Clinical trial NCT04597476: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Squamous Cell Carcinomas of the Head and Neck
Lead sponsor: Hi-Q Marine Biotech International, Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 119
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fucoidan Group: Fucoidan 4.4 g, PO, bid for 24 weeks Placebo Group: Potato starch 4.4 g, PO, bid for 24 weeks
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate disease-free survival (DFS) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy
timeFrame: From date of randomization and assessed up to 96 weeks
Secondary outcomes:
measure: To evaluate pain in patients treated with a combination of fucoidan, chemotherapy, and radiation therapy
timeFrame: From date of randomization to the end of treatment period, up to 24 weeks
measure: To evaluate the disease control rate (DCR) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy
timeFrame: From date of randomization and assessed up to 96 weeks
Other outcomes:
measure: To evaluate the safety of fucoidan, as defined by the incidence of treatment-emergent adverse events (TEAEs)
timeFrame: From date of randomization to the end of treatment period, up to 24 weeks
measure: To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: EQ5D
timeFrame: From date of randomization to the end of treatment period, up to 24 weeks
measure: 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
timeFrame: From date of randomization to the end of treatment period, up to 24 weeks
Locations:
city: Taipei county
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Jen Lou
role: PRINCIPAL_INVESTIGATOR
References: