Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

University of Rochester

Status: Not yet enrolling

Conditions: Inflammation; Fatigue

Treatments: Dietary Supplement: Fucoidan extracted from F. Vesiculosus; Dietary Supplement: Fucoidan extracted from U. Pinnatifida

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06295588

T32CA102618 (U.S. NIH Grant/Contract)

STUDY00009135

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Fucoidan

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fucoidan extracted from F. Vesiculosus

Usual Care

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Fucoidan extracted from U. Pinnatifida