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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03642990
Other study ID # 201612723
Secondary ID R21CA208968
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 8, 2019
Est. completion date February 24, 2022

Study information

Verified date March 2023
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this single-arm phase II trial is to determine whether nicotinamide riboside (NIAGEN®) prevents the progression of peripheral sensory neuropathy in patients receiving infusions of paclitaxel or nab-paclitaxel for the treatment of metastatic breast cancer or recurrent platinum-resistant ovarian, endometrial, peritoneal, fallopian tube cancer or metastatic head and neck cancer.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nicotinamide Riboside
Capsule

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Donna Hammond, PhD ChromaDex, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (23)

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Outcome

Type Measure Description Time frame Safety issue
Other Difference in Total Neuropathy Score Between Screening and End of Treatment Exploratory analysis of ability of the clinical version of the Total Neuropathy Score questionnaire to detect changes in CIPN severity over time. Unlike the CTCAE or the FACT&GOG-NTX questionnaires, the TNS is a patient reported outcome measure. HIghest score (worse neuropathy is 24, lowest score is 0. Outcome assessed difference between end of treatment and screening. A positive number indicates improvement in neuropathy 4 weeks
Primary Number of Participants With No Worsening in the Grade of Peripheral Sensory Neuropathy as Scored by CTCAE The primary outcome variable is defined as no worsening of the grade of peripheral sensory neuropathy as scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 guidelines. Per the CTCAE a score of 1 would be assigned in the instance of parethesias or a loss of deep tendon reflexes. A score of 2 would be assigned in the instance of moderate symptoms that limit instrumental activities of daily living. A score of 3 would be assigned in the instance of severe symptoms that limit self-care activities of daily living. Because the outcome measure is defined as no worsening of the grade, it was recorded as either "yes"( i.e. it worsened) or "no" (i.e. it did not worsen). approximately 4 weeks
Secondary Percentage of Patients in Which Dose of Paclitaxel or Nab-Paclitaxel is Reduced Due to CIPN Quantitate the percentage of patients that experience a dose reduction of paclitaxel or nab-paclitaxel therapy due to neuropathy. 3 weeks
Secondary Number of Dose Reduction Events Count the number of (i.e. the incidence) of dose reduction events due to neuropathy (each occasion of dose reduction is a separate event); 3 weeks
Secondary Total Dose of Paclitaxel Administered Quantitate the total cumulative dose of paclitaxel administered over the 12 weeks. 3 weeks
Secondary Difference in Score Between Baseline and End of Treatment for the FACT&GOG-NTX Subscale . Difference in Score on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity questionnaire at the end of treatment; i.e. Score at screening - score at end of treatment. This questionnaire asks 11 questions that are specific to chemotherapy-induced peripheral neuropathies. Maximum score is 44, minimum score is 0. Positive differences indicate a decrease in neuropathy. Negative differences indicate a worsening of neuropathy. Zero means unchanged. 4 weeks
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