Fucoidan (seaweed) supplement for cancer survivors with fatigue

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

This study will try an 8-week fucoidan (seaweed) supplement to see if it reduces fatigue and inflammation in adult cancer survivors who finished treatment within the last 10 years.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Rochester (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Rochester, New York)
• Trial ID: NCT06295588 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional study tests an 8-week fucoidan supplement in adult cancer survivors who report clinically significant fatigue. Participants at the University of Rochester receive fucoidan extracted from Fucus vesiculosus or Undaria pinnatifida and follow a fixed dosing and delivery schedule while completing questionnaires and clinic visits. Investigators will measure changes in self-reported fatigue, frailty measures, and blood markers of inflammation before and after the intervention and will track feasibility outcomes such as adherence and tolerability. Eligible participants are English-speaking adults who completed surgery, radiation, or systemic anticancer therapy within the past 10 years and report a worst-week fatigue score of 4 or higher.

Who should consider this trial

Good fit: Adult (≥18) cancer survivors who completed definitive cancer treatments within the past 10 years, speak English, report a worst-week fatigue score ≥4, and can comply with the 8-week dosing and study visits are ideal candidates.

Not a fit: Patients taking anticoagulants, people already using fucoidan supplements, those with a fucoidan allergy, pregnant or nursing individuals, and those with recent major psychiatric hospitalization or dementia are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, the supplement could reduce fatigue and inflammation and improve physical function and quality of life for some cancer survivors.

How similar studies have performed: Small clinical and preclinical studies suggest anti-inflammatory and immune-modulating effects of fucoidan, but clinical evidence for reducing cancer-related fatigue is limited and this application is relatively novel.

Eligibility criteria

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

Where this trial is running

Rochester, New York

• University of Rochester Medical Center — Rochester, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Jeremy McGuire, PhD

Conditions: Fatigue, Inflammation, cancer-related fatigue