Recruiting

Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

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…

ClinicalTrials.gov IDNCT05079763

PhaseNA

Enrollment54

SponsorUniversity of the Philippines

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Acute Radiation Dermatitis

About this study

Interventions

Other: Bacterial cellulose-monolaurin hydrogel — Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
Other: Placebo cream — Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben

Primary outcomes

Incidence of high grade acute radiation dermatitis (Baseline to Week 4 post-radiotherapy)

Eligibility information

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

Study locations

Philippine General Hospital, Manila, 1000 Philippines

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.