Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

NCT05079763 | Recruiting

• 1 other identifier: UPMREB 2021-140-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Radiation Dermatitis

Keywords

ARD; postmastectomy; breast cancer; breast adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Distribution of participants in terms of ARD CTCAE grades

  Baseline to Week 4 post-radiotherapy

• Patient-reported quality of life

  Baseline to Week 4 post-radiotherapy

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Placebo Arm

PLACEBO COMPARATOR

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

Interventions

Placebo cream OTHER

Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben

Placebo Arm

Bacterial cellulose-monolaurin hydrogel OTHER

Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water

Experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines: lead

Study Sites (1)

Philippine General Hospital

Manila, 1000, Philippines

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Aedrian A Abrilla, MD

CONTACT

+639363193980; aaabrilla@up.edu.ph

Claudine Yap-Silva, MD

CONTACT

cysilva@up.edu.ph

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Bacterial cellulose-monolaurin hydrogel

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

PH (1)