Clinical trial · Interventional
Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacterial cellulose-monolaurin hydrogel | Other | — | UNRESOLVED |
| Placebo cream | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- 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
- interventionNames
- Other: Bacterial cellulose-monolaurin hydrogel
- type
- PLACEBO_COMPARATOR
- label
- Placebo Arm
- description
- 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
- interventionNames
- Other: Placebo cream
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available