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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT02794493
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet the following criteria to be eligible for the study:
1. Histologically confirmed colorectal cancer or breast cancer, of which colorecta cancer is advanced or undergoing adjuvant therapy after radical resection and breast cancer is at the stage of recurrence or metastasis;
2. Level 1 or above HFS after receiving capecitabine as part of routine standard care;
3. Plan to receive capecitabine as part of routine more than 2 weeks;
4. ECOG performance status 0-2;
5. Life expectancy greater than or equal to 3 months;
6. No serious heart, liver, kidney and other important viscera dysfunction, as defined below:
* absolute neutrophil count greater than or equal to 1.5 x 10(9)/L
* platelet count greater than or equal to 100 x 10(9)/L
* hemoglobin greater than or equal to 9.0 g/dL
* total bilirubin less than or equal to 1.5 times the ULN
* AST/SGOT and ALT/SGPT less than or equal to 2.5 times the ULN (or less than or equal to 5 times the ULN if liver function abnormalities due to underlying malignancy)
* creatinine less than or equal to 1.5 times the ULN
* creatinine clearance greater than or equal to 60 ml/min (by Cockcroft-Gault)
7. Ability to cooperate with HFS grade evaluation, understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Subjects meeting any of the following criteria are ineligible for study entry:
1. Concurrent with level 1 or above peripheral neuropathy (such as diabetic neuropathy or chemotherapy induced peripheral neuropathy);
2. Other acute or chronic inflammatory conditions or infections of the hands or feet that would complicate safety, application of topical creams, or study endpoints;
3. Currently taking other treatment for PPE (including topical urea cream, pyridoxine, celecoxib, compound matrine injection and deproteinized calf blood extractive injection);
4. History of severe or uncontrolled organic disease or infection, such as heart, pulmonary or renal failure that cause the termination of chemotherapy;
5. Pregnant (positive pregnancy test) or nursing women;
6. Participating in other clinical trial currently or within 4 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02794493
Study Brief:
Protocol Section:
NCT02794493