Evaluation of Hydroxychloroquine to Prevent CIPN

University of Arizona

Status and phase

Withdrawn

Phase 2

Conditions

Breast Cancer

Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy

Early-stage Breast Cancer

Gynecologic Cancer

Treatments

Drug: Hydroxychloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT05689359

STUDY00001721

Details and patient eligibility

About

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.

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.