Bacterial cellulose-monolaurin hydrogel to prevent radiation skin damage after mastectomy

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 is a pilot, two-arm randomized trial comparing a bacterial cellulose-monolaurin hydrogel to a placebo cream in preventing high-grade acute radiation dermatitis (ARD) after hypofractionated postmastectomy radiotherapy. Eligible participants are adult Filipino women with histologically confirmed breast carcinoma who have completed mastectomy and chemotherapy and have ECOG 0–1. The primary outcome is development of high-grade ARD up to four weeks after the last radiotherapy session, with regular clinical skin assessments during and after radiation. The trial is conducted at the Philippine General Hospital with on-site application or instruction for topical use and follow-up visits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female sex at birth
* Age at least 18 years at the time of invitation
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
* With histopathologic diagnosis of breast carcinoma
* Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
* Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy

Exclusion Criteria:

* Pregnant or lactating
* With concurrent or previous history of any malignancy
* With history of mediastinal or thoracic irradiation
* With current bilateral synchronous breast carcinoma
* With diagnosis of metastases from any form of breast cancer
* With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
* With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)
* With known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions
* Inability to personally provide informed consent or to personally comply with skin care instructions

Where it's running

• Philippine General Hospital
  Manila, Philippines Recruiting

Study contacts

• Study coordinator: Aedrian A Abrilla, MD
• Email: aaabrilla@up.edu.ph
• Phone: +639363193980

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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.