Acute Radiation Dermatitis
Conditions
Keywords
ARD, postmastectomy, breast cancer, breast adenocarcinoma
Brief summary
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
OTHERBacterial cellulose-monolaurin hydrogel
Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
OTHERPlacebo cream
Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben
Sponsors
University of the Philippines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Bacterial cellulose-monolaurin hydrogel
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Philippines
Contacts
Backup ContactClaudine Yap-Silva, MD
Primary ContactAedrian A Abrilla, MD
Outcome results
None listed