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Not Yet Recruiting NCT05689359

Evaluation of Hydroxychloroquine to Prevent CIPN

Conditions: Breast Cancer, Gynecologic Cancer, Early-stage Breast Cancer, Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy

Sex: Female
Ages: 21 Years – N/A
Phase: PHASE2
Enrollment: 24
Sponsor: University of Arizona

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intentAge ≥ 21 years oldNo prior neurotoxic chemotherapiesNo 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 physicianBe able to undergo MR ImagingBe willing to comply with scheduled visits, treatment plan, and MR imagingAdequate organ function as defined as:Hematologic:Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dLHepatic:Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULNRenal:Estimated creatinine clearance (CrCl)≥ 50 mL/min by Cockcroft-Gault formulaExclusion Criteria:Stage IV cancerCTCAE neurological function > grade 1 at baselineMental limitation that precludes understanding of or completion of questionnairesHistory of diabetes or other neurological disordersPreexisting peripheral neuropathyPrior exposure to neurotoxic chemotherapyCurrently taking medication to treat or prevent neuropathyHave non-MRI compatible metallic objects on/in bodyHave metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examinationPregnant 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 msKnown glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05689359). StuddyBuddy aggregates publicly available trial information.