Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

NCT ID: NCT06295588

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-26

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Fatigue Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fucoidan

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

Group Type EXPERIMENTAL

Fucoidan extracted from F. Vesiculosus

Intervention Type DRUG

4 g daily

Usual Care

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

Group Type ACTIVE_COMPARATOR

Fucoidan extracted from U. Pinnatifida

Intervention Type DRUG

4 g daily

Interventions

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Fucoidan extracted from F. Vesiculosus

4 g daily

Intervention Type DRUG

Fucoidan extracted from U. Pinnatifida

4 g daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Responsible Party

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Jeremy J McGuire

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeremy McGuire, PhD

Role: CONTACT

5852740472

Facility Contacts

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Jeremy McGuire, PhD

Role: primary

5852740472

Jeremy McGuire

Role: backup

Other Identifiers

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T32CA102618

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009135

Identifier Type: -

Identifier Source: org_study_id

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