NR in Chemo-induced Peripheral Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03642990|
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Peripheral Neuropathy Breast Cancer Metastatic||Drug: Nicotinamide Riboside||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects with stage IV breast cancer will receive 300 mg NIAGEN®) daily for one week followed by dose escalation to 1000 mg daily for 11 weeks upon reporting the development of grade 1 sensory neuropathy. Those presenting with a residual sensory neuropathy of ≤ 2 as a result of prior chemotherapy will also be enrolled.|
|Masking:||None (Open Label)|
|Official Title:||Nicotinamide Riboside (NR) in Paclitaxel-induced Peripheral Neuropathy|
|Actual Study Start Date :||February 22, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||April 2022|
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.
Drug: Nicotinamide Riboside
Other Name: NIAGEN®)
- Grade of CIPN as determined by the CTCAE v 4.03 [ Time Frame: approximately 14 weeks ]The primary outcome variable is binary (yes/no), and defined as no worsening of the grade of peripheral sensory neuropathy, scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 guidelines.
- Percentage of Patients in which Dose of Paclitaxel in Reduced due to CIPN [ Time Frame: 12 weeks ]Quantitate the percentage of patients that experience a dose reduction of paclitaxel therapy due to neuropathy;
- Number of Dose Reduction Events [ Time Frame: 12 weeks ]Count the number of (i.e. the incidence) of dose reduction events due to neuropathy (each occasion of dose reduction is a separate event);
- Total Dose of Paclitaxel Administered [ Time Frame: 12 weeks ]Quantitate the total cumulative dose of paclitaxel administered over the 12 weeks.
- Score on FACT&GOG-NTX subscale [ Time Frame: 14 weeks ]Score on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity questionnaire. This questionnaire asks 11 questions that are specific to chemotherapy-induced peripheral neuropathies.
- Total Neuropathy Score [ Time Frame: 14 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642990
|Contact: Donna L Hammond, PhDemail@example.com|
|Contact: Marian K Andersen, MSfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Donna L Hammond, PhD 319-335-9595 email@example.com|
|Contact: Marian K Anderson, MA 319-353-4578 firstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest University||Not yet recruiting|
|Salem, North Carolina, United States, 27109|
|Contact: Alexandra Thomas, MD 336-716-7217 email@example.com|
|Principal Investigator:||Donna L Hammond, PhD||University of Iowa|
|Principal Investigator:||Alexandra Thomas, MD||Wake Forest Unviersity|