Actively Recruiting
Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients With Gastrointestinal or Gynecological Cancer
Led by Mayo Clinic · Updated on 2026-02-24
34
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI) or gynecological (GYN) cancer. Fatigue poses a burden in patients with malignancies undergoing systemic chemotherapy. Fucoidan is a dietary supplement made of complex sugar that contain sulfate groups attached to their sugar units (sulfated polysaccharide) which found in brown seaweed. It is thought to have anti-inflammatory, anti-viral, anti-thrombotic, anti-diabetic, and anti-tumor effects in pre-clinical models. Giving fucoidan may be effective in preventing chemotherapy-related fatigue in patients with GI or GYN.
CONDITIONS
Official Title
Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients With Gastrointestinal or Gynecological Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0 or 1
- Starting platinum-based doublet or triplet chemotherapy for gynecologic or gastrointestinal cancer in a non-curative setting
- Planned chemotherapy and/or immunotherapy for at least 16 weeks before registration
- Able to start study treatment within 7 days before chemotherapy begins
- Life expectancy of at least 6 months
- Hemoglobin level at least 10 g/dL within 30 days before registration
- Creatinine level no higher than 1.5 times the upper normal limit or creatinine clearance at least 50 ml/min within 30 days before registration
- ALT and AST levels no higher than 1.5 times the upper normal limit (or no higher than 5 times for patients with liver involvement) within 30 days before registration
- Ability to complete patient questionnaires alone or with help and willingness to be contacted by study staff
- Provide written informed consent
- Negative pregnancy test within 7 days before registration for persons who can become pregnant
- Willingness to use highly effective contraception from first dose through 30 days after last dose for persons who can become pregnant or father a child
- Willingness to return to the study site for follow-up during active monitoring phase
You will not qualify if you...
- Known allergy to fucoidan or seaweed products
- Currently using medications specifically for fatigue such as psychostimulants or antidepressants (unless stable dose for other reasons for at least 1 month)
- Untreated or uncontrolled psychiatric disorders including depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia
- Surgery requiring general anesthesia within 4 weeks before registration
- Malnutrition, active infection, severe depression, significant lung disease, or heart disease that may cause fatigue
- Use of any herbal or dietary supplements marketed for fatigue or energy, including fucoidan
- Current use of blood thinners like warfarin, heparin, enoxaparin, or novel anticoagulants or known bleeding disorders
- Current use of bevacizumab
- Untreated thyroid conditions
- Receipt of chemotherapy or immunotherapy within 90 days before registration
- Unwillingness to follow study procedures
- Inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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