Clinical trial NCT05689359: Evaluation of Hydroxychloroquine to Prevent CIPN
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Gynecologic Cancer
Early-stage Breast Cancer
Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Keywords: Chemotherapy Induced Peripheral Neuropathy
Hydroxycloroquine
Diffusion Tensor Imaging
Breast Cancer
Gynecologic Cancer
Paclitaxel
Neoadjuvant chemotherapy
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Symptomatic CIPN
timeFrame: Throughout study completion, an average of 6 months
Secondary outcomes:
measure: Predicting Symptomatic CIPN: FA and ADC values derived from DTI
timeFrame: Baseline
measure: Predicting Symptomatic CIPN: change in FA and ADC
timeFrame: Baseline and 12 weeks
measure: Predicting Symptomatic CIPN: baseline NF-L levels
timeFrame: Baseline
measure: Predicting Symptomatic CIPN: Changes in NF-L levels
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Jennifer Segar, MD
role: PRINCIPAL_INVESTIGATOR
References: