Fucoidan Supplements for Fatigue in Cancer Survivors

Overseen By Jeremy McGuire, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Anticoagulants, Fucoidan supplements

Disqualifiers: Psychiatric illness, Dementia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fucoidan supplements can reduce fatigue in cancer survivors. Fucoidan, a natural compound found in seaweed, will be taken daily by participants or introduced after their usual care. Researchers aim to determine if these supplements can also improve frailty and inflammation. Individuals who completed cancer treatment in the last 10 years and experience significant tiredness may be suitable candidates. Participants must commit to the supplement routine and attend all study visits. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking warfarin or other anti-coagulation medications and any supplements that contain fucoidan.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that fucoidan is generally safe for use. In studies, individuals who took fucoidan daily for up to a year tolerated it well, with most not experiencing serious side effects. One study found that fucoidan might even help reduce tiredness and diarrhea in cancer patients, suggesting it is not only safe but may also offer additional benefits.

This trial uses fucoidan from two sources: Fucus vesiculosus and Undaria pinnatifida. Previous research has shown these types to be safe, with no major negative effects reported. Although this trial remains in its early stages, existing evidence suggests that participants should tolerate fucoidan well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for fatigue?

Unlike traditional treatments for fatigue in cancer survivors, which often focus on lifestyle changes or medications, fucoidan is derived from seaweed and has a unique approach. Researchers are excited about fucoidan because it contains bioactive compounds that may boost the immune system and reduce inflammation, potentially leading to improved energy levels. Additionally, fucoidan's natural source and potential antioxidant properties offer a promising alternative to conventional therapies, which may have more side effects.

What evidence suggests that fucoidan supplements might be an effective treatment for fatigue in cancer survivors?

This trial will compare the effects of fucoidan supplements on fatigue in cancer survivors. Research has shown that fucoidan, a substance from brown seaweed like Fucus vesiculosus and Undaria pinnatifida, may benefit cancer survivors. Participants in one arm of this trial will receive fucoidan extracted from F. vesiculosus, while those in the other arm will initially receive usual care followed by fucoidan extracted from U. pinnatifida. Studies have found that fucoidan can lessen tiredness and weakness, common after cancer treatment, by reducing inflammation and improving overall health. The FDA considers fucoidan safe to consume. Early research suggests it might enhance the quality of life for those experiencing fatigue after treatment. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for cancer survivors who are experiencing fatigue after their treatment. Participants should be interested in trying a seaweed supplement called fucoidan for 8 weeks to see if it helps reduce their tiredness and inflammation.

Inclusion Criteria

Speak and understand English

Completed Informed Consent

I finished my cancer treatment less than 10 years ago.

Exclusion Criteria

Any allergy to fucoidan

Be diagnosed with a major psychiatric illness requiring hospitalization within the last year

Be diagnosed with dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 grams daily of fucoidan for 8 weeks

8 weeks

Usual Care

Participants receive usual care for 8 weeks followed by 4 grams daily of fucoidan for another 8 weeks

16 weeks

Follow-up

Participants are monitored for changes in fatigue, frailty, and inflammation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fucoidan

Trial Overview The study is testing two types of fucoidan supplements, one from U. Pinnatifida seaweed and another from F. Vesiculosus, to evaluate their effectiveness in alleviating post-treatment fatigue and reducing signs of frailty and inflammation in cancer survivors.

How Is the Trial Designed?

Group I: Fucoidan Experimental Treatment 1 Intervention

They will receive 4 grams daily of fucoidan extracted from F. Vesiculosus for 8 weeks.

Group II: Usual Care Active Control 1 Intervention

They will receive usual care for 8 weeks followed by 4 grams daily of fucoidan extracted from U. Pinnatifida for 8 weeks.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A 12-week remote Fatigue Reduction Diet (FRD) intervention for diffuse large B-cell lymphoma (DLBCL) survivors was feasible and well-accepted, with 90% of participants attending all sessions.

Participants showed significant improvements in diet quality and a reduction in cancer-related fatigue, indicating that dietary interventions may be effective in enhancing the quality of life for lymphoma survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote Whole Food Dietary Intervention to Reduce Fatigue and Improve Diet Quality in Lymphoma Survivors: Results of a Feasibility Pilot Study. Weinhold, KR., Light, S., Bittoni, AM., et al.[2023]

In a study of 633 breast cancer survivors, higher levels of inflammation (measured by C-reactive protein) were associated with increased fatigue, indicating that inflammation may contribute to fatigue in these individuals.

The research found that a higher intake of ω-6 polyunsaturated fatty acids (PUFAs) relative to ω-3 PUFAs was linked to greater inflammation and fatigue, suggesting that increasing ω-3 PUFA intake could potentially help reduce fatigue in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue, inflammation, and ω-3 and ω-6 fatty acid intake among breast cancer survivors. Alfano, CM., Imayama, I., Neuhouser, ML., et al.[2022]

Cancer-related fatigue (CRF) can persist for years in cancer survivors, and nutritional interventions may help alleviate this fatigue by addressing inflammation and improving body composition.

Dietary patterns like the Mediterranean diet, increased protein intake, and supplements such as ginseng and probiotics have shown potential in reducing fatigue and improving energy levels in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Interventions for Treating Cancer-Related Fatigue: A Qualitative Review. Inglis, JE., Lin, PJ., Kerns, SL., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9140503/

Effectiveness of Fucoidan on Supplemental Therapy in ... The survival time is an important index of cancer treatment outcomes [23]. ... Undaria pinnatifida and their in vitro anticancer activity. Food ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5950942/

The Effect of Undaria pinnatifida Fucoidan on ... Fucoidans are a group of sulfated carbohydrates derived from marine brown algae (eg, Fucus vesiculosus, Cladosiphon okamuranus, Laminaria japonica, and Undaria ...

3. withpower.com withpower.com/trial/phase-inflammation-3-2024-6a8bd

Fucoidan Supplements for Fatigue in Cancer Survivors Pinnatifida seaweed and another from F. Vesiculosus, to evaluate their effectiveness in alleviating post-treatment fatigue and reducing signs of frailty and ...

4. cancerci.biomedcentral.com cancerci.biomedcentral.com/articles/10.1186/s12935-020-01233-8

The anti-cancer effects of fucoidan: a review of both in vivo ... ... fucoidan seems more effective [51]. Boo et al. once cultured PC-3, human prostate cancer cell, with fucoidan extracted from Undaria pinnatifida.

5. mdpi.com mdpi.com/1660-3397/21/5/307

Ten Years of Research on Fucoidan and Cancer Fucoidans from Fucus vesiculosus and Undaria pinnatifida are recognized as GRAS (Generally Recognized As Safe) by the USA Food and Drug Administration (FDA) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5739145/

Preclinical Evaluation of Safety of Fucoidan Extracts ... The overall objective in this study was to determine the safety of Undaria pinnatifida and Fucus vesiculosus to support potential evaluation in prospective ...

7. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Fucoidan-Cognitive-Vitality-For-Researchers.pdf

Fucoidan In addition, these reports include evaluation of safety data, from clinical trials if available, and from preclinical models. ... (2016) The Effect of Undaria ...