Chemotherapy-induced Peripheral Neuropathy Clinical Trial
Official title:
Nicotinamide Riboside (NR) in Paclitaxel-induced Peripheral Neuropathy
Verified date | March 2023 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | February 24, 2022 |
Est. primary completion date | August 18, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Be able to give written informed consent and HIPAA authorization - Be 18 to 85 years old - Have been diagnosed with stage IV breast cancer of any type, platinum-resistant recurrent ovarian, peritoneal, endometrial, or fallopian tube cancer, or platinum-resistant recurrent or metastatic head and neck cancer and are anticipated to survive for at least three months - Have an ECOG Performance Status of 0-2 - Able to take medication orally - up to four capsules in the morning (am) and four capsules in the evening (pm). - Be undergoing infusions of paclitaxel or nab-paclitaxel for treatment of breast cancer, platinum-resistant recurrent ovarian, peritoneal, endometrial, or fallopian tube cancer, or platinum-resistant recurrent or metastatic head and neck cancer and be determined to have at least a grade 1 neuropathy based on the CTCAE version 4.03 guidelines for peripheral sensory neuropathy. Breast cancer patients may also be treated concomitantly with monoclonal antibodies to HER2 such as trastuzumab (Herceptin) and pertuzumab (Perjeta). Patients with platinum-resistant ovarian, peritoneal, endometrial, or fallopian tube cancer or platinum-resistant recurrent or metastatic head and neck cancer may also be treated concomitantly with a vascular endothelial growth receptor 2 inhibitor such as bevacizumab (Avastin) or a checkpoint inhibitor. - Females must be either postmenopausal for at least 1 year or surgically sterile for at least 6 weeks. Females of childbearing potential must have a negative pregnancy test at screening to be eligible for study participation, and agree to take appropriate precautions to avoid pregnancy from screening through follow-up. - Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up. The following methods have been determined to be more than 99% effective (<1% failure rate per year when used consistently and correctly) and are permitted under this protocol for use by the patient and his/her partner: - Complete abstinence from sexual intercourse when this is in line with the preferred and usual lifestyle of the patient - Double barrier methods including condom with spermicide in conjunction with use of an intrauterine device or condom with spermicide in conjunction with use of a diaphragm - Surgical sterilization (bilateral oopherectomy with or without hysterectomy, tubal ligation or vasectomy) at least 6 weeks prior to taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and/or estradiol. Non-hormonal intrauterine device used as directed by provider placing this is also acceptable. Exclusion Criteria: - Pre-existent peripheral neuropathy that is unrelated to chemotherapy - Pre-existent chemotherapy-induced peripheral neuropathy greater than grade 2 - Known metastases to the brain, spinal cord or peripheral nerves, or leptomeningeal disease - Concurrent administration of a poly (ADP-Ribose) polymerase inhibitor (e.g. olaparib, rucaparib) - Concurrent administration of a platinum-based chemotherapy - Diabetes requiring management by medication - Diabetes managed by medication - Neutrophils < 1,000 cells/m3 - Hemoglobin < 8.0 g/dcl - Platelets < 100,000 cells/m3 - Creatinine clearance < 30 ml/min - AST or ALT values > 2.5 X upper limits of normal - Total bilirubin > 2.0 X upper limits of normal - Heavy alcohol use defined at > 8 drinks/week by women or 12 drinks/week by men - Chronic pain greater than 3 months duration within the past year. - Severe psychiatric illness - Pregnancy - Current imprisonment - Limitations of self-expression, defined as an inability to answer questions posed by physicians, nurses, care-givers, or other members of the investigative team or an inability to describe somatosensations. - Known HIV, not on therapy - Regular use of nutritional supplements that contain nicotinamide or NIAGEN® within the previous 30 days - Use of duloxetine (Cymbalta®) within the previous 30 days - Pancreatic insufficiency requiring exocrine enzyme replacement therapy - GI conditions where malabsorption of B complex vitamins is known to occur. - Known allergy to Cremophor vehicle used to deliver paclitaxel in its Taxol formulation - Breastfeeding |
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 |
Lead Sponsor | Collaborator |
---|---|
Donna Hammond, PhD | ChromaDex, Inc., National Cancer Institute (NCI) |
United States,
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* Note: There are 23 references in all — Click here to view all references
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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