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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT07177560
Eligibility Criteria:
Inclusion Criteria
Age ≥18 years.
Histologically or cytologically confirmed colorectal or gastric cancer.
Planned capecitabine-based therapy (monotherapy or capecitabine plus oxaliplatin).
Planned starting capecitabine dose ≥2,000 mg/m²/day.
No prior systemic chemotherapy for the current malignancy.
Ability and willingness to attend weekly clinical assessments during treatment.
Written informed consent obtained.
Exclusion Criteria
Pre-existing dermatologic conditions affecting hands/feet (e.g., eczema, psoriasis) or peripheral neuropathy.
Sjögren's syndrome involving hands or feet.
Current or planned systemic NSAID use during capecitabine therapy.
Use of other HFS prophylaxis at baseline (e.g., topical NSAIDs other than diclofenac, pyridoxine).
Known hypersensitivity to diclofenac, aspirin, or other NSAIDs (e.g., history of asthma, urticaria, allergic reactions).
Planned initial capecitabine dose \<2,000 mg/m²/day.
Anticipated inability to comply with weekly follow-up assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07177560
Study Brief:
Protocol Section:
NCT07177560