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New treatment option for Malignant Digestive System Neoplasm
Official title Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients With Gastrointestinal or Gynecological Cancer
ClinicalTrials.gov ID: NCT06855524
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Life expectancy at least 6 months
- Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to registration)
You likely can't join if
- Known hypersensitivity to fucoidan or seaweed products
- Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants...
- Psychiatric disorder such as untreated/uncontrolled depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (defined...
- 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...
- Use of any over-the-counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing ginseng, rhodiola rosea...
See the full eligibility criteria
- 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...
- 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...
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.