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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