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NIAGEN for the Alleviation of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors

Trial Status: Active

The phase II trial studies how well NIAGEN works in reducing peripheral neuropathy caused by chemotherapy in cancer survivors who have completed their cancer treatment. NIAGEN is a nutritional supplement and type of vitamin B3. NIAGEN may help alleviate peripheral neuropathy that persists in patients who have completed cancer treatment.

Inclusion Criteria

  • Be able to give written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Have received chemotherapy with taxane (e.g. paclitaxel, nab-paclitaxel, or docetaxel) 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 15 months earlier
  • Have been treated with above compounds for head and neck cancer, small cell lung cancer, ovarian cancer, fallopian tube cancer, endometrial cancer, peritoneal cancer, colorectal cancer, sarcoma, 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 Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (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) 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 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
  • Recurrent ovarian, fallopian, peritoneal, or endometrial cancer
  • Diabetes managed by medication
  • Neutrophils < 1,000 cells/m^3
  • Hemoglobin < 8.0 g/dcl
  • Platelets < 100,000 cells/m^3
  • Creatinine clearance < 30 ml/min
  • Aspartate transaminase (AST) or alanine transferase (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 human immunodeficiency virus (HIV)
  • Regular use of nutritional supplements that contain nicotinamide, nicotinamide mononucleotide, or nicotinamide riboside within the previous 30 days
  • Use of duloxetine (Cymbalta)
  • Pancreatic insufficiency requiring exocrine enzyme replacement therapy
  • Gastrointestinal (GI) conditions where malabsorption of B complex vitamins is known to occur
  • Breastfeeding
  • Allergy to epinephrine or local anesthetics
  • Bleeding disorder

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Donna Hammond
Phone: 319-335-9595

PRIMARY OBJECTIVE:

I. To determine whether daily administration of 1 g/day nicotinamide riboside (NIAGEN) will ameliorate chemotherapy-induced peripheral neuropathy (CIPN) that persists in cancer survivors between 1 and 15 months after completion of taxane- or platinum compound-based chemotherapy, alone or in combination.

SECONDARY OBJECTIVES:

I. To determine whether treatment with NIAGEN can

Ia. Diminish the score on the Total Neuropathy Score – clinical version (TNSc) questionnaire.

Ib. Normalize the anticipated chemotherapy-induced decrease in the density of intra-epidermal nerve fibers of the distal leg.

Ic. Normalize the anticipated chemotherapy-induced increase in the sensitivity of the cornea to tactile stimuli.

EXPLORATORY OBJECTIVES:

I. To determine whether the effect of NIAGEN is specific to a particular class of chemotherapeutic agent.

II. To determine the time-course for resolution of CIPN by NIAGEN.

III. To determine whether NIAGEN’s efficacy depends on the timing of the intervention relative to the conclusion of chemotherapy.

IV. To determine the time-course for changes in intra-epidermal nerve fiber density in placebo and NIAGEN-treated subjects.

V. To determine changes in the density of innervation of the glabrous surface of digit V of the non-dominant hand as determined by in vivo reflectance confocal microscopy.

VI. To determine whether NIAGEN improves scores on the Ocular Surface Disease Index (OSDI).

VII. To determine whether reversal of CIPN persists 3 months after NIAGEN treatment ends.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive nicotinamide riboside orally (PO) twice daily (BID). Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive placebo PO BID. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed up at 12-16 weeks.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
University of Iowa / Holden Comprehensive Cancer Center

Principal Investigator
Donna Hammond

  • Primary ID 201909843
  • Secondary IDs NCI-2020-01457
  • Clinicaltrials.gov ID NCT04112641