RECRUITING

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

Talk to us

Conditions

Malignant Digestive System NeoplasmMalignant Female Reproductive System Neoplasm

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Fucoidan for Patients with Chemotherapy-Related Fatigue: a Double-Blind, Randomized, Placebo-Controlled Pilot Study

Quick Facts

Study Start:2025-03-06
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06855524

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
  3. * 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
  4. * Life expectancy at least 6 months
  5. * Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to registration)
  6. * 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)
  7. * 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)
  8. * Ability to complete patient questionnaires alone or with assistance and to be willing to be contacted by study staff
  9. * Provide written informed consent
  10. * 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
  11. * 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
  12. * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  1. * Known hypersensitivity to fucoidan or seaweed products
  2. * 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
  3. * Psychiatric disorder such as untreated/uncontrolled depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (defined per medical history)
  4. * Surgery that required general anesthetic ≤ 4 weeks prior to registration
  5. * Malnutrition, active infection, severe depression, significant pulmonary disease, and/or cardiovascular disease that the attending physician feels could be causing the patient's fatigue
  6. * 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
  7. * Current use of warfarin, heparin, enoxaparin, or a novel anticoagulant or known bleeding disorder/abnormal prothrombin time (PT)/partial thromboplastin time (PTT) at baseline
  8. * Current use of bevacizumab
  9. * Untreated thyroid conditions
  10. * Use of chemotherapy and/or immunotherapy ≤ 90 days prior to registration
  11. * Unwillingness to follow study related procedures
  12. * Inability to provide informed consent

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

John K. Camoriano, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • John K. Camoriano, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-06
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2025-03-06
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Digestive System Neoplasm
  • Malignant Female Reproductive System Neoplasm