Evaluation of Hydroxychloroquine to Prevent CIPN
Breast Cancer, Gynecologic Cancer, Early-stage Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Chemotherapy Induced Peripheral Neuropathy, Hydroxycloroquine, Diffusion Tensor Imaging, Breast Cancer, Gynecologic Cancer, Paclitaxel, Neoadjuvant chemotherapy
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.
Sites / Locations
- University of Arizona Cancer Center
Arms of the Study
Arm 1
Experimental
Addition of Hydroxychloroquine to paclitaxel
Hydroxychloroquine will be added to chemotherapy in patients with early stage (1-3) breast cancer and gynecological cancers.