Fucoidan for Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Psychostimulants, Antidepressants, Anticoagulants, Bevacizumab

Disqualifiers: Hypersensitivity to seaweed, Untreated depression, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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. Fucoidan is a dietary supplement made of complex sugar that contain sulfate groups attached to their sugar units (sulfated polysaccharide) which found in brown seaweed. It is thought to have anti-inflammatory, anti-viral, anti-thrombotic, anti-diabetic, and anti-tumor effects in pre-clinical models. Giving fucoidan may be effective in preventing chemotherapy-related fatigue in patients with GI or GYN.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use certain fatigue treatments, some herbal supplements, or specific blood thinners. If you're on antidepressants for reasons other than fatigue, you can continue if you've been on a stable dose for at least a month.

What data supports the effectiveness of the treatment Fucoidan for cancer?

Fucoidan, a natural compound from brown seaweed, has shown potential in lab studies to slow down tumor growth and work well with existing cancer drugs. It also helps protect healthy cells from the side effects of chemotherapy and boosts the immune system, which could improve the quality of life for cancer patients. ^{1 2 3 4 5}

Is Fucoidan safe for use in humans?

There is no specific safety data on Fucoidan in the provided research articles, but natural products-based drugs, like Fucoidan, are generally considered safer than synthetic ones. However, some natural anticancer drugs can still have side effects, so comprehensive safety studies are needed. ^{6 7 8 9 10}

How is the treatment Fucoidan unique for cancer?

Fucoidan is unique for cancer treatment because it is a natural compound derived from brown seaweed that enhances the immune system's ability to fight cancer cells, has low toxicity, and can work alongside existing cancer therapies to improve their effectiveness. Unlike many traditional chemotherapy drugs, Fucoidan targets cancer cells while minimizing harm to healthy tissues. ^{2 3 4 11 12}

Research Team

John K. Camoriano, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients with gastrointestinal or gynecological cancer experiencing fatigue from chemotherapy. Participants should be undergoing systemic chemotherapy and willing to take a dietary supplement or placebo.

Inclusion Criteria

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

Life expectancy at least 6 months

Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to registration)

Exclusion Criteria

Known hypersensitivity to fucoidan or seaweed products

My thyroid condition has not been treated.

I am not taking medication for fatigue, but I may be on antidepressants for other reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either fucoidan or placebo orally three times a day for 8 weeks

8 weeks

Regular visits for monitoring

Crossover Treatment

Participants cross over to the alternate treatment arm for another 8 weeks

8 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Fucoidan

Trial Overview The study tests if fucoidan, a sulfated polysaccharide from brown seaweed, can prevent chemo-related fatigue compared to a placebo. It includes taking the supplement, answering questionnaires, and providing biospecimens.

Participant Groups

Group I: Arm 1 (fucoidan) Experimental Treatment 3 Interventions

Patients receive fucoidan PO TID for 8 weeks. After completion of fucoidan, patients then cross over into Arm 2 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.

Group II: Arm 2 (placebo) Placebo Group 3 Interventions

Patients receive placebo PO TID for 8 weeks. After completion of placebo, patients then cross over into Arm 1 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Fucoidans, natural compounds with various biological functions, have shown potential as supportive agents in cancer treatment due to their anti-inflammatory, immunostimulating, and anticoagulant properties, despite limited direct antitumor activity in clinical trials.

These compounds may enhance recovery after chemotherapy and radiation by promoting hematopoiesis, which could improve the quality of life for patients with advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives for the Use of Fucoidans in Clinical Oncology. Kiselevskiy, MV., Anisimova, NY., Ustyuzhanina, NE., et al.[2022]

Fucoidan, a natural compound from brown seaweed, shows anti-cancer properties by targeting key molecules involved in cell death, making it a potential adjunct to traditional chemotherapy.

In addition to its anti-cancer effects, fucoidan may help protect healthy tissues from the toxic side effects of chemotherapy and radiation, suggesting a synergistic benefit when used alongside standard cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fucoidan and cancer: a multifunctional molecule with anti-tumor potential. Atashrazm, F., Lowenthal, RM., Woods, GM., et al.[2023]

Fucoidan, a natural compound from brown seaweeds, has shown promising anticancer properties in laboratory studies, including the ability to inhibit tumor growth and angiogenesis, while also being low in toxicity.

The review emphasizes the need for in vivo studies using purified fucoidan in animal models to better understand its effectiveness and potential as a marine-derived anticancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fucoidan as a marine anticancer agent in preclinical development. Kwak, JY.[2021]

Fucoidans, extracted from brown seaweed, have shown a wide range of beneficial biological activities, particularly in enhancing the immune response and exhibiting strong antitumor properties, making them promising candidates for cancer immunotherapy.

Recent studies indicate that fucoidans can activate cytotoxic T lymphocytes (CTLs) against cancer cells and may be effectively used as adjuvants alongside existing immunotherapeutic treatments to improve patient outcomes in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunopotentiating Activity of Fucoidans and Relevance to Cancer Immunotherapy. Li, Y., McGowan, E., Chen, S., et al.[2023]

Fucoidan demonstrated significant cytotoxic effects on MCF-7 breast cancer cells, causing cell cycle arrest and apoptosis, while showing no harmful effects on non-cancerous MCF-12A cells, indicating its potential as a safe anticancer agent.

