Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT07149506
Eligibility Criteria:
Inclusion Criteria:
* 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:
1. Prevention cohort: No clinical evidence of dermatitis at the initiation of radiotherapy.
2. Treatment cohort: Development of grade 1 dermatitis during radiotherapy, with symptom onset within the last 3 days.
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07149506
Study Brief:
Protocol Section:
NCT07149506