NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy
United States48 participantsStarted 2020-02-19
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 correc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Score on Sensory Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
Timeframe: 84 days
2
Score on Motor Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)