Recruiting
Phase 2

Fucoidan

Sponsor:

University of Rochester

Code:

NCT06295588

Conditions

Fatigue

Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fucoidan extracted from F. Vesiculosus

Fucoidan extracted from U. Pinnatifida

Study Details

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

Study ID

NCT06295588

Start date

Jul 26, 2025

Status verified date

Nov, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fucoidan

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

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.

Interventions

Fucoidan extracted from F. Vesiculosus

4 g daily

Fucoidan extracted from U. Pinnatifida

4 g daily

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jeremy McGuire, PhD

5852740472jeremy_mcguire@urmc.rochester.edu

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Jeremy McGuire, PhD

5852740472Jeremy_McGuire@urmc.rochester.edu

Principal Investigator:

Jeremy McGuire, PhD

More Information

Sponsor

University of Rochester

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • cancer-related fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-11-26.