CLINICAL TRIAL

Nicotinamide riboside for Peripheral Nervous System Diseases

Recruiting · 18+ · All Sexes · Iowa City, IA

This study is evaluating whether nicotinamide riboside may help improve neuropathy in cancer survivors.

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About the trial for Peripheral Nervous System Diseases

Eligible Conditions
Peripheral Nervous System Diseases · Chemotherapy-induced Peripheral Neuropathy

Treatment Groups

This trial involves 2 different treatments. Nicotinamide Riboside is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nicotinamide riboside
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo capsules
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide riboside
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I have completed chemotherapy with a taxane (paclitaxel, nab-paclitaxel, or docetaxol) or platinum-complex (oxaliplatin, carboplatin, or cisplatin) within the past year. show original
The subjects have been treated with the compounds mentioned above for head and neck cancer, small cell lung cancer, sarcoma, ovarian cancer, endometrial cancer, colorectal cancer, or breast cancer, and they have been declared to have no visible evidence of disease. show original
is the best means of preventing the transmission of the AIDS virus show original
The person needs to be able to write out that they agree to the procedure, and also agree to any HIPAA regulations that may be in place. show original
The person must be 18 years old or older, and no older than 85. show original
Aim to have a raw score of 12 or more on the sensory subscale or 11 or more on the motor subscale of the QLQ-CIPN20 questionnaire. show original
Females must either be postmenopausal for at least 1 year or surgically sterile for at least 6 weeks in order to be eligible for study participation show original
Have a performance status of 0-2 as assessed by the Eastern Cooperative Oncology Group (ECOG). show original
Can take medication orally - up to four capsules in the morning and four capsules in the evening. show original
Double barrier methods
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 84 days
Screening: ~3 weeks
Treatment: Varies
Reporting: 84 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 84 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nicotinamide riboside will improve 2 primary outcomes and 3 secondary outcomes in patients with Peripheral Nervous System Diseases. Measurement will happen over the course of 84 days.

Total Neuropathy Score - clinical questionnaire
84 DAYS
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.
84 DAYS
Score on Motor Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
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.
84 DAYS
Intraepidermal Nerve Fiber Density
84 DAYS
Change in score from baseline to end of treatment at 84 days
84 DAYS
Corneal Sensitivity
84 DAYS
Change in score from baseline to end of treatment at 84 days
84 DAYS
Score on Sensory Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
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.
84 DAYS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get peripheral nervous system diseases a year in the United States?

The American Cancer Society estimates that 2,100 cases of peripheral nerve neuropathy will be noticed in people over the age of 20 a year in the United States.

Anonymous Patient Answer

What are the signs of peripheral nervous system diseases?

Symptoms such as painless paresthesia, burning sensation and itching and muscle weakness may suggest disorders of peripheral nervous system. The differential diagnosis should be considered while a patient presents with neuropathic symptoms in the context of a systemic disease with involvement of nervous system. The signs of peripheral nervous system disease are often subtle and may be missed easily. It is prudent for clinicians to keep a list of possible causes for patients presenting with neuropathic symptoms. They may include trauma, surgery, systemic diseases, malignancy, chronic infection, vasculitis, Behçet's disease, drug toxicity, multiple sclerosis, amyloidosis, neurogastroenteropathy and neuromuscular disorders.

Anonymous Patient Answer

What is peripheral nervous system diseases?

The word 'phrenic' means 'of the nerves'. The word 'peripheral' comes from the Greek περι ('peri' 'around') and ᾤφηρες ('phèrès' 'nerves'), so that 'the nerves of the peripheral nervous system'.\n

Anonymous Patient Answer

What causes peripheral nervous system diseases?

Peripheral nervous system diseases can arise due to any disease. Though peripheral neuropathy is not contagious, it is more common in some people with a disease such as diabetes, or alcoholism. If the disease is untreated it can become symptomatic. Prevention includes health education and smoking control.\n

Anonymous Patient Answer

Can peripheral nervous system diseases be cured?

All chronic central or peripheral PNMDs can be cured by conservative treatment. Patients with chronic PNMD who suffer disabling pain resulting in limited activities of daily living may not improve if they were first treated with medication or surgical procedures that do not restore normal sensation.

Anonymous Patient Answer

What are common treatments for peripheral nervous system diseases?

A significant portion of people with PN have [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain). In addition, neuropathic pain, headache, and chronic migraines are common diagnoses of PN. Although treatment for PN often includes a variety of drugs and medical procedures, such as tricyclic antidepressants and anticonvulsants, these often lead to only a limited benefit in terms of pain control.

Anonymous Patient Answer

How serious can peripheral nervous system diseases be?

Results from a recent clinical trial showed that when doctors treat PNS diseases, there is a concern for the probability of severe complications that make it necessary to perform a decompression operation prior to the treatment of most patients. If the patient has a decompression disorder, but still has no neurological deterioration, it is very unlikely that the condition will be life-threatening. If neurological deterioration has occurred in the past, these patients should be monitored with a high index of suspicion and prompt decompression of the nervous system.

Anonymous Patient Answer

What is the primary cause of peripheral nervous system diseases?

The diagnosis of central and peripheral nervous system diseases were determined mostly by referral bases rather than by formal diagnostic criteria set by researchers. Patients with both central and peripheral nervous system disease were more likely to have multiple diagnoses.

Anonymous Patient Answer

Is nicotinamide riboside typically used in combination with any other treatments?

Nucleoside analogues are often prescribed as adjuvant treatment in patients with NBSCC. There is low patient compliance rates and low overall clinical outcomes in the real-world patient population. Nucleoside analogues are used with other anticancer therapy, such as bleomycin, taxanes (paclitaxel), or capecitabine to improve outcomes. However, there are few randomized trial data to guide treatment strategy. Nicotinamide riboside has not been studied in any randomized trials. This article is open-access; it is available to all. ClinicalTrials.gov registered protocols: NCT00241361 and NCT00241362.

Anonymous Patient Answer

What does nicotinamide riboside usually treat?

In a recent study, findings suggest that it might be reasonable to consider NAM as an alternative to the conventional treatment of patients with high-risk PN.

Anonymous Patient Answer

What is the latest research for peripheral nervous system diseases?

Most recent scientific information deals only with general management, but is mainly anecdotal. Most research in this area is based at small-scale clinical studies, and the results are very variable depending on the disease and medical treatment studied. In particular, the evidence regarding the long-term outcome of children with Spina bifida is lacking, and further studies comparing surgical approaches to nonsurgical approaches of Spina bifida repair are needed. This knowledge would facilitate better patient counselling and support during treatments and following the disease development.

Anonymous Patient Answer

What is the average age someone gets peripheral nervous system diseases?

Nervous system diseases account for an increasing number of patients seen in all medical specialties. More than half of patients with Nervous System Disorders require hospitalization and a third of patients are on non-clinical therapies. In the US, these diseases affect both males and females. Age is a risk factor for all types of peripheral nervous system disease; however, it has been reported that Nervous System Disorders are the greatest risk factor for children and females of a given age. Other factors may include lifestyle, race, family history of disease, and genetics. The most common forms of peripheral nervous system disorders are diabetic neuropathy or peripheral neuropathy and Guillain-Aarrhum syndrome.

Anonymous Patient Answer
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