Status:
ENROLLING_BY_INVITATION
Oral or Topical Catechins for Radiation Dermatitis
Lead Sponsor:
CARLOS FRANCISCO SAAVEDRA GARCIA
Collaborating Sponsors:
Universidad de Guanajuato
Hospital Regional de Alta Especialidad del Bajio
Conditions:
Radiation Dermatitis Acute
Radiation Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 currentl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT07149506
Start Date
September 1 2025
End Date
March 1 2027
Last Update
September 8 2025
Active Locations (1)
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1
HRAEB
León, Guanajuato, Mexico, 37544