Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Phase 2

• Conditions: Acute Radiation Dermatitis
• Interventions: Other: Bacterial cellulose-monolaurin hydrogel; Other: Placebo cream

• Registration Number: NCT05079763
• Lead Sponsor: University of the Philippines

Brief Summary

Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potebtxallt 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-15
• Primary Completion: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-16
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Bacterial cellulose-monolaurin hydrogel	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
Placebo Arm	Placebo cream	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Philippine General Hospital; 🇵🇭 Manila, Philippines