Recruiting
Phase 2

Fucoidan

Sponsor:

Mayo Clinic

Code:

NCT06855524

Conditions

Malignant Digestive System Neoplasm

Malignant Female Reproductive System Neoplasm

Breast Carcinoma

Lung Carcinoma

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Oligo-fucoidan

Placebo Administration

Questionnaire Administration

Study Details

Brief summary:

This phase II trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI), gynecological (GYN), breast, or lung 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, GYN, breast, or lung cancer.

Conditions

Malignant Digestive System Neoplasm

Malignant Female Reproductive System Neoplasm

Breast Carcinoma

Lung Carcinoma

Malignant Solid Neoplasm

Study ID

NCT06855524

Start date

Mar 6, 2025

Status verified date

Oct, 2026

Completion date

Jan 28, 2029

Anticipated

Primary completion date

Jan 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm 1 (fucoidan)

Patients receive fucoidan PO TID for 8 weeks. After completion of fucoidan, patients then cross over into Arm 2 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.

placebo comparator: Arm 2 (placebo)

Patients receive placebo PO TID for 8 weeks. After completion of placebo, patients then cross over into Arm 1 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Oligo-fucoidan

Given PO

Placebo Administration

Given PO

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Change in fatigue, weeks 1-8 [ Time Frame: Baseline to 8 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Zoey I. Harris, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.