Trials / Withdrawn
WithdrawnNCT05689359
Evaluation of Hydroxychloroquine to Prevent CIPN
Phase 2, Single Center, Single Arm Study to Evaluate the Decrease in CIPN With the Addition of Hydroxychloroquine to Chemotherapy in Patients With Early Stage (1-3) Breast Cancer and Gynecological Cancers Treated With Curative Intent
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The study is being done to research if hydroxychloroquine can prevent chemotherapy induced peripheral neuropathy. Certain chemotherapy drugs, like paclitaxel, are known to cause neuropathy which can impact quality of life. Currently, there are no options for preventing peripheral neuropathy. In addition, there are no useful methods to assess peripheral nerve damage. This study will also explore using a study MRI of patients' feet prior to starting chemotherapy and after they have completed chemotherapy to see if there is any difference in their nerve structure.
Conditions
- Breast Cancer
- Gynecologic Cancer
- Early-stage Breast Cancer
- Peripheral Neuropathy
- Chemotherapy-induced Peripheral Neuropathy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydroxychloroquine | Hydroxychloroquine will be administered at 600 mg po BID for 3 days prior to starting chemotherapy, continued during the course of chemotherapy, and for 7 days after chemotherapy. |
Timeline
- Start date
- 2024-06-01
- Primary completion
- 2025-02-01
- Completion
- 2025-12-01
- First posted
- 2023-01-19
- Last updated
- 2024-03-08
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05689359. Inclusion in this directory is not an endorsement.