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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT03571334
Eligibility Criteria:
Inclusion Criteria:
1. Been diagnosed with breast cancer and undergone treatment with taxane based chemotherapeutic agents. Patients with metastatic and non metastatic disease are eligible.
2. Have neuropathic pain with onset within 6 months of chemotherapy
3. Must score \>4 on DN4 scale, a scale with high specificity and sensitivity for differentiating neuropathic pain from somatic and nociceptive pain
4. Age \>18 years, male and/or female
5. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
1. End Stage Renal Disease patients on Hemodialysis
2. Female participants who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or intend to become pregnant within 6 months.
3. History of peripheral neuropathy attributed to any cause other than chemotherapy
4. Currently receiving chemotherapy, or having had received chemotherapy in the past 6 months
5. Prior treatment with Botulinum Toxin A for any indication within the past 6 months
6. Changes in neuropathic pain modulators within 1 month prior to enrollment or during the course of the trial. Participants who require rescue medications for breakthrough pain can be given so at the discretion of their provider.
7. Hypersensitivity reaction to INA injection
8. Distal muscle weakness and/or atrophy
9. Active infection at injection site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03571334
Study Brief:
Protocol Section:
NCT03571334