Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05079763
Other study ID # UPMREB 2021-140-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2021
Est. completion date December 2022

Study information

Verified date October 2021
Source University of the Philippines
Contact Soraya Elisse Escandor, MD
Email seescandor@up.edu.ph
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potebtxallt 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date December 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bacterial cellulose-monolaurin hydrogel
Hydrogel containing Komagataeibacter bylines-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
Placebo cream
Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben

Locations

Country Name City State
Philippines Philippine General Hospital Manila

Sponsors (1)

Lead Sponsor Collaborator
University of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of high grade acute radiation dermatitis High-grade acute radiation dermatitis is defined as Common Terminology Criteria for Adverse Events (CTCAE) grade of at least 3 Baseline to Week 4 post-radiotherapy
Secondary Distribution of participants in terms of ARD CTCAE grades Distribution of participants across the ARD CTCAE grades (0-5) in the two interventions will be compared Baseline to Week 4 post-radiotherapy
Secondary Patient-reported quality of life Outcome will be assessed using the Skindex-16 (SD-16) questionnaire, administered on a weekly basis from baseline up to two weeks post-radiotherapy Baseline to Week 4 post-radiotherapy
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03394417 - StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients N/A