Evaluation of Hydroxychloroquine to Prevent CIPN

NCT ID: NCT05689359

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Addition of Hydroxychloroquine to paclitaxel

Hydroxychloroquine will be added to chemotherapy in patients with early stage (1-3) breast cancer and gynecological cancers.

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent
• Age ≥ 21 years old
• No prior neurotoxic chemotherapies
• No other neurotoxic chemotherapies planned during paclitaxel treatment (i.e, platinum)
• Need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician
• Be able to undergo MR Imaging
• Be willing to comply with scheduled visits, treatment plan, and MR imaging
• Adequate organ function as defined as:

Hematologic:

Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL

Hepatic:

Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN

Renal:

Estimated creatinine clearance (CrCl)≥ 50 mL/min by Cockcroft-Gault formula

Exclusion Criteria

• Stage IV cancer
• CTCAE neurological function > grade 1 at baseline
• Mental limitation that precludes understanding of or completion of questionnaires
• History of diabetes or other neurological disorders
• Preexisting peripheral neuropathy
• Prior exposure to neurotoxic chemotherapy
• Currently taking medication to treat or prevent neuropathy
• Have non-MRI compatible metallic objects on/in body
• Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
• Pregnant or lactating patients. Women of childbearing potential and sexually active men must use an effective contraception method during rreatment and for three months after completing treatment. Patients of childbearing potential must have a negative serum or urine B-hCG pregnancy test at screening.
• History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity) or macular degeneration.
• QTc prolongation defined as a QTcF > 500 ms
• Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Segar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Other Identifiers

STUDY00001721

Identifier Type: -

Identifier Source: org_study_id