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

NCT06855524 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC231007NCI-2025-0133424-004592
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Malignant Digestive System Neoplasm; Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change in fatigue, weeks 1-8

  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.

  Baseline to 8 weeks

Secondary Outcomes (4)

• Change in fatigue, weeks 9-16

  Baseline to 16 weeks

• Change in the symptoms

  Baseline to 16 weeks

• Change in Subjective Global Impression of Change scores

  Week 8 and Week 16

• Incidence of rates of symptoms

  Up to 16 weeks

Study Arms (2)

Arm 1 (fucoidan)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Dietary Supplement: Oligo-fucoidan; Other: Questionnaire Administration

Arm 2 (placebo)

PLACEBO COMPARATOR

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.

Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm 1 (fucoidan); Arm 2 (placebo)

Oligo-fucoidan DIETARY_SUPPLEMENT

Given PO

Also known as: Low-molecular-weight Fucoidan, Oligo Fucoidan

Arm 1 (fucoidan)

Placebo Administration DRUG

Given PO

Arm 2 (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (fucoidan); Arm 2 (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Zoey I. Harris, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Research staff, other than pharmacy, are blinded and will dispense the fucoidan or placebo to the patient at the site.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 6, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)