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OpenTrials
Active, not recruiting

NCT Number: NCT06295588

Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Fatigue Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Survivors of cancer
  • Age 18 or older
  • Speak and understand English
  • Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment.
  • Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
  • Be willing to commit to the fucoidan supplement dosing and delivery method, to complete evaluation instruments, and to attend all study visits.
  • Completed Informed Consent

Exclusion criteria

  • Current warfarin or other anti-coagulation medication use.
  • Current use of supplements that contain fucoidan
  • Any allergy to fucoidan
  • Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
  • Be diagnosed with dementia.
  • Be pregnant or nursing

Treatment and study plan

Fucoidan extracted from F. Vesiculosus

Drug

4 g daily

Fucoidan extracted from U. Pinnatifida

Drug

4 g daily

Primary outcomes

  1. percentage of participants who are randomized to the study out of all participants approached

    Time frame: 8 weeks

  2. percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention

    Time frame: 16 weeks

  3. percentage of participants who take at least 80% of the fucoidan pills during the study

    Time frame: 8 weeks

Secondary outcomes

  1. mean change in Brief Fatigue Inventory

    Time frame: baseline to 16 weeks

    The Brief Fatigue Inventory is a 9-item questionnaire that ranges from 0 to 10 with higher scores indicating a worse outcome.

  2. mean change in plasma viscosity in blood

    Time frame: baseline to 16 weeks

  3. mean change in erythrocyte sedimentation rate in blood

    Time frame: baseline to 16 weeks

  4. mean change in thyroid stimulating hormone in blood

    Time frame: baseline to 16 weeks

  5. mean change in C-reactive protein in blood

    Time frame: baseline to 16 weeks

  6. mean change in leptin in blood

    Time frame: baseline to 16 weeks

  7. mean change in D Dimer in blood

    Time frame: baseline to 16 weeks

  8. mean change in TNF alpha in blood

    Time frame: baseline to 16 weeks

  9. mean change in neopterin in blood

    Time frame: baseline to 16 weeks

  10. mean change in lactase dehydrogenase in blood

    Time frame: baseline to 16 weeks

  11. mean change in procalcitonin in blood

    Time frame: baseline to 16 weeks

  12. mean change in frailty using a modified Fried's Frailty questionnaire

    Time frame: baseline to 16 weeks

    The modified Fried's Frailty questionnaire measures self-reported slowness, weakness, weight loss, physical activity and fatigue. The total score of the questionnaire ranges from 1 to 5 with higher numbers indicating worse outcome.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Minimizing Fatigue and Inflammation in Survivors of Cancer: A Pilot Randomized Clinical Trial of the Seaweed Supplement Fucoidan

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2024
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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