Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Radiation Dermatitis

Intervention / Treatment
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* Other: Bacterial cellulose-monolaurin hydrogel
* Other: Placebo cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>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<br>* Hydrogel containing Komagataeibacter bylines-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water<br>|
| Placebo Comparator: Placebo Arm<br>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<br>* Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARD, postmastectomy, breast cancer, breast adenocarcinoma