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Fucoidan for Preventing Chemotherapy-Related Fatigue in GI or Gynecological Cancer

This study is looking at whether a dietary supplement called fucoidan can help prevent fatigue caused by chemotherapy in patients with gastrointestinal (stomach, bowel, etc.) or gynecological (female reproductive system) cancer. Fucoidan is a natural substance found in brown seaweed, thought to have anti-inflammatory effects. You might be able to join if you are 18 or older, have a good performance status (meaning you can do most daily activities), and are starting certain types of chemotherapy for your cancer. The main goal is to see how much your fatigue changes over 8 weeks. This study is currently recruiting a small number of participants, with a planned enrollment of 34 people.

Study design
This is an interventional study that will randomize 34 participants to receive either fucoidan or a placebo (an inactive substance) for 8 weeks, then switch to the other treatment for another 8 weeks.
What's involved
You would take fucoidan or a placebo by mouth three times a day for 8 weeks, then switch to the other treatment for another 8 weeks. You would also have blood samples collected and complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your fatigue levels will be measured from the start of the study up to 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06855524

Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients With Gastrointestinal or Gynecological Cancer

Recruiting
PHASE2Ages 18+InterventionalPrevention
Mayo Clinic
~34 participants
Updated 2026-02-24 on ClinicalTrials.gov
What's tested:Biospecimen CollectionOligo-fucoidanPlacebo AdministrationQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in fatigue, weeks 1-8
Measured over Baseline to 8 weeks

Conditions

Malignant Digestive System Neoplasm
Malignant Female Reproductive System Neoplasm

Explore related trials

Malignant Digestive System NeoplasmMalignant Female Reproductive System Neoplasm

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Zoey I. Harris, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
Starting platinum-based doublet/triplet therapy for gynecologic or gastrointestinal cancer in the non-curative setting, with at least 16 weeks of chemotherapy and/or immunotherapy planned prior to registration; able to start study treatment ≤ 7 days prior to starting chemotherapy
Life expectancy at least 6 months
Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to registration)
Creatinine ≤ 1.5 x upper normal limit (UNL) OR calculated creatinine clearance ≥ 50 ml/min using the Cockcroft-Gault (obtained ≤ 30 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 1.5 x UNL; \[≤ 5 x upper limit of normal (ULN) for patients with liver involvement\] (obtained ≤ 30 days prior to registration)
Ability to complete patient questionnaires alone or with assistance and to be willing to be contacted by study staff
Provide written informed consent
Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Willing to use a highly effective method of contraception from the first dose of study medication through 30 days after the last dose of study medication, for persons of childbearing potential or persons able to father a child only
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Exclusion

Known hypersensitivity to fucoidan or seaweed products
Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 1 month prior to registration and plans to continue such for 8 weeks. Exercise is allowed
Psychiatric disorder such as untreated/uncontrolled depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (defined per medical history)
Surgery that required general anesthetic ≤ 4 weeks prior to registration
Malnutrition, active infection, severe depression, significant pulmonary disease, and/or cardiovascular disease that the attending physician feels could be causing the patient's fatigue
Use of any over-the-counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing ginseng, rhodiola rosea, guarana, or anything called an "adaptogen"), including current use of fucoidan
Current use of warfarin, heparin, enoxaparin, or a novel anticoagulant or known bleeding disorder/abnormal prothrombin time (PT)/partial thromboplastin time (PTT) at baseline
Current use of bevacizumab
Untreated thyroid conditions
Use of chemotherapy and/or immunotherapy ≤ 90 days prior to registration
Unwillingness to follow study related procedures
Inability to provide informed consent

What this trial measures

  • Change in fatigue, weeks 1-8Baseline to 8 weeks

    Will be assessed using self-reported fatigue over the past week. Fatigue is rated on a scale of 0-10 where 0=no fatigue at all and 10=fatigue as bad as it can be. Fatigue scores will be compared between arms.