Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Radiation Dermatitis
• Intervention / Treatment: Other: Placebo cream; Other: Bacterial cellulose-monolaurin hydrogel

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aedrian A Abrilla, MD; Phone Number: +639363193980; Email: aaabrilla@up.edu.ph
• Study Contact Backup: Name: Claudine Yap-Silva, MD; Email: cysilva@up.edu.ph

Study Locations

• Philippines
  • Manila, Philippines, 1000
    • Recruiting
    • Philippine General Hospital
    • Contact: Claudine Yap-Silva, MD; Email: cysilva@up.edu.ph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; Application of bacterial cellulose-monolaurin hydrogel in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan	Other: Bacterial cellulose-monolaurin hydrogel; Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
Placebo Comparator: Placebo Arm; Application of placebo cream in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan	Other: Placebo cream; Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of high grade acute radiation dermatitis	High-grade acute radiation dermatitis is defined as Common Terminology Criteria for Adverse Events (CTCAE) grade of at least 3	Baseline to Week 4 post-radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of participants in terms of ARD CTCAE grades	Distribution of participants across the ARD CTCAE grades (0-5) in the two interventions will be compared	Baseline to Week 4 post-radiotherapy
Patient-reported quality of life	Outcome will be assessed using the Skindex-16 (SD-16) questionnaire, administered on a weekly basis from baseline up to two weeks post-radiotherapy	Baseline to Week 4 post-radiotherapy

Collaborators and Investigators

• Sponsor: University of the Philippines

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; breast adenocarcinoma; ARD; postmastectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Monolaurin
• Other Study ID Numbers: UPMREB 2021-140-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No