Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

NCT06295588 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: STUDY00009135T32CA102618
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Inflammation

Keywords

cancer-related fatigue

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• mean change in Brief Fatigue Inventory

  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

Study Arms (2)

Fucoidan

EXPERIMENTAL

They will receive 4 grams daily of fucoidan extracted from F. Vesiculosus for 8 weeks.

Drug: Fucoidan extracted from F. Vesiculosus

Usual Care

ACTIVE COMPARATOR

They will receive usual care for 8 weeks followed by 4 grams daily of fucoidan extracted from U. Pinnatifida for 8 weeks.

Drug: Fucoidan extracted from U. Pinnatifida

Interventions

Fucoidan extracted from F. Vesiculosus DRUG

4 g daily

Fucoidan

Fucoidan extracted from U. Pinnatifida DRUG

4 g daily

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Fatigue; Inflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Jeremy McGuire, PhD

CONTACT

5852740472; jeremy_mcguire@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: July 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)