Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
NCT05079763

Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Led by University of the Philippines · Updated on 2026-01-12

54

Participants Needed

1

Research Sites

382 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Histopathologic diagnosis of breast carcinoma
  • Completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant)
  • Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy
Not Eligible

You will not qualify if you...

  • Pregnant or lactating
  • History of any other malignancy
  • History of mediastinal or thoracic irradiation
  • Current bilateral synchronous breast carcinoma
  • Diagnosis of metastases from breast cancer
  • Any skin lesion in the planned radiation field that is dermatologically or radiotherapeutically relevant
  • Clinically significant concomitant diseases such as connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction
  • Known hypersensitivity or reactions to components of the study treatments
  • Unable to provide informed consent or comply with skin care instructions

AI-Screening

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Trial Site Locations

Total: 1 location

1

Philippine General Hospital

Manila, Philippines, 1000

Actively Recruiting

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Research Team

A

Aedrian A Abrilla, MD

CONTACT

C

Claudine Yap-Silva, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis | DecenTrialz