Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

Minimizing Fatigue and Inflammation in Survivors of Cancer: A Pilot Randomized Clinical Trial of the Seaweed Supplement Fucoidan

To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Fatigue
• Intervention / Treatment: Dietary supplement: Fucoidan extracted from F. Vesiculosus; Dietary supplement: Fucoidan extracted from U. Pinnatifida

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy McGuire, PhD; Email: jeremy_mcguire@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Survivors of cancer
• Age 18 or older
• Speak and understand English
• Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment.
• Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
• Be willing to commit to the fucoidan supplement dosing and delivery method, to complete evaluation instruments, and to attend all study visits.
• Completed Informed Consent

Exclusion Criteria:

• Current warfarin or other anti-coagulation medication use.
• Current use of supplements that contain fucoidan
• Any allergy to fucoidan
• Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
• Be diagnosed with dementia.
• Be pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fucoidan; They will receive 4 grams daily of fucoidan extracted from F. Vesiculosus for 8 weeks.	Dietary supplement: Fucoidan extracted from F. Vesiculosus; 4 g daily
Active Comparator: Usual Care; They will receive usual care for 8 weeks followed by 4 grams daily of fucoidan extracted from U. Pinnatifida for 8 weeks.	Dietary supplement: Fucoidan extracted from U. Pinnatifida; 4 g daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of participants who are randomized to the study out of all participants approached	8 weeks
percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention	16 weeks
percentage of participants who take at least 80% of the fucoidan pills during the study	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean change in Brief Fatigue Inventory	The Brief Fatigue Inventory is a 9-item questionnaire that ranges from 0 to 10 with higher scores indicating a worse outcome.	baseline to 16 weeks
mean change in plasma viscosity in blood		baseline to 16 weeks
mean change in erythrocyte sedimentation rate in blood		baseline to 16 weeks
mean change in thyroid stimulating hormone in blood		baseline to 16 weeks
mean change in C-reactive protein in blood		baseline to 16 weeks
mean change in leptin in blood		baseline to 16 weeks
mean change in D Dimer in blood		baseline to 16 weeks
mean change in TNF alpha in blood		baseline to 16 weeks
mean change in neopterin in blood		baseline to 16 weeks
mean change in lactase dehydrogenase in blood		baseline to 16 weeks
mean change in procalcitonin in blood		baseline to 16 weeks
mean change in frailty using a modified Fried's Frailty questionnaire	The modified Fried's Frailty questionnaire measures self-reported slowness, weakness, weight loss, physical activity and fatigue. The total score of the questionnaire ranges from 1 to 5 with higher numbers indicating worse outcome.	baseline to 16 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cancer-related fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Fatigue; Inflammation; Antineoplastic Agents; Gastrointestinal Agents; Anticoagulants; Anti-Ulcer Agents; Fucoidan
• Other Study ID Numbers: STUDY00009135; T32CA102618 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No