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Evaluation of Hydroxychloroquine to Prevent CIPN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05689359
Recruitment Status : Not yet recruiting
First Posted : January 19, 2023
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Gynecologic Cancer Early-stage Breast Cancer Peripheral Neuropathy Chemotherapy-induced Peripheral Neuropathy Drug: Hydroxychloroquine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Addition of Hydroxychloroquine to paclitaxel
Hydroxychloroquine will be added to chemotherapy in patients with early stage (1-3) breast cancer and gynecological cancers.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Symptomatic CIPN [ Time Frame: Throughout study completion, an average of 6 months ]
    The primary endpoint is symptomatic CIPN defined as increase in in FACT-GOG/Ntx-12 questionnaire score of greater than or equal to 3 points post-chemotherapy with hydroxychloroquine in combination with paclitaxel chemotherapy in patients with early-stage breast cancer or gynecologic malignancies.


Secondary Outcome Measures :
  1. Predicting Symptomatic CIPN: FA and ADC values derived from DTI [ Time Frame: Baseline ]
    Baseline fractional anisotrophy (FA) and apparent diffusion coefficient (ADC) values derived from DTI will be used to predict symptomatic CIPN prior to starting and end of chemotherapy.

  2. Predicting Symptomatic CIPN: change in FA and ADC [ Time Frame: Baseline and 12 weeks ]
    Change in mean FA and ADC prior to starting and end of chemotherapy will be calculated. The mean of the change in FA and ADC values with 95% confidence intervals will be estimated (post- minus pre- chemotherapy). The baseline values and the change of FA and ADC will be used to predict the development of symptomatic CIPN using logistic regression.

  3. Predicting Symptomatic CIPN: baseline NF-L levels [ Time Frame: Baseline ]
    Baseline level of neurofilament light chain (NF-L) will be used to predict symptomatic CIPN. The baseline values will be used to predict development of symptomatic CIPN using logistic regression.

  4. Predicting Symptomatic CIPN: Changes in NF-L levels [ Time Frame: Baseline and 12 weeks ]
    Changes in NF-L levels with chemotherapy used to predict development of symptomatic CIPN. NF-L measures will be summarized across time and analyzed using linear mixed effects model.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05689359


Contacts
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Contact: Alexia Demitsas 520-694-9089 ademitsas@arizona.edu

Locations
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United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Jennifer Segar, MD University of Arizona
More Information
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT05689359    
Other Study ID Numbers: STUDY00001721
First Posted: January 19, 2023    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Arizona:
Chemotherapy Induced Peripheral Neuropathy
Hydroxycloroquine
Diffusion Tensor Imaging
Breast Cancer
 Gynecologic Cancer
Paclitaxel
Neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
 Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents