Bacterial cellulose-monolaurin hydrogel to prevent radiation skin damage after mastectomy
Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
This trial will test whether a bacterial cellulose-monolaurin hydrogel, compared with a placebo cream, can prevent severe acute radiation dermatitis in Filipino women receiving postmastectomy radiotherapy for breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | University of the Philippines Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Manila) |
| Trial ID | NCT05079763 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older with breast carcinoma who have completed mastectomy and chemotherapy and are scheduled for hypofractionated postmastectomy radiotherapy with ECOG performance status 0–1 and no contraindicating skin or systemic conditions.
Not a fit: Patients with metastatic disease, prior thoracic irradiation, bilateral synchronous breast cancer, relevant skin lesions in the radiation field, pregnancy or lactation, or significant uncontrolled comorbidities are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the hydrogel could reduce severe radiation skin reactions, helping patients complete planned therapy and improving quality of life.
How similar studies have performed: Topical and hydrogel-based approaches for ARD have shown mixed results in prior trials, and the specific use of bacterial cellulose-monolaurin is relatively novel and not yet validated in large studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Manila
- Philippine General Hospital — Manila, Philippines (Recruiting)
Study contacts
- Study coordinator: Aedrian A Abrilla, MD
- Email: aaabrilla@up.edu.ph
- Phone: +639363193980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.