Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

University of the Philippines

Status: Enrolling

Conditions: Acute Radiation Dermatitis

Treatments: Other: Bacterial cellulose-monolaurin hydrogel; Other: Placebo cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05079763

UPMREB 2021-140-01

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

Experimental arm

Experimental group

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

Treatment:

Other: Bacterial cellulose-monolaurin hydrogel

Placebo Arm

Placebo Comparator group

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

Treatment:

Other: Placebo cream