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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

NCT04597476 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-03-05

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinomas of the Head and Neck

Interventions

DIETARY_SUPPLEMENT

Fucoidan

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 .

OTHER

Placebo( Potato starch)

Potato starch 4.4gram

Sponsors & Collaborators

  • Hi-Q Marine Biotech International, Ltd.

    lead INDUSTRY

Principal Investigators

  • Pei-Jen Lou · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2024-12-25
Completion
2025-01-23

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597476 on ClinicalTrials.gov