Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2028-12-31

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 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.

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Detailed Description

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Conditions

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Acute Radiation Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Bacterial cellulose-monolaurin hydrogel

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Bacterial cellulose-monolaurin hydrogel

Intervention Type OTHER

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

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

Group Type PLACEBO_COMPARATOR

Placebo cream

Intervention Type OTHER

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

Interventions

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Bacterial cellulose-monolaurin hydrogel

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

Intervention Type OTHER

Placebo cream

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No