Clinical trial · Interventional
NR in Chemo-induced Peripheral Neuropathy
Nicotinamide Riboside (NR) in Paclitaxel-induced Peripheral Neuropathy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment challenges
Summary
Brief summary (as posted)
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 infusions of paclitaxel or nab-paclitaxel for the treatment of metastatic breast cancer or recurrent platinum-resistant ovarian, endometrial, peritoneal, fallopian tube cancer or metastatic head and neck cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Metastatic | — | UNRESOLVED | — |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Endometrial Cancer Stage IV | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer Stage IV | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
| Platinum-resistant Recurrent Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nicotinamide Riboside | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NIAGEN®)
- description
- 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.
- interventionNames
- Drug: Nicotinamide Riboside
Primary outcomes (1)
- measure
- Number of Participants With No Worsening in the Grade of Peripheral Sensory Neuropathy as Scored by CTCAE
- timeFrame
- approximately 4 weeks
- description
- The primary outcome variable is defined as no worsening of the grade of peripheral sensory neuropathy as scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 guidelines. Per the CTCAE a score of 1 would be assigned in the instance of parethesias or a loss of deep tendon reflexes. A score of 2 would be assigned in the instance of moderate symptoms that limit instrumental activities of daily living. A score of 3 would be assigned in the instance of severe symptoms that limit self-care activities of daily living. Because the outcome measure is defined as no worsening of the grade, it was recorded as either "yes"( i.e. it worsened) or "no" (i.e. it did not worsen).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Be able to give written informed consent and HIPAA authorization * Be 18 to 85 years old * Have been diagnosed with stage IV breast cancer of any type, platinum-resistant recurrent ovarian, peritoneal, endometrial, or fallopian tube cancer, or platinum-resistant recurrent or metastatic head and neck cancer 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 infusions of paclitaxel or nab-paclitaxel for treatment of breast cancer, platinum-resistant recurrent ovarian, peritoneal, endometrial, or fallopian tube cancer, or platinum-resistant recurrent or metastatic head and neck cancer and be determined to have at least a grade 1 neuropathy based on the CTCAE version 4.03 guidelines for peripheral sensory neuropathy. Breast cancer patients may also be treated concomitantly with monoclonal antibodies to HER2 such as trastuzumab (Herceptin) and pertuzumab (Perjeta). Patients with platinum-resistant ovarian, peritoneal, endometrial, or fallopian tube cancer or platinum-resistant recurrent or metastatic head and neck cancer may also be treated concomitantly with a vascular endothelial growth receptor 2 inhibitor such as bevacizumab (Avastin) or a checkpoint inhibitor. * 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 * Concurrent administration of a poly (ADP-Ribose) polymerase inhibitor (e.g. olaparib, rucaparib) * Concurrent administration of a platinum-based chemotherapy * Diabetes requiring management by medication * Diabetes managed by medication * Neutrophils \< 1,000 cells/m3 * Hemoglobin \< 8.0 g/dcl * Platelets \< 100,000 cells/m3 * Creatinine clearance \< 30 ml/min * AST or 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 * 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 Cremophor vehicle used to deliver paclitaxel in its Taxol formulation * Breastfeeding
References
Publications (23)
- BACKGROUNDSeretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23. PMID 25261162
- BACKGROUNDArgyriou AA, Bruna J, Marmiroli P, Cavaletti G. Chemotherapy-induced peripheral neurotoxicity (CIPN): an update. Crit Rev Oncol Hematol. 2012 Apr;82(1):51-77. doi: 10.1016/j.critrevonc.2011.04.012. Epub 2011 Sep 10. PMID 21908200
- BACKGROUNDArgyriou AA, Kyritsis AP, Makatsoris T, Kalofonos HP. Chemotherapy-induced peripheral neuropathy in adults: a comprehensive update of the literature. Cancer Manag Res. 2014 Mar 19;6:135-47. doi: 10.2147/CMAR.S44261. eCollection 2014. PMID 24672257
- BACKGROUNDMiltenburg NC, Boogerd W. Chemotherapy-induced neuropathy: A comprehensive survey. Cancer Treat Rev. 2014 Aug;40(7):872-82. doi: 10.1016/j.ctrv.2014.04.004. Epub 2014 Apr 18. PMID 24830939
- BACKGROUNDPark SB, Goldstein D, Krishnan AV, Lin CS, Friedlander ML, Cassidy J, Koltzenburg M, Kiernan MC. Chemotherapy-induced peripheral neurotoxicity: a critical analysis. CA Cancer J Clin. 2013 Nov-Dec;63(6):419-37. doi: 10.3322/caac.21204. PMID 24590861
- BACKGROUNDBieganowski P, Brenner C. Discoveries of nicotinamide riboside as a nutrient and conserved NRK genes establish a Preiss-Handler independent route to NAD+ in fungi and humans. Cell. 2004 May 14;117(4):495-502. doi: 10.1016/s0092-8674(04)00416-7. PMID 15137942
- BACKGROUNDTrammell SA, Yu L, Redpath P, Migaud ME, Brenner C. Nicotinamide Riboside Is a Major NAD+ Precursor Vitamin in Cow Milk. J Nutr. 2016 May;146(5):957-63. doi: 10.3945/jn.116.230078. Epub 2016 Apr 6.