Chemotherapy-induced Peripheral NeuropathyPhase 2NCT04112641
NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy
A Phase 2 study testing Nicotinamide riboside in people with Chemotherapy-induced Peripheral Neuropathy, run by Donna Hammond, PhD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Nicotinamide riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alleviation by NIAGEN of Persistent Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors
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.
Read the detailed description
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.
- Being tested
- Nicotinamide riboside, Placebo capsules
- Keywords
- peripheral neuropathy, chemotherapy, taxane, platinum compound
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide ribosideDrug
Also called NIAGEN
Daily oral ingestion of 1 g/day NIAGEN in capsule form for 84 days; two capsules in the a.m. and two capsules in the p.m.
Placebo capsulesDrug
Also called Placebo
Daily oral ingestion of placebo in capsule form for 84 days; two capsules in the a.m. and two capsules in the p.m.
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsules | Placebo comparator | Subjects will take 2 capsules in the a.m. and 2 capsules in the p.m. daily for 84 days. Receives: Drug: Placebo capsules |
| Nicotinamide Riboside (NIAGEN) | Experimental | Subjects will take 2 250-mg capsules in the a.m. and 2 250- mg capsules in the p.m. daily (total daily dose is 1 g) for 84 days. Receives: Drug: Nicotinamide riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Sensory Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
Change in score from baseline to end of treatment at 84 days. The Quality of Life Questionnaire for Chemotherapy-induced Peripheral Neuropathy (20 questions) or QLQ-CIPN20 yields scores of 1-4 (Likert scale) for 9 sensory, 8 motor, and 3 autonomic sequelae of chemotherapy. The minimum score for the sensory subscale is 9 and the maximum possible score is 36. The higher the score, the worse the signs and symptoms. The raw score can, at the investigator's discretion, be linearly transformed to a 0-100 scale, where higher numbers represent worse symptoms.
Recent publications call the validity of the autonomic scale into question, and it is not being used in this study.
Measured: 84 days
Score on Motor Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
Change in score from baseline to end of treatment at 84 days. The Quality of Life Questionnaire for Chemotherapy-induced Peripheral Neuropathy (20 questions) or QLQ-CIPN20 yields scores of 1-4 (Likert scale) for 9 sensory, 8 motor, and 3 autonomic sequelae of chemotherapy. The minimum score for the motor subscale is 8 and the maximum possible score is 32. The higher the score, the worse the signs and symptoms. The raw score can, at the investigator's discretion, be linearly transformed to a 0-100 scale, where higher numbers represent worse symptoms.
Recent publications call the validity of the autonomic scale into question, and it is not being used in this study.
Measured: 84 days
Secondary outcomes (2)
Total Neuropathy Score - clinical questionnaire
Change in score from baseline to end of treatment at 84 days. The clinical version of the Total Neuropathy Score yields scores of 0-4 on 6 items (sensory symptoms, motor symptoms, pin sensibility, vibration sensibility, strength and deep tendon reflex). The minimum possible score is 0 and the maximum possible score is 30. Scores for each of the six items are summed to yield a single total score. The higher the score, the worse the outcome.
Measured: 84 days
Intraepidermal Nerve Fiber Density
Change in score from baseline to end of treatment at 84 days
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start19 Feb 2020
- Primary completion28 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two independent treatment arms to which patients will be randomized by variable size blocks
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donna Hammond, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donna Hammond, PhD, University of Iowa
- Investigators
- Mohammed Milhem, M.D., Principal investigator, University of IowaDonna Hammond, Ph.D., Principal investigator, University of IowaMichael Shy, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112641
- Sponsor's protocol ID
- 201909843
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2019
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviation by NIAGEN of Persistent Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors
- ClinicalTrials.gov ID
- NCT04112641
- Acronym / sponsor ID
- 201909843
- Keywords
- peripheral neuropathy, chemotherapy, taxane, platinum compound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Donna Hammond, PhDUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two independent treatment arms to which patients will be randomized by variable size blocks
| Arm | Type | Receives |
|---|---|---|
| Placebo capsules | Placebo comparator | Drug: Placebo capsulesSubjects will take 2 capsules in the a.m. and 2 capsules in the p.m. daily for 84 days. |
| Nicotinamide Riboside (NIAGEN) | Experimental | Drug: Nicotinamide ribosideSubjects will take 2 250-mg capsules in the a.m. and 2 250- mg capsules in the p.m. daily (total daily dose is 1 g) for 84 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide ribosideAlso: NIAGENDaily oral ingestion of 1 g/day NIAGEN in capsule form for 84 days; two capsules in the a.m. and two capsules in the p.m. | Drug | Nicotinamide Riboside (NIAGEN) |
| Placebo capsulesAlso: PlaceboDaily oral ingestion of placebo in capsule form for 84 days; two capsules in the a.m. and two capsules in the p.m. | Drug | Placebo capsules |
Primary outcome
Score on Sensory Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
Time frame: 84 days
Change in score from baseline to end of treatment at 84 days. The Quality of Life Questionnaire for Chemotherapy-induced Peripheral Neuropathy (20 questions) or QLQ-CIPN20 yields scores of 1-4 (Likert scale) for 9 sensory, 8 motor, and 3 autonomic sequelae of chemotherapy. The minimum score for the sensory subscale is 9 and the maximum possible score is 36. The higher the score, the worse the signs and symptoms. The raw score can, at the investigator's discretion, be linearly transformed to a 0-100 scale, where higher numbers represent worse symptoms. Recent publications call the validity of the autonomic scale into question, and it is not being used in this study.
Score on Motor Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
Time frame: 84 days
Change in score from baseline to end of treatment at 84 days. The Quality of Life Questionnaire for Chemotherapy-induced Peripheral Neuropathy (20 questions) or QLQ-CIPN20 yields scores of 1-4 (Likert scale) for 9 sensory, 8 motor, and 3 autonomic sequelae of chemotherapy. The minimum score for the motor subscale is 8 and the maximum possible score is 32. The higher the score, the worse the signs and symptoms. The raw score can, at the investigator's discretion, be linearly transformed to a 0-100 scale, where higher numbers represent worse symptoms. Recent publications call the validity of the autonomic scale into question, and it is not being used in this study.
2 secondary outcomes
Total Neuropathy Score - clinical questionnaire
Time frame: 84 days
Intraepidermal Nerve Fiber Density
Time frame: 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Milhem, M.D. principal investigator
University of Iowa
Donna Hammond, Ph.D. principal investigator
University of Iowa
Michael Shy, M.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide riboside in people with Chemotherapy-induced Peripheral Neuropathy, run by Donna Hammond, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Sensory Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20) (time frame: 84 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.