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Glucoacetobacter Xylinus-derived Cellulose Gel in the Prevention of Radiation Therapy-Induced High-Grade Acute Dermatitis among Filipino Patients with Breast Cancer: A Pilot Randomized Controlled Trial

PHRR220207-004317

Unspecified

Unspecified

Glucoacetobacter Xylinus-derived Cellulose Gel in the Prevention of Radiation Therapy-Induced High-Grade Acute Dermatitis among Filipino Patients with Breast Cancer: A Pilot Randomized Controlled Trial

We are implementing the research study entitled “GLUCOACETOBACTER XYLINUS- DERIVED CELLULOSE GEL IN THE PREVENTION OF RADIATION THERAPY- INDUCED HIGH-GRADE ACUTE DERMATITIS AMONG FILIPINO PATIENTS WITH BREAST CANCER: A PILOT RANDOMIZED CONTROLLED TRIAL” with the following objectives:

1. To compare the incidence of greater than CTCAE grade 2 radiation dermatitis between the treatment and the comparator group.

2. To compare the time to occurrence of maximum grade dermatitis in the treatment and comparator groups.

3. To evaluate the treatment group’s assessment of their skin condition and quality of life as compared to the b group.

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Non-communicable diseases
Start Date Duration in Months Target Completion Date Actual Completion Date
2021-09-20 8 2022-05-20 0000-00-00

Ongoing

Institution Classification Region LTO #
Philippine General Hospital None Philippines
Institution Region
Philippine General Hospital Philippines
Name E-Mail Institution and Institution Address
Soraya Elisse E. Escandor seescandor@up.edu.ph Philippine General Hospital, Taft, Manila
Name E-Mail Institution and Institution Address
Soraya Elisse E. Escandor seescandor@up.edu.ph Philippine General Hospital, Taft, Manila
Name Expertise Affiliation
Soraya Elisse E Escandor Dermatology Philippine General Hospital
Project Location Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board

Acute radiation dermatitis is a consequence of a number of factors, including endothelial cell changes, inflammation, epidermal cell apoptosis and necrosis, as well as reduced number and impairment of stem cells (Hymes et al., 2006). It has a profound effect on patients and the course of their therapy, as cutaneous discomfort leads to treatment interruptions and patient non-compliance to treatment protocols (Becker-Schiebe et al., 2011). Management differs across institutions and individual practitioners. Apart from topical corticosteroid use, there is a lack of evidence based recommendations for radiation dermatitis despite the multitude of studies on therapeutic approaches (Bolderston et al., 2006). Topical corticosteroids, however, have several adverse effects such as atrophy, hypopigmentation, hypertrichosis, exacerbation of skin infections and delayed wound healing (Hengge et al., 2006). Given this, further research on new therapies is warranted.

The general aim of this study is to determine the efficacy of a suspension from Gluconacetobacter xylinus in reducing the incidence of high grade radiation dermatitis in adult breast cancer patients receiving postmastectomy treatment. The specific objectives of the study are to: To compare the incidence of at least CTCAE grade 2 radiation dermatitis between the treatment and the vehicle group (mineral oil); time to occurrence of maximum grade dermatitis in the treatment and vehicle groups. To evaluate the treatment group’s assessment of their skin condition and quality of life as compared to the vehicle group.

Unspecified

Pending

  • Philippines

Clinical Trial

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60

60

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Adult (≥ 18yo) Filipino female patients whose ECOG Performance Status is 0 or 1, with a histopathologic diagnosis of unilateral breast cancer and have already underwent mastectomy and chemotherapy, neoadjuvant or adjuvantly. Such patients about to receive conventionally-fractionated, postmastectomy radiation therapy, seen at the PGH Cancer Institute - Division of Radiation Oncology and Department of Dermatology OPD will be recruited by the principal investigator (SEE) and co-investigators (BMC, MAA, KBC, AA). Recruited patients will be asked to sign a written informed consent containing objectives, rationale and methods of the study. Exclusion criteria for both treatment and vehicle patients will be as follows: 1. Skin lesions in the radiation area before start of radiation therapy 2. Other clinically significant concomitant disease states, distant metastases and concurrent or previous malignancies, or pregnancy or lactating patients as judged by the primary investigator 3. History of thoracic or mediastinal radiation 4. Bilateral breast cancer 5. Known allergies, hypersensitivity or reactions against one of the constituents of the products 6. Inability to consent or comply with instructions for skin care Patients can anytime withdraw from the study.

Interventional

PatchMed Cocogel

Randomized Control Trial, double-blind technique, on the use of PatchMed Cocogel versus comparator for prevention of high grade radiation dermatitis.

None

Randomized

Double Blind

Unspecified

Parallel

For the study, the minimum sample size of at least 54, 27 patients for the treatment group and 27 patients for the vehicle group, was calculated based on the n1 (vehicle)= 80% occurrence vs. n2 (intervention)= 40% occurrence. The two- tailed alpha of 0.05, power of 0.80 and allocation ratio of 1:1 were utilized. Anticipating a dropout rate of 10%, the study will aim to recruit at least n = 60 participants (Faul et al., 2007).

Phase II

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