When combined with standard chemotherapy drugs like cisplatin, doxorubicin, and taxol, fucoidan enhanced their effectiveness against cancer cells, suggesting that it could be a valuable addition to cancer treatment regimens without increasing toxicity to healthy cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Fucoidan and Chemotherapeutic Agent Combinations on Malignant and Non-malignant Breast Cell Lines. Abudabbus, A., Badmus, JA., Shalaweh, S., et al.[2018]

A total of 9,649 adverse drug reactions (ADRs) were reported for antineoplastic and immunomodulating medications in the EU from 2007 to 2011, with about 15% classified as serious, including 26 deaths.

The majority of ADRs were reported by women (73%) and were primarily related to general disorders and administration site conditions (54%), indicating a significant consumer interest in reporting these reactions, although most were non-serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of antineoplastic and immunomodulating medications reported by European consumers. Aagaard, L., Hansen, EH.[2021]

A survey of 112 international stakeholders in dose-finding oncology trials revealed that most had little experience with patient-reported outcomes (PROs), but there was strong support for their use to identify and assess the frequency and duration of adverse events.

Stakeholders identified key barriers to using PROs, including a lack of guidance on PRO selection and concerns about data completeness, highlighting the need for standardized guidelines to improve their implementation in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum. Lai-Kwon, J., Vanderbeek, AM., Minchom, A., et al.[2022]

A review of 209 lung cancer phase I and II trials presented at the American Society for Clinical Oncology meetings from 2017 to 2019 revealed significant variability in how adverse events (AEs) were reported, with six different thresholds for reporting AEs of any grade.

Treatment-related AEs were reported twice as often as treatment-emergent AEs, and there was a lack of clear definitions for critical terms like dose-limiting toxicity and serious AEs, highlighting the need for standardized reporting methods to improve data comparability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. Simons, EA., Smith, DE., Gao, D., et al.[2021]

Anti-CTLA-4 therapy (ipilimumab) is associated with a significantly higher risk of severe colitis compared to anti-PD-1 therapies (nivolumab and pembrolizumab), with a three-fold increase in adverse event reports related to colitis.

The study utilized a novel data analysis platform to explore the molecular mechanisms behind these adverse reactions, but found no significant evidence that the increased colitis rates were due to greater T-cell activation from anti-CTLA-4 therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of a patient-centered reverse translational systems-based approach to understand mechanisms of an adverse drug reaction of immune checkpoint inhibitors. Kim, S., Lahu, G., Vakilynejad, M., et al.[2022]

A systematic review of anticancer natural products revealed that many of these drugs, despite being considered safer than synthetic options, can still cause significant adverse drug reactions (ADRs) such as hematological toxicities, alopecia, neurotoxicity, and cardiotoxicity.

Some natural anticancer products, like Cabazitaxel and Arglabin, showed fewer or no reported adverse events, highlighting the need for comprehensive pharmacovigilance studies to better understand the safety profiles of both natural and synthetic anticancer drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of anticancer drugs derived from natural sources. Tewari, D., Rawat, P., Singh, PK.[2019]

Fucoidan, a polysaccharide derived from brown algae, exhibits a wide range of biological activities, including anti-cancer effects through mechanisms like cell cycle arrest and apoptosis induction, making it a promising candidate for cancer treatment.

Due to its low side effects and ability to enhance the effectiveness of existing chemotherapy drugs, fucoidan is being explored as both a standalone anti-tumor agent and an adjuvant therapy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anti-cancer effects of fucoidan: a review of both in vivo and in vitro investigations. Lin, Y., Qi, X., Liu, H., et al.[2020]

Fucoidan extracted from Okinawa mozuku demonstrated significant anti-tumor effects on 13 out of 15 human cancer cell lines, particularly in hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma, indicating its potential as a treatment for these types of cancers.

The study found that fucoidan increased apoptosis in 5 of the 6 hepatocellular carcinoma cell lines and affected the cell cycle, suggesting that its mechanism of action may involve promoting cell death and disrupting cancer cell proliferation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fucoidan, a major component of brown seaweed, prohibits the growth of human cancer cell lines in vitro. Fukahori, S., Yano, H., Akiba, J., et al.[2013]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Perspectives for the Use of Fucoidans in Clinical Oncology. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Fucoidan and cancer: a multifunctional molecule with anti-tumor potential. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Fucoidan as a marine anticancer agent in preclinical development. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Immunopotentiating Activity of Fucoidans and Relevance to Cancer Immunotherapy. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Fucoidan and Chemotherapeutic Agent Combinations on Malignant and Non-malignant Breast Cell Lines. [2018]

6. India pubmed.ncbi.nlm.nih.gov

Side effects of antineoplastic and immunomodulating medications reported by European consumers. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Application of a patient-centered reverse translational systems-based approach to understand mechanisms of an adverse drug reaction of immune checkpoint inhibitors. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of anticancer drugs derived from natural sources. [2019]

11. England pubmed.ncbi.nlm.nih.gov

The anti-cancer effects of fucoidan: a review of both in vivo and in vitro investigations. [2020]

12. Greece pubmed.ncbi.nlm.nih.gov

Fucoidan, a major component of brown seaweed, prohibits the growth of human cancer cell lines in vitro. [2013]