Registration – Inclusion Criteria

• > 18 years of age.
• Any history of cancer-related fatigue will be allowed.
• ECOG performance score 0, 1.
• Starting platinum-based doublet/triplet therapy for stage 4 cancer, with at least 16 weeks of chemotherapy[DSDM1]  and/or immunotherapy planned at time of the first dose of this study’s oral product.
• Life expectancy at least 6 months.
• The following laboratory values obtained prior to randomization:
  • Hgb ≥ 10 (must be obtained ≤ 30 days; patients must not have been transfused in the preceding 30 days to meet this criterion)
  • Creatinine ≤ 1.5 x UNL (must be obtained ≤ 30 days prior to randomization
  • AST (SGOT) or ALT (SGPT) ≤ 1.5 x UNL (obtained ≤ 30 days prior to randomization); allow up to 5 x ULN if liver mets present.
• 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 (Appendix III) from the first dose of study medication through 180 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)
• Known hypersensitivity to fucoidan or seaweed products.

Registration - 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 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 in the 4 weeks prior to randomization.
• 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”).
• Current use of warfarin, heparin, enoxaparin, or a novel anticoagulant or known bleeding disorder.
• Current use of bevacizumab.
• Untreated thyroid conditions.
• Use of chemotherapy and/or immunotherapy within 90 days of starting the trial.
• Unwillingness to follow study related procedures.
• Inability to provide informed consent.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/19/2024. Questions regarding updates should be directed to the study team contact.