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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01906008
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a pathologically proven diagnosis of CRC seen either at MD Anderson or LBJ.
2. Patients \> or = 18 years old.
3. Patients who qualify for oxaliplatin-based chemotherapy (in the adjuvant or metastatic setting) and are likely to receive at least 3 months of oxaliplatin.
4. Patients who speak English or Spanish (due to language options for the MDASI version being used in this study, we are only recruiting English-speaking or Spanish-speaking patients).
5. Patients with an NCI-CTCv4 sensory neuropathy score of 0.
6. Patients with adequate renal function (serum creatinine must be \< 1.5 times the upper limit of the institutional normal range) and no prior renal disease that in the opinion of the attending physician would make the patient ineligible to receive the study drug . Test results must be no more than 3 months old.
7. Patients with adequate hepatic function (total bilirubin must be \< 2.0 times the upper limit of the institutional normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be \< 3.0 times the upper limit of the institutional normal range). Test results must be no more than 3 months old.
8. Patients willing and able to review, understand, and provide written consent.
Exclusion Criteria:
1. Patients continuously taking any minocycline within the last 15 days. Patients who have conditions that potentially preclude use of minocycline as determined by the treating physician.
2. Patients continuously taking systemic steroids within the last 15 days.
3. Patients with autoimmune disorders (for example, systemic lupus erythematosus or rheumatoid arthritis), who have been treated in the last 3 years.
4. Patients who are pregnant; the absence of pregnancy will be confirmed by negative urine test.
5. Hypersensitivity to any tetracyclines, or a history of other allergies or drug reactions that in the treating physician's judgment make the patient inappropriate for this study.
6. Patients receiving vitamin K antagonist (warfarin).
7. Patients with a BMI \>40 (Obese Class III criteria).
8. Patients who will receive cetuximab or other targeted therapy where physicians may use topical doxycycline to reduce the rash associated with therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01906008
Study Brief:
Protocol Section:
NCT01906008