Recruiting NCT06295588
Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fucoidan extracted from F. Vesiculosus, Fucoidan extracted from U. Pinnatifida.
- Who it may be relevant to
- Registry conditions: Fatigue, Inflammation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Minimizing Fatigue and Inflammation in Survivors of Cancer: A Pilot Randomized Clinical Trial of the Seaweed Supplement Fucoidan
Overview
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.
Interventions
- Drug Fucoidan extracted from F. Vesiculosus
4 g daily - Drug Fucoidan extracted from U. Pinnatifida
4 g daily
Primary outcome measures
- percentage of participants who are randomized to the study out of all participants approached [Time frame: 8 weeks]
- percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention [Time frame: 16 weeks]
- percentage of participants who take at least 80% of the fucoidan pills during the study [Time frame: 8 weeks]
Secondary outcome measures (12)
- mean change in Brief Fatigue Inventory [Time frame: baseline to 16 weeks]
- mean change in plasma viscosity in blood [Time frame: baseline to 16 weeks]
- mean change in erythrocyte sedimentation rate in blood [Time frame: baseline to 16 weeks]
- mean change in thyroid stimulating hormone in blood [Time frame: baseline to 16 weeks]
- mean change in C-reactive protein in blood [Time frame: baseline to 16 weeks]
- mean change in leptin in blood [Time frame: baseline to 16 weeks]
- mean change in D Dimer in blood [Time frame: baseline to 16 weeks]
- mean change in TNF alpha in blood [Time frame: baseline to 16 weeks]
- mean change in neopterin in blood [Time frame: baseline to 16 weeks]
- mean change in lactase dehydrogenase in blood [Time frame: baseline to 16 weeks]
- mean change in procalcitonin in blood [Time frame: baseline to 16 weeks]
- mean change in frailty using a modified Fried's Frailty questionnaire [Time frame: baseline to 16 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT06295588 · STUDY00009135 · T32CA102618