This phase IIb trial tests whether ergocalciferol (vitamin D2) works to improve neuropathic pain in patients with cancer undergoing taxane-based chemotherapy. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Peripheral neuropathy is a common side effect of taxane-based chemotherapies which can affect patient quality of life and treatment adherence. Taxanes are commonly used for the treatment of several types of cancers, including breast cancer, head and neck cancer, gynecological cancers and lung cancer. Vitamin D deficiency may be associated with an increased risk of taxane-induced neuropathy. Giving vitamin D may help prevent peripheral neuropathy in patients with cancer undergoing taxane-based chemotherapy.
Additional locations may be listed on ClinicalTrials.gov for NCT05259527.
Locations matching your search criteria
United States
Virginia
Richmond
VCU Massey Comprehensive Cancer CenterStatus: Temporarily closed to accrual
Contact: Susan Hong
Phone: 804-628-1931
PRIMARY OBJECTIVE:
I. To assess the preliminary efficacy of vitamin D replacement in reported rates of neuropathic pain associated with taxane-based chemotherapy.
SECONDARY OBJECTIVE:
I. To assess the preliminary efficacy of Vitamin D replacement in reported rates of neuropathic pain associated with taxane-based chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 arms. Patients with vitamin D levels >= 20ng/ml and/or calcium >= 10.5 mg/dL, are assigned to observational arm 3.
ARM I: Patients receive vitamin D2 orally (PO) once weekly for 8 weeks then once monthly thereafter. Patients also undergo blood sample collection on the study.
ARM II: Patients receive standard of care (SOC) consisting of notifying patient of vitamin D deficiency and recommending over-the-counter supplements on study. Patients also undergo blood sample collection on the study.
ARM III: Patients undergo observation on study.
After completion of study treatment, patients are followed up at 24 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationVCU Massey Comprehensive Cancer Center
Principal InvestigatorSusan Hong
