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Recruiting

NCT Number: NCT07729423

Mepitel Film Breast

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.

Recruiting

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital

Singapore

Location status: Recruiting

Location contact

Balamurugan A Vellayappan, MBBS

SUB_INVESTIGATOR

Fatin Aliyah Binte Hussin, BSc

CONTACT

[email protected]

+6567723079

Kiat Huat Ooi, MBBS

SUB_INVESTIGATOR

Pui Lam Yip, MBBS

SUB_INVESTIGATOR

Qian Yee Chai, BSc

CONTACT

[email protected]

+6567723077

Shing Fung Lee, MBBS

SUB_INVESTIGATOR

Teng Hwee Tan, MBBS

SUB_INVESTIGATOR

Wee Yao Koh, MBBS

PRINCIPAL_INVESTIGATOR

Wei Tsau David Chia, MBBS

SUB_INVESTIGATOR

Weishan Ivy Ng, MBBS

SUB_INVESTIGATOR

Yaling Vicky Koh, MBBS

SUB_INVESTIGATOR

Yiat Horng Leong, MBBS

SUB_INVESTIGATOR

About this study

This prospective, observational feasibility study will enroll 60 breast cancer patients, divided into two cohorts: 30 receiving local breast RT and 30 receiving chest wall RT post-mastectomy. We hypothesize that Mepitel Film will be well-tolerated and effective in preventing severe RD (Grade ≥2) in this population, with results compared to published data from Western countries. Previous randomized controlled trials (RCTs) conducted in regions with low humidity and cool temperatures have raised concerns about film adherence and cost in tropical climates. Therefore, assessing the efficacy of Mepitel Film in a hot and humid environment is warranted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada

    Time frame: From first day RT to the 2 weeks post RT

Secondary outcomes

  1. Frequency and severity of patient reported pruritis in SSA and RISRAS related to use of Mepitel Film when compared with the data from the RCT in Ontario, Canada

    Time frame: From enrollment to the 3 months post RT

  2. Incidence of ARD grades 2 to 3, as defined by the CTCAE V5 assessed by HCP

    Time frame: From enrollment to the 2 weeks post RT

  3. Patient-reported skin-related symptoms using the Skin Symptom Assessment (SSA)

    Time frame: From enrollment to the end of study (2 years post RT)

  4. HCP reported SSA

    Time frame: From enrollment to the end of study (2 years post RT)

  5. Incidence of moist desquamation assessed by HCP

    Time frame: From enrollment to 2 weeks post RT

  6. Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by patient and HCP

    Time frame: From enrollment to 3 months post RT

  7. Blinded HCP-assessed mRISRAS scores from blinded grading of photographs taken at the end of RT

    Time frame: End of RT treatment

  8. Photographs with EORTC-BCRS

    Time frame: From enrollment to the end of study (2 years post RT)

  9. Patient-reported QOL using the Skindex-16

    Time frame: From enrollment to the end of study (2 years post RT)

  10. Patient satisfaction with Mepitel Film as assessed by the patient satisfaction questionnaire

    Time frame: 3 months post RT

  11. HCP satisfaction with Mepitel Film as assessed by the HCP satisfaction questionnaire

    Time frame: 3 months post RT

  12. Cost analysis of Mepitel Film for prevention of RD (evaluation and calculation of Mepitel Film usage and financial cost using Film Integrity Assessment)

    Time frame: From first day RT to the 2 weeks post RT

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Yee Chai, BSc

CONTACT

[email protected]

+6567723077

Shing Fung Lee, MBBS

CONTACT

[email protected]

+6567726392

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • Molnlycke Health Care AB

Registry information

Official study title

The Tolerability of Mepitel Film for the Prevention of Radiation Dermatitis in Breast Cancer Patients in Hot Weather: A Feasibility Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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