exclusion criteria include prior RT to the planned treatment site, certain RT techniques, active dermatitis in the treatment area, and known adhesive or silicon allergies.

Why it matters

Who can join: the full rules

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's running

• National University Hospital
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Wee Yao Koh, MBBS — National University Hospital, Singapore
• Study coordinator: Shing Fung Lee, MBBS
• Email: leesf@nuhs.edu.sg
• Phone: +6567726392

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.