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Trial Title: Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

NCT ID: NCT06295588

Condition: Fatigue
Inflammation

Conditions: Official terms:
Inflammation
Fatigue
Fucoidan

Conditions: Keywords:
cancer-related fatigue

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Dietary Supplement
Intervention name: Fucoidan extracted from F. Vesiculosus
Description: 4 g daily
Arm group label: Fucoidan

Intervention type: Dietary Supplement
Intervention name: Fucoidan extracted from U. Pinnatifida
Description: 4 g daily
Arm group label: Usual Care

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Rochester Medical Center

Address:
City: Rochester
Zip: 14642
Country: United States

Start date: December 1, 2024

Completion date: April 15, 2026

Lead sponsor:
Agency: University of Rochester
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Rochester

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06295588

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