NCT07729423

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
33mo left

Started Nov 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Nov 2025Jun 2029

Study Start

First participant enrolled

November 12, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

July 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Breast CancerRadiation Dermatitis

Keywords

dermatitisradiation dermatitisbreast cancerMepitel Film

Outcome Measures

Primary Outcomes (1)

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

    From first day RT to the 2 weeks post RT

Secondary Outcomes (12)

  • 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

    From enrollment to the 3 months post RT

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

    From enrollment to the 2 weeks post RT

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

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

  • HCP reported SSA

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

  • Incidence of moist desquamation assessed by HCP

    From enrollment to 2 weeks post RT

  • +7 more secondary outcomes

Study Arms (2)

Patients with breast radiation

Patients with chest wall radiation

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

National University Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsRadiodermatitisDermatitis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and Injuries

Study Officials

  • Wee Yao Koh, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shing Fung Lee, MBBS

CONTACT

+6567726392leesf@nuhs.edu.sg

Qian Yee Chai, BSc

CONTACT

+6567723077queenie_qy_chai@nuhs.edu.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

November 12, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

July 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)