Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Sponsor

University of the Philippines (Other)

Overall Status

Recruiting

CT.gov ID

NCT05079763

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Radiation Dermatitis	Other: Bacterial cellulose-monolaurin hydrogel Other: Placebo cream	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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 bylines-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

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 bylines-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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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