This phase II trial tests the feasibility of giving two different seaweed supplements called fucoidan to minimize fatigue and inflammation for cancer survivors. Fucoidan is a substance found in different species of algae. Fucoidan extracted from different species of algae have different structures and may act in different ways in the human body. Two of the common fucoidans used are Fucus vesiculosus and Undaria pinnatifida. Fucoidan may minimize fatigue and inflammation for cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06295588.
Locations matching your search criteria
United States
New York
Rochester
Pluta Cancer CenterStatus: Active
Contact: Jeremy J. McGuire
University of RochesterStatus: Active
Contact: Jeremy J. McGuire
Phone: 585-274-0472
PRIMARY OBJECTIVE:
I. To determine the feasibility of a fucoidan intervention in patients with fatigue post cancer treatment.
SECONDARY OBJECTIVES:
I. To determine effect size needed to evaluate if fucoidan alleviates fatigue in patients post cancer treatment.
II. To determine effect size needed to evaluate if fucoidan reduces inflammation markers, (plasma viscosity [PV], erythrocyte sedimentation rate [ESR], thyroid stimulating hormone [TSH], C-reactive protein [CRP], leptin, tumor necrosis factor [TNF] alpha, neopterin, lactate dehydrogenase [LD], D Dimer [DD and procalcitonin).
III. To determine the effect size needed to evaluate if fucoidan reduces symptoms of frailty in patients post cancer treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive Fucus vesiculosus fucoidan orally (PO) twice daily (BID) for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
ARM 2: Patients receive usual care for 8 weeks then receive Undaria pinnatifida fucoidan PO BID in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Rochester
Principal InvestigatorJeremy J. McGuire