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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT02381405
Eligibility Criteria:
Inclusion Criteria:
1. Patients with any combination of therapies including radiation therapy alone, chemotherapy alone, TKI alone, or any combination are eligible.
2. This includes patients with therapies including Xeloda (capecitabine), Camptosar (irinotecan) or 5-FU (fluorouracil) with cancer.
3. Patients who have been diagnosed with a CID CTCAE toxicity of grade 3 or higher
4. Patients must be at least 18 years of age.
5. ECOG performance status 0-2.
6. Patients must have diarrhea symptoms, judged secondary to the systemic therapy, combined systemic therapy, and/or radiation, and must be requiring loperamide or similar (Imodium®) for symptom management. For the purposes of this study, diarrhea will be defined as three or more loose or liquid stools per day or loose watery stool (greater volume of stool) that occur more frequently than usual and lasting for more than three days.
Exclusion Criteria:
1. ECOG performance status 3 or greater.
2. Pregnant and/or breast-feeding women
3. Pre-menopausal subjects as well as subjects with ovarian radiation or concomitant treatment with an LH-RH agonist/antagonist must have a negative pregnancy test and agree to use an adequate method of contraception as recommended by their treating physicians
4. Post-menopausal status is defined either by:
1. age ≥55 years and one year or more of amenorrhea,
2. age \<55 years and one year or more of amenorrhea with an estradiol assay \<20 pg/mL
3. bilateral oophorectomy
4. CID CTCAE grade 1 or 2 (not requiring Loperamide or similar)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02381405
Study Brief:
Protocol Section:
NCT02381405