RecruitingPhase 2NCT04597476

A Randomized, Double-blind Study to Evaluate the Clinical Effect and Safety of Fucoidan in Patients With Squamous Cell Carcinomas of the Head and Neck

Sponsor

Hi-Q Marine Biotech International, Ltd.

Enrollment

119 participants

Start Date

Oct 7, 2020

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinomas of the Head and Neck

Summary

This phase II study is a randomized, double-blind study that seeks to evaluate the clinical effects and safety of fucoidan in the treatment of cancer patients with stage III/IV head and neck squamous cell carcinoma. Patients will be centrally randomized in a 1:1 ratio to receive either Fucoidan or placebo (potato starch) Eligible subjects will receive fucoidan twice daily (BID) in combination with chemotherapy and radiation therapy over a 24-week treatment period. Clinical effects and safety parameters for all subjects who complete the treatment period will be followed for an additional 72 weeks after the treatment period.

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fucoidan — a natural compound found in brown seaweed — can improve outcomes when added to standard chemoradiation treatment for people with Stage III or IV head and neck squamous cell carcinoma (cancer of the mouth, throat, or voice box area) that has not yet been treated. **You may be eligible if...** - You have Stage III or IV squamous cell carcinoma of the head and neck with no distant spread - You have not received any prior treatment for this cancer - You are between 20 and 75 years old - Your overall health/functional status is good (ECOG 0–1) - Your kidney, liver, and blood counts meet required levels - Your expected survival is over 6 months **You may NOT be eligible if...** - You have already received any treatment for your head and neck cancer - You have distant metastases - Your organ function is inadequate - Your overall health is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTFucoidan

Fucoidan refers to a class of fucose-enriched sulfated polysaccharides with an average molecular weight of 20,000 Daltons (Da), which can be found in many varieties of edible brown seaweeds and algae . In cell culture studies and animal studies, fucoidan has been shown to possess a range of biological activities, including anti-cancer, anti-inflammatory, and immunoregulatory effects . A recent in vitro study conducted in head and neck squamous cell carcinoma (HNSCC) cell lines (H103, FaDu, and KB) showed that fucoidan could induce cell cycle arrest and possibly apoptosis in a dose-dependent manner, while also enhancing response to cisplatin treatment . In addition, fucoidan has also been shown to inhibit the proliferation of nasopharyngeal carcinoma cells and MC3 human mucoepidermoid carcinoma (MEC) cells .

OTHERPlacebo( Potato starch)

Potato starch 4.4gram

Locations(1)

National Taiwan University Hospital

Taipei County, Taiwan

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NCT04597476