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NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy

StatusActive, Not Recruiting
PhasePhase 2
Started2020-02-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 28, 2026 → Jun 28, 2027
See other at-risk trials from Donna Hammond, PhD

Amendment history

2026-08-18
Study Status, Oversight v12
Primary completion pushed: 2026-06-28 → 2027-06-28
Completion pushed: 2026-07-01 → 2027-12-01
2025-07-25
Study Status, Oversight v11
Primary completion date2025-02-28→2026-06-28
Completion date2025-03-01→2026-07-01
2024-07-08
Study Status v10
Primary completion date2024-02-28→2025-02-28
Completion date2024-03-01→2025-03-01
2024-01-18
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2023-03-17
Study Status v8
Primary completion date2023-02-28→2024-02-28
Completion date2023-03-01→2024-03-01
Show 7 earlier versions
2022-01-24
Study Status, Study Description, Study Design, Contacts/Locations v7
Enrollment target142→48
Study description-4 characters
142 patientsPatients who have been declared to be in complete remission after tr [...]
Study sitescontacts updated at 1 of 1 site
2021-12-03
Study Status, Eligibility v6
Eligibility criteria+39 characters
[...] ar use of nutritional supplements that contain nicotinamide orriboside nicotinamide(e.g. NIAGEN, ribosideTRuNIAGEN, Basis, NAD+ Cell Regenerator) within the previous 30 days Use of duloxetine (Cymbalta®) o [...]
2021-09-27
Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Contacts/Locations v5
Lead sponsorUniversity of Iowa→Donna Hammond, PhD
Secondary endpoints3 to 2 entries
Corneal Sensitivity
Study description-92 characters
[...] s characterizing the type and severity of their neuropathy. The sensitivity of their cornea to light touch will be determined, theirTheir fifth finger will be scanned to determine the density of se [...] function. At visits on day 42 and 84, additional measures of corneal sensitivity, and density of nerve fibers in the hand and leg will be made. T [...]
Study sitescontacts updated at 1 of 1 site
Collaborators-16 characters
The V Foundation
2020-09-21
Study Status, Eligibility v4
Eligibility criteriarevised
[...] in the evening (pm). Be determined to have a raw score of ≥ 1812 on the sensory subscale or ≥ 1611 on the motor subscale of the QLQ-CIPN20 questionnaire. Fema [...]
2020-05-20
Study Status, Eligibility, Contacts/Locations v3
Start dateestimated 2020-02-28→confirmed 2020-02-19
Eligibility criteria+26 characters
[...] compounds for head and neck cancer, small cell lung cancer, sarcoma, ovarian cancer, endometrial cancer, colorectal cancer, or breast cancer and been declared into completehave remissionno visible evidence of disease. Have an Eastern Cooperative Oncology Group (ECOG) Performa [...]
2020-02-14
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-01-01→2023-02-28
Completion date2022-03-01→2023-03-01
Start date2019-12-01→2020-02-28
Study sites0→1
Eligibility criteria+120 characters
[...] de 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 replacem [...]
2019-10-01
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 3 entries
Primary endpoints2 entries, revised
Score on Motor Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20 questionnaire)
2019-10-01
Original filing
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.
Trial Details
NCT Number NCT04112641
Lead Sponsor Donna Hammond, PhD
Conditions Chemotherapy-induced Peripheral Neuropathy
Enrollment 48 participants
Start Date 2020-02-19
Primary Completion 2027-06-28 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-20