NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    142
  • sponsor
    Donna Hammond, PhD
Updated on 12 December 2021
paclitaxel
cancer
hysterectomy
oxaliplatin
carboplatin
estradiol
ovarian cancer
taxane
peripheral neuropathy

Summary

The purpose of this randomized, double-blind, placebo-controlled, parallel group phase II trial is to determine whether nicotinamide riboside (NIAGEN®, NR) can ameliorate persistent peripheral neuropathy in cancer survivors who have completed chemotherapy with taxane or platinum-complex compounds between 1 and 12 months earlier.

Description

142 patients who have been declared to be in complete remission after treatment of their cancer with either taxane or platinum-based compounds and who have persistent neuropathy will be randomized to receive either placebo or NIAGEN capsules daily for 84 days. On enrollment, subjects will complete several questionnaires characterizing the type and severity of their neuropathy. Their fifth finger will be scanned to determine the density of sensory afferents in the skin, and a skin biopsy will be taken above the ankle for histological analysis of nerve fiber density. Blood samples will be drawn for baseline measures of NAD+ levels, and clinical chemistries and indices of liver and kidney function. Subjects will be asked to return every two weeks to complete the questionnaires, and blood will be drawn to measure biomarkers of NIAGEN consumption. Blood will be drawn at visits on days 28, 56, and 84 for clinical chemistries and measures of liver and kidney function. At visits on day 42 and 84, additional measures of density of nerve fibers in the hand and leg will be made. The last treatment day will be day 84, at which time all measures will be redetermined. A follow-up period of 3 months is planned at which time all measures will be conducted once again to determine if any alleviation of the chemotherapy has persisted after treatment ended. Patients enrolled in this study will receive standard of care treatment by their oncologists, which includes computed tomography, magnetic resonance or ultrasound scans every three months as surveillance for cancer re-occurrence.

Details
Condition Chemotherapy-induced Peripheral Neuropathy
Treatment Placebo capsules, Nicotinamide Riboside
Clinical Study IdentifierNCT04112641
SponsorDonna Hammond, PhD
Last Modified on12 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Be able to give written informed consent and HIPAA authorization
Be ≥ 18 and ≤ 85 years of age
Have received chemotherapy with taxane (e.g. paclitaxel, nab-paclitaxel, or docetaxol) or platinum-complex (e.g. oxaliplatin, carboplatin, or cisplatin) (alone or in combination) and completed therapy no sooner than 1 month and no later than 1 year earlier
Have been treated with above compounds for head and neck cancer, small cell lung cancer, sarcoma, ovarian cancer, endometrial cancer, colorectal cancer, or breast cancer and been declared to have no visible evidence of disease
Have an Eastern Cooperative Oncology Group (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 determined to have a raw score of ≥ 12 on the sensory subscale or ≥ 11 on the motor subscale of the QLQ-CIPN20 questionnaire
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) [69] 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
Condom with spermicide in conjunction with use of an intrauterine device
Condom with spermicide in conjunction with use of a diaphragm
Surgical sterilization (bilateral oophorectomy 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
Recurrent ovarian or endometrial cancer
Diabetes managed by medication
Neutrophils < 1,000 cells/m3
Hemoglobin < 8.0 g/dcl
Platelets < 100,000 cells/m3
Creatinine clearance < 30 ml/min
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values > 2.5 X upper limits of normal
Total bilirubin > 2.0 X upper limits of normal
Heavy alcohol use defined at > 8 drinks/week by women or 12 drinks/week by men
Psychiatric illness that, in the opinion of the investigator, would interfere with the ability of the individual to participate in or complete the study
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
Regular use of nutritional supplements that contain nicotinamide riboside (e.g. NIAGEN, TRuNIAGEN, Basis, NAD+ Cell Regenerator) within the previous 30 days
Use of duloxetine (Cymbalta®) or any other drug for treatment of peripheral neuropathy such as gabapentin, pregabalin, lamotrigine, or amitryptyline
Pancreatic insufficiency requiring exocrine enzyme replacement therapy
GI conditions where malabsorption of B complex vitamins is known to occur
Breastfeeding
Allergy to epinephrine or local anesthetics
Bleeding disorder
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