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NR in Chemo-induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03642990
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
ChromaDex, Inc.
Information provided by (Responsible Party):
Donna Hammond, PhD, University of Iowa

Brief Summary:
The purpose of this single-arm phase II trial is to determine whether nicotinamide riboside (NIAGEN®) prevents the progression of peripheral sensory neuropathy in patients receiving paclitaxel for treatment of stage IV breast cancer.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Breast Cancer Metastatic Drug: Nicotinamide Riboside Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects with stage IV breast cancer will receive 300 mg NIAGEN®) daily for one week followed by dose escalation to 1000 mg daily for 11 weeks upon reporting the development of grade 1 sensory neuropathy. Those presenting with a residual sensory neuropathy of ≤ 2 as a result of prior chemotherapy will also be enrolled.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nicotinamide Riboside (NR) in Paclitaxel-induced Peripheral Neuropathy
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NIAGEN®)
Daily oral administration of nicotinamide riboside 300 mg (150 mg a.m. and p.m.) for one week with dose escalation to 1000 mg (500 mg a.m. and p.m.) for remaining 11 weeks.
Drug: Nicotinamide Riboside
Capsule
Other Name: NIAGEN®)




Primary Outcome Measures :
  1. Grade of CIPN as determined by the CTCAE v 4.03 [ Time Frame: approximately 14 weeks ]
    The primary outcome variable is binary (yes/no), and defined as no worsening of the grade of peripheral sensory neuropathy, scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 guidelines.


Secondary Outcome Measures :
  1. Percentage of Patients in which Dose of Paclitaxel in Reduced due to CIPN [ Time Frame: 12 weeks ]
    Quantitate the percentage of patients that experience a dose reduction of paclitaxel therapy due to neuropathy;

  2. Number of Dose Reduction Events [ Time Frame: 12 weeks ]
    Count the number of (i.e. the incidence) of dose reduction events due to neuropathy (each occasion of dose reduction is a separate event);

  3. Total Dose of Paclitaxel Administered [ Time Frame: 12 weeks ]
    Quantitate the total cumulative dose of paclitaxel administered over the 12 weeks.

  4. Score on FACT&GOG-NTX subscale [ Time Frame: 14 weeks ]
    Score on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity questionnaire. This questionnaire asks 11 questions that are specific to chemotherapy-induced peripheral neuropathies.


Other Outcome Measures:
  1. Total Neuropathy Score [ Time Frame: 14 weeks ]
    Exploratory analysis of ability of the clinical version of the Total Neuropathy Score questionnaire to detect changes in CIPN severity over time. Unlike the CTCAE or the FACT&GOG-NTX questionnaires, the TNS is a patient reported outcome measure.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be able to give written informed consent and HIPAA authorization
  • Be 18 to 80 years old
  • Have been diagnosed with stage IV breast cancer of any type, and are anticipated to survive for at least three months
  • Have an ECOG Performance Status of 0-2
  • Able to take medication orally - up to four capsules in the morning (am) and four capsules in the evening (pm).
  • Be undergoing weekly infusions of paclitaxel for treatment of breast cancer and be determined to have at least a grade 1 neuropathy based on the CTCAE version 4.03 guidelines for peripheral sensory neuropathy.
  • Females must be either postmenopausal for at least 1 year or surgically sterile for at least 6 weeks. Females of childbearing potential must have a negative pregnancy test at screening to be eligible for study participation, and agree to take appropriate precautions to avoid pregnancy from screening through follow-up.
  • Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up. The following methods have been determined to be more than 99% effective (<1% failure rate per year when used consistently and correctly) and are permitted under this protocol for use by the patient and his/her partner:

    • Complete abstinence from sexual intercourse when this is in line with the preferred and usual lifestyle of the patient
    • Double barrier methods including condom with spermicide in conjunction with use of an intrauterine device or condom with spermicide in conjunction with use of a diaphragm
  • Surgical sterilization (bilateral oopherectomy with or without hysterectomy, tubal ligation or vasectomy) at least 6 weeks prior to taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and/or estradiol Non-hormonal intrauterine device used as directed by provider placing this is also acceptable.

Exclusion Criteria:

  • Pre-existent peripheral neuropathy that is unrelated to chemotherapy
  • Pre-existent chemotherapy-induced peripheral neuropathy greater than grade 2
  • Known metastases to the brain, spinal cord or peripheral nerves, or leptomeningeal disease
  • Diabetes requiring management by medication
  • Renal or hepatic dysfunction
  • Heavy alcohol use defined at > 8 drinks/week by women or 12 drinks/week by men
  • Chronic pain greater than 3 months duration within the past year.
  • Severe psychiatric illness
  • Pregnancy
  • Current imprisonment
  • Limitations of self-expression, defined as an inability to answer questions posed by physicians, nurses, care-givers, or other members of the investigative team or an inability to describe somatosensations.
  • Known HIV, not on therapy
  • Regular use of nutritional supplements that contain nicotinamide or NIAGEN® within the previous 30 days
  • Use of duloxetine (Cymbalta®) within the previous 30 days
  • Pancreatic insufficiency requiring exocrine enzyme replacement therapy
  • GI conditions where malabsorption of B complex vitamins is known to occur.
  • Known allergy to paclitaxel
  • Breastfeeding

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): NCT03642990


Contacts
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Contact: Donna L Hammond, PhD 319-335-9595 donna-hammond@uiowa.edu
Contact: Marian K Andersen, MS 319-353-4578 marian-andersen@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Donna L Hammond, PhD    319-335-9595    donna-hammond@uiowa.edu   
Contact: Marian K Anderson, MA    319-353-4578    marian-andersen@uiowa.edu   
United States, North Carolina
Wake Forest University Not yet recruiting
Salem, North Carolina, United States, 27109
Contact: Alexandra Thomas, MD    336-716-7217    althomas@wakehealth.edu   
Sponsors and Collaborators
Donna Hammond, PhD
National Cancer Institute (NCI)
ChromaDex, Inc.
Investigators
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Principal Investigator: Donna L Hammond, PhD University of Iowa
Principal Investigator: Alexandra Thomas, MD Wake Forest Unviersity

Publications:

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Responsible Party: Donna Hammond, PhD, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03642990     History of Changes
Other Study ID Numbers: 201612723
R21CA208968 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after de-identification, will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. The IPD will be available to sharing immediately after publication and ending 5 years after article publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be available for sharing immediately after publication and ending 5 years after article publication.
Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Donna Hammond, PhD, University of Iowa:
paclitaxel
nicotinamide riboside
NIAGEN

Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vasodilator Agents