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

Inclusion Criteria:

• Age ≥ 18 years

• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1

• Starting platinum-based doublet/triplet therapy for gynecologic or gastrointestinalcancer in the non-curative setting, with at least 16 weeks of chemotherapy and/orimmunotherapy planned prior to registration; able to start study treatment ≤ 7 daysprior 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 ≥ 50ml/min using the Cockcroft-Gault (obtained ≤ 30 days prior to registration)

• Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 1.5 x UNL; [≤ 5 xupper limit of normal (ULN) for patients with liver involvement] (obtained ≤ 30 daysprior to registration)

• Ability to complete patient questionnaires alone or with assistance and to bewilling to be contacted by study staff

• Provide written informed consent

• Negative pregnancy test done ≤ 7 days prior to registration, for persons ofchildbearing potential only NOTE: If the urine test is positive or cannot beconfirmed as negative, a serum pregnancy test will be required

• Willing to use a highly effective method of contraception from the first dose ofstudy medication through 30 days after the last dose of study medication, forpersons of childbearing potential or persons able to father a child only

• Willing to return to enrolling institution for follow-up (during the ActiveMonitoring Phase of the study)

Exclusion Criteria:

• Known hypersensitivity to fucoidan or seaweed products

• Currently using any other pharmacologic agents to specifically treat fatigueincluding psychostimulants or antidepressants. Note: Antidepressants used to treatitems other than fatigue (such as hot flashes or depression) are allowed if thepatient has been on a stable dose for ≥ 1 month prior to registration and plans tocontinue such for 8 weeks. Exercise is allowed

• Psychiatric disorder such as untreated/uncontrolled depression, manic depressivedisorder, obsessive compulsive disorder or schizophrenia (defined per medicalhistory)

• 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 causingthe 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 anythingcalled an "adaptogen"), including current use of fucoidan

• Current use of warfarin, heparin, enoxaparin, or a novel anticoagulant or knownbleeding 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