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

March 3, 2024 updated by: Hi-Q Marine Biotech International, Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

The total length of the study for each subject will be approximately 100 weeks, comprising the following time periods: screening period (28 days), treatment period (24 weeks), and follow-up period (72 weeks).

Study Type

Interventional

Enrollment (Estimated)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei county, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patients with stage III/IV head and neck squamous cell carcinoma (HNSCC) withoutdistant metastasis who had not received any treatment to head and neck cancer can be enrolled in this study.
  2. Completed a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the head and neck (including the primary tumor and neck nodes) within 6 weeks prior to enrollment.
  3. Adequate renal function, with serum creatinine ≤ 1.5 mg/dL. Patients with serum creatinine > 1.5 mg/dL may be eligible if calculated creatinine clearance ≥ 55 mL/min as based on the results of the Cockcroft-Gault Equation or 24-hour urine collection.
  4. Age ≥ 20 years and ≤ 75 years.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.
  6. Expected lifespan > 6 months.
  7. Adequate bone marrow function, as defined by absolute neutrophil count ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.
  8. Adequate hepatic function, with total bilirubin ≤ 1.5 × upper normal limit (UNL; patients with hyperbilirubinemia caused by Gilbert's syndrome may be eligible if total bilirubin ≤ 2.5 × UNL), aspartate aminotransferase (AST) ≤ 2.5 × UNL, alanine aminotransferase (ALT) ≤ 2.5 × UNL, and alkaline phosphatase (ALP) ≤ 2.5 × UNL.
  9. Men and women of childbearing potential must consent to the use of effective contraception while on treatment period.
  10. Patients must be able to understand and be willing to sign a written informed consent document.
  11. Patients must be able to comply with the study protocol.

Exclusion Criteria:

  1. Diagnosed as nasopharyngeal cancer.
  2. Body mass index (BMI) < 18.5.
  3. Significant history of cardiac disease (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias, etc.).
  4. Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.
  5. Previously received chemotherapy, radiation therapy, or immunotherapy for head and neck cancer.
  6. Dysphagia patients who do not consent to nasogastric (NG), orogastric (OG), or percutaneous endoscopic gastrostomy (PEG) feeding.
  7. History or clinical evidence of any hyperthyroidism, cirrhosis, hepatic failure, human immunodeficiency virus (HIV) infection, renal failure (as determined by a serum creatinine > 250 µmol/L or > 2.83 mg/dL at screening), active tuberculosis (as confirmed by sputum or other microbiological methods within the last five years), or active hepatitis B/C.
  8. Any other clinical disorders or unsuitable conditions that render the patient ineligible for this study, as determined by the principal investigator(s).
  9. Treatment with any investigational product or health supplement within 28 days prior to enrollment.
  10. Pregnant or breastfeeding women.
  11. Non-compliance with the requirement for contraception or other aspects of the study protocol.
  12. Inability to understand and provide informed consent regarding participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fucoidan Group
Fucoidan powder at 4.4 g per sachet (dose) for oral administration. Fucoidan 4.4 g, PO, bid for 24 weeks
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 .
Placebo Comparator: Potato starch
Potato starch at 4.4 g per sachet (dose) for oral administration. Potato starch 4.4 g, PO, bid for 24 weeks
Other: Placebo( Potato starch)
Potato starch 4.4gram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate disease-free survival (DFS) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy
Time Frame: From date of randomization and assessed up to 96 weeks
To evaluate disease-free survival (DFS) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy
From date of randomization and assessed up to 96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate pain in patients treated with a combination of fucoidan, chemotherapy, and radiation therapy
Time Frame: From date of randomization to the end of treatment period, up to 24 weeks
To evaluate pain in patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by a numerical rating scale (NRS: 0-10)
From date of randomization to the end of treatment period, up to 24 weeks
To evaluate the disease control rate (DCR) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy
Time Frame: From date of randomization and assessed up to 96 weeks
To evaluate the disease control rate (DCR) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy
From date of randomization and assessed up to 96 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of fucoidan, as defined by the incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From date of randomization to the end of treatment period, up to 24 weeks
To evaluate the safety of fucoidan, as defined by the incidence of treatment-emergent adverse events (TEAEs)
From date of randomization to the end of treatment period, up to 24 weeks
To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: EQ5D
Time Frame: From date of randomization to the end of treatment period, up to 24 weeks
To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: EuroQol five dimensions questionnaire (EQ5D)
From date of randomization to the end of treatment period, up to 24 weeks
To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: EORTC QLQ-H&N35
Time Frame: From date of randomization to the end of treatment period, up to 24 weeks
To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 35 (H&N 35)
From date of randomization to the end of treatment period, up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hi-Q Marine Biotech International, Ltd.

Investigators

  • Principal Investigator: Pei-Jen Lou, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

January 23, 2025

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIQ-FUCO-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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