Vitamin B3 derivative may soothe Chemotherapy's lingering nerve damage

NCT ID NCT04112641

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether nicotinamide riboside (NIAGEN), a form of vitamin B3, can reduce persistent nerve pain and numbness in cancer survivors who completed chemotherapy with taxane or platinum drugs 1 to 12 months earlier. Participants take either NIAGEN or a placebo daily for 84 days. The study measures changes in sensory and motor nerve symptoms to see if the supplement offers relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nicotinamide riboside (NIAGEN), a form of vitamin B3, taken as oral capsules
What this could lead to
If effective, this could offer a new way to relieve persistent nerve pain and numbness in cancer survivors, improving their quality of life.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not be conclusive. The supplement may not work for everyone, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Donna Hammond

    Iowa City, Iowa, 52245, United States

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