Actively Recruiting
Fucoidan for Patients With Chemotherapy-Related Fatigue: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
Led by Mayo Clinic · Updated on 2026-02-24
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating fucoidan, a dietary supplement made from brown seaweed, to see if it can prevent fatigue caused by chemotherapy in patients with gastrointestinal or gynecological cancers. Fatigue is a common and challenging side effect for patients undergoing systemic chemotherapy. This phase 2, double-blind, randomized, placebo-controlled pilot study aims to compare fucoidan to a placebo in reducing chemotherapy-related fatigue and its effects on inflammatory markers. Participants are randomly assigned to one of two groups. One group receives fucoidan orally three times a day for 8 weeks, then switches to placebo for the next 8 weeks. The other group starts with placebo three times a day for 8 weeks, then crosses over to fucoidan for 8 weeks. Blood samples may be collected during screening and throughout the study to assess inflammatory markers and other biological factors. Participants will be assessed on their fatigue levels using a simple fatigue measure at the start, 8 weeks, and 16 weeks. Additional assessments include symptom diaries, global impression of change, and the Functional Assessment of Cancer Therapy-Fatigue subscale. Safety and side effects are monitored through patient-reported symptom diaries. The total participation covers 16 weeks of treatment with follow-up evaluations during this time.
CONDITIONS
Brief 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
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Starting platinum-based doublet or triplet therapy for gynecologic or gastrointestinal cancer in the non-curative setting
- Planned chemotherapy and/or immunotherapy for at least 16 weeks prior to registration
- Able to start study treatment no more than 7 days before starting chemotherapy
- Life expectancy of at least 6 months
- Hemoglobin level of at least 10 g/dL within 30 days prior to registration
- Creatinine level less than or equal to 1.5 times upper normal limit or creatinine clearance at least 50 ml/min within 30 days prior to registration
- ALT and AST levels less than or equal to 1.5 times upper normal limit (or less than or equal to 5 times upper limit for patients with liver involvement) within 30 days prior to 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 prior to registration for persons of childbearing potential
- Willingness to use highly effective contraception from first dose through 30 days after last dose for persons of childbearing potential or able to father a child
- Willingness to return to enrolling institution for follow-up during the Active Monitoring Phase
You will not qualify if you...
- Known allergy or hypersensitivity to fucoidan or seaweed products
- Currently using pharmacologic agents specifically to treat fatigue, such as psychostimulants or antidepressants (except stable doses for other indications)
- Psychiatric disorders such as untreated or uncontrolled depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia
- Surgery requiring general anesthesia within 4 weeks before registration
- Malnutrition, active infection, severe depression, significant lung or heart disease that may cause fatigue
- Use of over-the-counter supplements marketed for fatigue or energy, including fucoidan
- Current use of blood thinners like warfarin, heparin, enoxaparin, novel anticoagulants, or known bleeding disorders
- Current use of bevacizumab
- Untreated thyroid conditions
- Use of chemotherapy or immunotherapy within 90 days prior to registration
- Unwillingness or inability to follow study procedures or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive oral fucoidan or placebo three times a day for 8 weeks, then cross over to the alternate treatment for another 8 weeks.
Regular visits during treatment period
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here