To Evaluate the QoL Improvement of Oral Oligo Fucoidan in Subjects Receiving Platinum-based Chemotherapy With NSCLC

NCT03130829 | Withdrawn DMC

• 1 other identifier: HiQ-FUCO-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

Primary Objectives: To evaluate the Quality of Life (QoL) score of adding oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects with Non-Small Cell Lung Cancer (NSCLC). Secondary Objectives: To assess the progression-free survival (PFS) and objective response rate (ORR) of adding oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects with NSCLC.

Conditions

NSCLC Stage IV; NSCLC, Stage III

Keywords

NSCLC; QoL; Fucoidan

Outcome Measures

Primary Outcomes (1)

• Quality of Life (QoL)

  Comparison of the QoL score changes from Study Day -2 to End of Platinum-based Treatment Phase between Oligo Fucoidan and placebo groups in intent to treat set (ITT) via the QoL questionnaire

  Day -2 to complete of Platinum-based Treatment Phase(week18)

Secondary Outcomes (4)

• Quality of Life (QoL)

  tinumDay -2 to C1D8(week1), Cycle 3(week9), and Cycle 5(week15) of Platinum-based Treatment Phase

• Progression-Free Survival (PFS)

  Screening (baseline), Cycle 4(week12), complete of Platinum-based Treatment Phase(week18), EOT(week24), and 3 months post-treatment follow up if required

• Objective Response Rate (ORR)

  Screening (baseline), Cycle 4(week12), complete of Platinum-based Treatment Phase(week18), EOT(week24), and 3 months post-treatment follow up if required

• Change of Cytokines

  Screening (baseline), Cycle 3 (week 9), and complete of Platinum-based Treatment Phase(week18)

Study Arms (2)

Oligo Fucoidan

EXPERIMENTAL

Oligo Fucoidan 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment.

Dietary Supplement: Oligo Fucoidan

Placebo

PLACEBO COMPARATOR

Placebo 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment.

Dietary Supplement: Placebo

Interventions

Oligo Fucoidan DIETARY_SUPPLEMENT

Oral, twice daily

Oligo Fucoidan

Placebo DIETARY_SUPPLEMENT

Oral, twice daily

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects must be ≥ 20 years of age, inclusive, at time of screening.
• Life expectancy \> 12 weeks.
• Subject must have cytologically or histologically confirmed NSCLC. Subjects with mixed histology tumors will be eligible. If cytology is used for diagnosis, the sample must be unequivocally NSCLC.
• Subject has Stage III or IV NSCLC disease at the time of screening.
• Subject is not amenable to surgical resection or radiation with curative intent and have not received chemotherapy for their NSCLC, no matter it is new diagnosis or relapse.
• Subject is planned to receive triweekly platinum-based chemotherapy regimen prior to randomization. (Platinum dose for cisplatin is 51\~80 mg/m2, or carboplatin at AUC 4\~6)
• Subject must have at least 1 measurable tumor lesion, not previously irradiated, as defined by RECIST (version 1.1).
• Subject must have no history of brain metastases or evidence of CNS tumors at screening assessment..
• Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
• Subject must be able to take oral medication.
• Subject must have adequate bone marrow, renal and hepatic function as follows:
• Absolute neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L);
• Platelets ≥ 100,000/mm3 (100 × 109/L);
• Hemoglobin ≥ 9.0 g/dL (5.6 mmol/L);
• Serum creatinine concentration within the normal range (according to the standard value of each hospital);

You may not qualify if:

• Subject has a known hypersensitivity to Fucoidan, platinum compounds and all other drug component of current chemotherapy.
• Subject has peripheral neuropathy ≥ grade 2.
• Subject has a history of seizure within 12 months prior to study entry.
• Subject has received more or equal to third-line biomarker-targeted therapy.
• Subject has received herbal remedies for cancer treatment, non-prescription anti-cancer supplements for cancer treatment, or traditional Chinese medicine with an approved anti-cancer indication within 2 weeks prior to randomization.
• Subject is undergone or planned to receive curative radiation therapy prior to randomization and during study. (The palliative radiation therapy such as for bony lesions is allowed, but irradiate on target lesion will not be allowed.)
• Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
• Uncontrolled nausea/vomiting/diarrhea;
• Active uncontrolled infection;
• Symptomatic congestive heart failure;
• Unstable angina pectoris or cardiac arrhythmia;
• Psychiatric illness/social situation that would limit compliance with study requirements;
• History of gross hemoptysis;
• Any medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities.
• Subject is pregnant or lactating.

Sponsors & Collaborators

• Hi-Q Marine Biotech International, Ltd.: lead

Study Sites (3)

Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

Wan-Fang Hospital

Taipei, 116, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, multicenter study

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 27, 2017
• Study Start: April 26, 2017
• Primary Completion: February 28, 2020
• Study Completion: April 30, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

TW (3)