Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bacterial cellulose-monolaurin hydrogel, Placebo cream.
- Who it may be relevant to
- Registry conditions: Acute Radiation Dermatitis. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Philippines
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
Overview
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.
Interventions
- Other Bacterial cellulose-monolaurin hydrogel
Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water - Other Placebo cream
Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben
Primary outcome measures
- Incidence of high grade acute radiation dermatitis [Time frame: Baseline to Week 4 post-radiotherapy]
Secondary outcome measures (2)
- Distribution of participants in terms of ARD CTCAE grades [Time frame: Baseline to Week 4 post-radiotherapy]
- Patient-reported quality of life [Time frame: Baseline to Week 4 post-radiotherapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Philippines · 1 center
- Philippine General Hospital — Manila
Identifiers
NCT: NCT05079763 · UPMREB 2021-140-01