Actively Recruiting
Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
Led by University of the Philippines · Updated on 2026-01-12
54
Participants Needed
1
Research Sites
382 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potentially leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. Nevertheless, there remains no consensus on the appropriate intervention for ARD. This pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ARD among Filipinos with breast cancer up to four weeks after last radiotherapy session.
CONDITIONS
Official Title
Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Histopathologic diagnosis of breast carcinoma
- Completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant)
- Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy
You will not qualify if you...
- Pregnant or lactating
- History of any other malignancy
- History of mediastinal or thoracic irradiation
- Current bilateral synchronous breast carcinoma
- Diagnosis of metastases from breast cancer
- Any skin lesion in the planned radiation field that is dermatologically or radiotherapeutically relevant
- Clinically significant concomitant diseases such as connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction
- Known hypersensitivity or reactions to components of the study treatments
- Unable to provide informed consent or comply with skin care instructions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Philippine General Hospital
Manila, Philippines, 1000
Actively Recruiting
Research Team
A
Aedrian A Abrilla, MD
CONTACT
C
Claudine Yap-Silva, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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