Using fucoidan to prevent fatigue in cancer patients undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of fucoidan, a dietary supplement derived from brown seaweed, in preventing chemotherapy-related fatigue in patients with gastrointestinal or gynecological cancers. Participants are randomly assigned to receive either fucoidan or a placebo for 8 weeks, followed by a crossover to the alternate treatment. The study measures fatigue levels and other health indicators at specified intervals to assess the impact of fucoidan compared to placebo. Additionally, it explores changes in inflammatory markers associated with fatigue.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
* Starting platinum-based doublet/triplet therapy for gynecologic, gastrointestinal, breast, or lung 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 Criteria:

* 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

Where it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting

Study contacts

• Principal investigator: Zoey I. Harris, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.