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:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT02573766
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
3. Pain score \>/= 4 on a 0-10 numeric pain scale and/or grade 3 neuropathic symptoms according to the National Cancer Institute's 4 point grading scale.
4. Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician).
5. Patients must report neuropathic pain for a minimum of 3 months.
6. No plans to change pain medication regimen during the course of the study.
7. Off active chemotherapy treatment for minimum of 6 months.
8. Willing to come to MD Anderson for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of MDA main campus; or can participate in the therapy sessions from one of MDA's Regional Care Centers.
9. Patients who are 18 years of age or above
10. Patients who have a diagnosis of breast cancer.
Exclusion Criteria:
1. Patients who are taking any antipsychotic medications.
2. Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.
3. Patients who have ever been diagnosed with bipolar disorder or schizophrenia.
4. Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy.
5. Patients who have a history of head injury or who have known seizure activity.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02573766
Study Brief:
Protocol Section:
NCT02573766