Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295588
• Other study ID #: STUDY00009135
• Secondary ID: T32CA102618
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: Jeremy McGuire, PhD
• Phone: 5852740472
• Email: jeremy_mcguire[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Inflammation

Intervention

Dietary Supplement:
• Fucoidan extracted from F. Vesiculosus
4 g daily
• Fucoidan extracted from U. Pinnatifida
4 g daily

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of participants who are randomized to the study out of all participants approached		8 weeks
Primary	percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention		16 weeks
Primary	percentage of participants who take at least 80% of the fucoidan pills during the study		8 weeks
Secondary	mean change in Brief Fatigue Inventory	The Brief Fatigue Inventory is a 9-item questionnaire that ranges from 0 to 10 with higher scores indicating a worse outcome.	baseline to 16 weeks
Secondary	mean change in plasma viscosity in blood		baseline to 16 weeks
Secondary	mean change in erythrocyte sedimentation rate in blood		baseline to 16 weeks
Secondary	mean change in thyroid stimulating hormone in blood		baseline to 16 weeks
Secondary	mean change in C-reactive protein in blood		baseline to 16 weeks
Secondary	mean change in leptin in blood		baseline to 16 weeks
Secondary	mean change in D Dimer in blood		baseline to 16 weeks
Secondary	mean change in TNF alpha in blood		baseline to 16 weeks
Secondary	mean change in neopterin in blood		baseline to 16 weeks
Secondary	mean change in lactase dehydrogenase in blood		baseline to 16 weeks
Secondary	mean change in procalcitonin in blood		baseline to 16 weeks
Secondary	mean change in frailty using a modified Fried's Frailty questionnaire	The modified Fried's Frailty questionnaire measures self-reported slowness, weakness, weight loss, physical activity and fatigue. The total score of the questionnaire ranges from 1 to 5 with higher numbers indicating worse outcome.	baseline to 16 weeks