Clinical trial NCT06295588: Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer
Official title: Minimizing Fatigue and Inflammation in Survivors of Cancer: A Pilot Randomized Clinical Trial of the Seaweed Supplement Fucoidan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue
Inflammation
Keywords: cancer-related fatigue
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: percentage of participants who are randomized to the study out of all participants approached
timeFrame: 8 weeks
measure: percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention
timeFrame: 16 weeks
measure: percentage of participants who take at least 80% of the fucoidan pills during the study
timeFrame: 8 weeks
Secondary outcomes:
measure: mean change in Brief Fatigue Inventory
timeFrame: baseline to 16 weeks
measure: mean change in plasma viscosity in blood
timeFrame: baseline to 16 weeks
measure: mean change in erythrocyte sedimentation rate in blood
timeFrame: baseline to 16 weeks
measure: mean change in thyroid stimulating hormone in blood
timeFrame: baseline to 16 weeks
measure: mean change in C-reactive protein in blood
timeFrame: baseline to 16 weeks
measure: mean change in leptin in blood
timeFrame: baseline to 16 weeks
measure: mean change in D Dimer in blood
timeFrame: baseline to 16 weeks
measure: mean change in TNF alpha in blood
timeFrame: baseline to 16 weeks
measure: mean change in neopterin in blood
timeFrame: baseline to 16 weeks
measure: mean change in lactase dehydrogenase in blood
timeFrame: baseline to 16 weeks
measure: mean change in procalcitonin in blood
timeFrame: baseline to 16 weeks
measure: mean change in frailty using a modified Fried's Frailty questionnaire
timeFrame: baseline to 16 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: