Oral or Topical Catechins for Radiation Dermatitis

Официальное название

Efficacy of Oral or Topical Catechins vs. Placebo as an Adjuvant for the Prevention and Management of Radiation Dermatitis in Oncology Patients: a Randomized Trial

Обзор

Introduction Radiation-induced dermatitis (RID), which includes both acute and chronic forms, affects up to 95% of patients undergoing radiation therapy. Despite its high incidence, there are currently no validated prevention and management recommendations specifically for the mexican population. Catechins, particularly epigallocatechin gallate and epicatechin, are emerging as a promising and readily accessible therapeutic option for radiation damage in skin and other organs, including conditions like esophagitis, intestinal injury, and mucositis. Objective This study aims to evaluate the utility of oral or topical catechins in preventing and managing acute and chronic radiation-induced dermatitis in cancer patients, comparing their effectiveness against standard treatment. Material and Methods This will be a randomized, double-blind, phase III clinical trial with a longitudinal and comparative design. Patients will be allocated into two primary study groups: prevention (n=81) and treatment (n=81). Each group will be further divided into four treatment arms: Epigallocatechin gallate (experimental aerosol) Epicatechin (experimental capsule) Saline control arm (aerosol) Microcrystalline cellulose excipient control arm (capsule) All participants across all groups will receive standard care. Study endpoints will include the assessment of utility, toxicity, quality of life, and cosmesis, using various validated scales and scores. Ethics This study adheres to the principles outlined in the Helsinki Declaration (2024), the Nuremberg Code, and Mexico's General Health Law on health research. Given the wide therapeutic margin of the interventions, the study is classified as minimal risk. Statistical Analysis To evaluate the efficacy of the intervention (specifically, the change in the risk of dermatitis and fibrosis), we will calculate the hazard ratio using Cox regression and compare it with the Log-Rank test. Additionally, both fixed and random effects models will be performed and compared using the likelihood ratio test.

Вмешательства

• Другое Epicatechin
  A comparison will be made between oral catechin (epicatechin) from two approaches: a preventive approach and a therapeutic approach.
• Другое Epigallocatechin Gallate (EGCG)
  A comparison will be made between topical catechin (EGCG) from two approaches: a preventive approach and a therapeutic approach.
• Другое Microcrystalline Cellulose NF (placebo)
  A comparison will be made between oral placebo (microcrystalline cellulose) from two approaches: a preventive approach and a therapeutic approach.
• Другое Saline (0.9% NaCl)
  A comparison will be made between topical placebo (0.9% saline solution) from two approaches: a preventive approach and a therapeutic approach.

Первичные конечные точки

• Change in the incidence of chronic radiation fibrosis [Срок оценки: A baseline RTOG scale evaluation is performed before the placebo or catechins treatment begins. Following treatment, primary measurements for fibrosis are taken during follow-up visits at 3 and 6 months post-radiotherapy.]
• Change in the radiation-induced skin reaction assessment scale (RISRAS) score [Срок оценки: A baseline RISRAS scale evaluation is performed before the placebo or catechins treatment begins. Subsequent measurements are then taken up to week 7 during radiotherapy, and at 1 week and 2 weeks post-radiotherapy.]

Вторичные конечные точки (6)

• Incidence of Adverse Events [Срок оценки: A baseline CTCAE v5.0 scale evaluation is performed before the placebo or catechins treatment begins. Subsequent evaluations are then conducted up to week 7 during radiotherapy and again at 3 months post-radiotherapy.]
• Dermatological Quality of Life [Срок оценки: The measurement will be taken at baseline (before the placebo or catechins treatment begins), weekly up to week 7 during radiotherapy, and at 3 and 6 months post-radiotherapy.]
• Cumulative radiation dose at onset of grade ≥2 dermatitis [Срок оценки: Measurements are taken throughout radiotherapy, up to week 7, with additional assessments at 1 and 2 weeks after the radiotherapy period.]
• Cosmetic Outcome [Срок оценки: Photographs will be taken at three key points: Baseline, before the placebo or catechins treatment begins. During radiotherapy, specifically at weeks 1 and 3 of treatment. Post-radiotherapy, at both 3 and 6 months after treatment.]
• Duration of grade ≥2 dermatitis [Срок оценки: Measurements are taken throughout radiotherapy, up to week 7, with additional assessments at 1 and 2 weeks after the radiotherapy period.]
• Percentage of Affected Skin Area by Radiation Dermatitis [Срок оценки: Baseline, week 1, and week 3 of radiotherapy.]

Критерии участия

Критерии включения

• Histopathologically confirmed diagnosis of cancer.
• Complete blood count, blood chemistry, and liver function tests within normal ranges.
• Availability of an anatomopathological report.
• Aged between 18 and 75 years.
• Karnofsky performance status (KPS) score > 60 or an Eastern Cooperative Oncology Group (ECOG) performance status score < 3.
• Candidate for radiotherapy with a prescribed dose of ≥40 Gy or its biological equivalent (EQD2).
• Must provide written informed consent to participate in the study.
• Must be able to swallow capsules.
• Must meet one of the following cohort-specific criteria:

• Prevention cohort: No clinical evidence of dermatitis at the initiation of radiotherapy.
• Treatment cohort: Development of grade 1 dermatitis during radiotherapy, with symptom onset within the last 3 days.

Критерии исключения

• Pregnant or lactating.
• Immunocompromised or on chronic therapy with immunosuppressive or immunomodulatory medications.
• History of chemical burns or unhealed wounds in the intended radiotherapy treatment area.
• Current diagnosis of skin cancer or a known diagnosis of a DNA repair gene defect.
• Prior radiotherapy to the area currently being treated.
• Known allergy to any of the study compounds.
• Currently receiving treatment with bortezomib, sunitinib, ticagrelor, or other antithrombotic agents.

Withdrawal Criteria:

• Adherence to the study intervention is less than 80%.
• Withdrawal of consent.
• Suspension of their radiotherapy sessions secondary to an acute infectious disease or the need for hospitalization

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• HRAEB — León

Публикации

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Идентификаторы

NCT: NCT07149506 · CEI-038-2025 · CI/HRAEB/024/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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