Oral or Topical Catechins for Radiation Dermatitis

NCT07149506 | Enrolling By Invitation Phase 3 DMC

• 2 other identifiers: CEI-038-2025CI/HRAEB/024/2025
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiation Dermatitis Acute; Radiation Dermatitis; Fibrosis; Skin

Keywords

Catechins; Radiation Dermatitis

Outcome Measures

Primary Outcomes (2)

• Change in the incidence of chronic radiation fibrosis

  Chronic radiation dermatitis/fibrosis This condition is defined as an adverse skin reaction that occurs more than 90 days after the start of radiotherapy. It involves permanent structural changes to the skin, such as fibrosis and vascular atrophy. Fibrosis can increase the risk of poor wound healing, skin contractures, and pain. Radiation therapy oncology group (RTOG) scale The RTOG scale is a standardized tool used to grade late-stage radiation effects. For the purposes of this study, the presence of fibrosis is graded on an ordinal scale with a minimum value of 0 and a maximum value of 2. On this scale, a higher score indicates a worse outcome (more severe fibrosis).

  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

  The Radiation-Induced Skin Reaction Assessment Scale (RISRAS) measures the severity of skin reactions to radiotherapy. It combines a clinician's assessment of visible signs with the patient's self-reported symptoms. A higher score, with a maximum of 37.5 points, indicates a more severe reaction. Clinicians apply the RISRAS scale to assess the the severity of acute radiation dermatitis. The change from baseline will be compared between the catechin and placebo groups to determine the impact on symptom severity.

  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.

Secondary Outcomes (6)

• Incidence of Adverse Events

  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

  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

  Measurements are taken throughout radiotherapy, up to week 7, with additional assessments at 1 and 2 weeks after the radiotherapy period.

• Cosmetic Outcome

  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

  Measurements are taken throughout radiotherapy, up to week 7, with additional assessments at 1 and 2 weeks after the radiotherapy period.

Other Outcomes (2)

• Compare the efficacy of a topical epigallocatechin-3-gallate (EGCG) aerosol versus an oral epicatechin (Epi) capsule

  The efficacy comparison of topical epigallocatechin gallate versus oral epicatechin will be conducted at the following times: at baseline (before administration), at week 7, 1 week post-radiotherapy, and 2 weeks post-radiotherapy.

• Explore the 6-month event-free survival (EFS) of the study groups

  6 months after radiotherapy concludes.

Study Arms (8)

Oral epicatechin prevention group

EXPERIMENTAL

Oral epicatechin at a dose of 50 mg orally every 12 hours, starting from the start of radiotherapy, considering that one dose should be taken 2.5 hours before radiotherapy.

Other: Epicatechin

Oral placebo prevention group

PLACEBO COMPARATOR

Microcrystalline cellulose at a dose of 50 mg orally every 12 hours, starting from the start of radiotherapy, considering that one dose should be taken 2.5 hours before radiotherapy.

Other: Microcrystalline Cellulose NF (placebo)

Topical epigallocatechin-3 gallate (EGCG) prevention group

EXPERIMENTAL

EGCG 660 μmol/L solution will be applied 0.5mL/cm2, 3 times a day in the treatment area from the start of radiotherapy and up to 2 weeks after the end of radiotherapy.

Other: Epigallocatechin Gallate (EGCG)

Topical placebo prevention group

PLACEBO COMPARATOR

Application of 0.5 mL/cm2 of 0.9% saline solution to the treatment area, three times per day. This regimen should be followed from the onset of radiotherapy until two weeks post-radiotherapy.

Other: Saline (0.9% NaCl)

Oral epicatechin treatment group

EXPERIMENTAL

Oral epicatechin at a dose of 50 mg orally every 12 hours from the development of grade 1 radiodermatitis, considering that one should be taken 2.5 hours before radiotherapy.

Other: Epicatechin

Oral placebo treatment group

PLACEBO COMPARATOR

Microcrystalline cellulose at a dose of 50 mg orally every 12 hours, starting from the development of grade 1 radiodermatitis, considering that a dose should be taken 2.5 hours before radiotherapy.

Other: Microcrystalline Cellulose NF (placebo)

Topical EGCG treatment group

EXPERIMENTAL

A solution of epigallocatechin-3 gallate (EGCG) 660 μmol/L, 0.5 mL/cm2, will be applied 3 times a day to the area to be treated from the development of grade 1 radiodermatitis and up to 2 weeks after the end of radiotherapy.

Other: Epigallocatechin Gallate (EGCG)

Topical placebo treatment group

PLACEBO COMPARATOR

Application of 0.5 mL/cm2 of 0.9% saline solution to the treatment area, three times per day. This regimen should be followed from the development of grade 1 radiodermatitis until two weeks post-radiotherapy.

Other: Saline (0.9% NaCl)

Interventions

Epicatechin OTHER

A comparison will be made between oral catechin (epicatechin) from two approaches: a preventive approach and a therapeutic approach.

Oral epicatechin prevention group; Oral epicatechin treatment group

Epigallocatechin Gallate (EGCG) OTHER

A comparison will be made between topical catechin (EGCG) from two approaches: a preventive approach and a therapeutic approach.

Also known as: Epigallocatechin-3 Gallate

Topical EGCG treatment group; Topical epigallocatechin-3 gallate (EGCG) prevention group

Microcrystalline Cellulose NF (placebo) OTHER

A comparison will be made between oral placebo (microcrystalline cellulose) from two approaches: a preventive approach and a therapeutic approach.

Also known as: Placebo

Oral placebo prevention group; Oral placebo treatment group

Saline (0.9% NaCl) OTHER

A comparison will be made between topical placebo (0.9% saline solution) from two approaches: a preventive approach and a therapeutic approach.

Also known as: Placebo

Topical placebo prevention group; Topical placebo treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CARLOS FRANCISCO SAAVEDRA GARCIA: lead
• Universidad de Guanajuato: collaborator
• Hospital Regional de Alta Especialidad del Bajio: collaborator

Study Sites (1)

HRAEB

León, Guanajuato, 37544, Mexico

Location

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MeSH Terms

Conditions

Radiodermatitis; Fibrosis

Interventions

Catechin; epigallocatechin gallate; Sodium Chloride

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonoids; Chromones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Carmen Palacios, MD; PhD; MMSc; genetics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD) and supporting documents will be available immediately following publication of the manuscript reporting the primary results (Start Date: March 2027) and will remain accessible until March 2032 (End Date: March 2032).
• Access Criteria: De-identified IPD and supporting documents will be accessible to qualified researchers who provide a methodologically sound research proposal approved by an independent Data Access Committee (DAC). Requestors must also provide IRB/IEC approval for their proposed analysis and sign a Data Use Agreement (DUA) committing to data privacy, confidentiality, and use solely for the approved purpose. Requests should be submitted via email to comite.investigación@hraeb.gob.mx. Approved data will be transferred securely using encrypted methods

Locations

ME (1)