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Vitamin
NR in Chemo-induced Peripheral Neuropathy
Phase 2
Waitlist Available
Led By Alexandra Thomas, MD
Research Sponsored by Donna Hammond, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether nicotinamide riboside (a form of vitamin B3) can prevent nerve pain in cancer patients receiving certain chemotherapy drugs. It works by increasing NAD+ levels to protect nerve cells. The study focuses on patients with specific types of cancer who are experiencing nerve pain from their treatment.
Eligible Conditions
- Head and Neck Cancers
- Breast cancer
- Endometrial Cancer
- Peripheral Neuropathy
- Ovarian Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With No Worsening in the Grade of Peripheral Sensory Neuropathy as Scored by CTCAE
Secondary study objectives
Difference in Score Between Baseline and End of Treatment for the FACT&GOG-NTX Subscale .
Number of Dose Reduction Events
Percentage of Patients in Which Dose of Paclitaxel or Nab-Paclitaxel is Reduced Due to CIPN
+1 moreOther study objectives
Difference in Total Neuropathy Score Between Screening and End of Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NIAGEN®)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide riboside
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Donna Hammond, PhDLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,165 Total Patients Enrolled
290 Trials studying Ovarian Cancer
76,723 Patients Enrolled for Ovarian Cancer
ChromaDex, Inc.Industry Sponsor
7 Previous Clinical Trials
393 Total Patients Enrolled
Alexandra Thomas, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center
2 Previous Clinical Trials
115 Total Patients Enrolled
Donna L Hammond, PhDPrincipal InvestigatorUniversity of Iowa