NSCLC Stage IVNCT03130829
To Evaluate the QoL Improvement of Oral Oligo Fucoidan in Subjects Receiving Platinum-based Chemotherapy With NSCLC
A study testing Oligo Fucoidan in people with NSCLC Stage IV and NSCLC, Stage III, run by Hi-Q Marine Biotech International, Ltd. at 3 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC Stage IV, NSCLC, Stage III
- What is being tested?
- Oligo Fucoidan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesTaiwan
- Study dates
- 26 Apr 2017to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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);
- Hepatic function: AST and ALT ≤ 2.5 times upper limit of normal unless liver metastases are present, then AST and ALT < 5.0 times upper limit of normal; bilirubin ≤ 1.5 times upper limit of normal (subjects with Gilbert's Syndrome may have a bilirubin ≤ 3.0 times upper limit of normal).
- Female and male patients of childbearing potential and at the risk of pregnancy must agree to use at least one of highly effective contraception method throughout the study.
- Subject must be capable of understanding and complying with parameters as outlined in the protocol and able to sign inform consent.
Who cannot join
- 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.)
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- 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.
- Subject participates in study using an investigational drug within 30 days prior to screening.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Shuang Ho Hospital
New Taipei City, 235
Wan-Fang Hospital
Taipei, 116
Taipei Medical University Hospital
Taipei
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Pilot Study to Evaluate the Quality of Life Improvement of Oral Oligo Fucoidan as an Adjuvant in Subjects Receiving Platinum-based Chemotherapy With NSCLC
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.
Read the detailed description
This is a pilot, randomized, double-blind, multicenter study to evaluate the QoL score of Oligo Fucoidan plus platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in subjects with NSCLC. Subjects will be randomized in a 1:1 ratio to receive 4.4 g BID of Oligo Fucoidan or placebo BID. Subject randomization will be stratified by NSCLC disease stage (stage III and stage IV) and platinum-based drug (cisplatin and carboplatin).
This is a two-part study. The study treatment will be planned as follow:
- Part I (Platinum-based Treatment Phase): Oligo Fucoidan/placebo in combination with 4~6 cycles of platinum-based chemotherapy;
- Part II (Extension Phase): Continuous Oligo Fucoidan/placebo treatment after subject completed platinum-based chemotherapy.
The total study treatment duration of investigational product from Part I to Part II will be 6 months.
Dosing of oral Oligo Fucoidan/placebo will begin on Study Day -2, 2 days prior to the start of the platinum-based chemotherapy regimen, and will continue twice a day (BID) through the following 6-months treatment period, which includes platinum-based treatment phase and extension phase, if there's no treatment interruption. All subjects will receive platinum-based IV infusion starting on Day 1 of each cycle, 3 weeks per cycle. Subjects will continue to receive Oligo Fucoidan/placebo for 6 months until develop of treatment toxicity which in the Investigator's opinion prohibits for further therapy, or until radiographic progression of disease. Subjects who experience toxicities due to chemotherapy may require a delay in the dosing schedule or a dose modification. Should a subject not receive platinum-based chemotherapy on a scheduled cycle, a rescheduled cycle will be designated when chemotherapy is reintroduced, but no more than 2 weeks delay.
The visit for subjects who have completed platinum-based treatment phase will be considered as the End of Part I Visit (end of platinum-based treatment phase). The visit for subjects who have completed 6-months treatment period (Part I \& Part II) will be considered as the End of Treatment (EOT) Visit. It is preferable that EOT Visit procedures will be conducted for subjects prior to the initiation of another anticancer therapy.
Radiographic tumor assessments will be conducted at screening period, Cycle 4, End of Platinum-based Treatment Phase, and EOT. Radiographic information will be collected according to the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Toxicities will be graded at each study visit according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Quality of life assessment as measured by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) as well as health-related quality of life questionnaire designed by the National Health Research Institutes (NHRI), NHRI QLQ-TCM, based on traditional Chinese medicine (TCM) perspective. Both of them will be performed at Study Day -2, Day 8 of Cycle 1, Day 1 of Cycle 3 \& Cycle 5, and End of Platinum-based Treatment Phase.
- Conditions
- NSCLC Stage IV, NSCLC, Stage III
- Being tested
- Oligo Fucoidan, Placebo
- Keywords
- NSCLC, QoL, Fucoidan
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligo FucoidanDietary supplement
Oral, twice daily
PlaceboDietary supplement
Oral, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Oligo Fucoidan | Experimental | Oligo Fucoidan 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment. Receives: Dietary Supplement: Oligo Fucoidan |
| Placebo | Placebo comparator | Placebo 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day -2 to complete of Platinum-based Treatment Phase(week18)
Secondary outcomes (4)
Quality of Life (QoL)
Comparison of the QoL score changes from Study Day -2 to C1D8, C3D1, and C5D1 of Platinum-based Treatment Phase between Oligo Fucoidan and placebo groups in intent to treat set (ITT) via the QoL questionnaire.
Measured: tinumDay -2 to C1D8(week1), Cycle 3(week9), and Cycle 5(week15) of Platinum-based Treatment Phase
Progression-Free Survival (PFS)
Progression-Free Survival will be evaluated according to radiographic progression per RECIST version 1.1 and survival information (death)
Measured: 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)
Objective Response Rate will be evaluated using measurements according to RECIST version 1.1
Measured: 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
To evaluate the changes of cytokine
Measured: Screening (baseline), Cycle 3 (week 9), and complete of Platinum-based Treatment Phase(week18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start26 Apr 2017 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Why it stopped: target population is insufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, multicenter study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hi-Q Marine Biotech International, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130829
- Sponsor's protocol ID
- HiQ-FUCO-002
- Status last verified
- Aug 2019
- First submitted
- 17 Apr 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel, Pilot Study to Evaluate the Quality of Life Improvement of Oral Oligo Fucoidan as an Adjuvant in Subjects Receiving Platinum-based Chemotherapy With NSCLC
- ClinicalTrials.gov ID
- NCT03130829
- Acronym / sponsor ID
- HiQ-FUCO-002
- Conditions
- NSCLC Stage IV, NSCLC, Stage III
- Keywords
- NSCLC, QoL, Fucoidan
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: target population is insufficient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hi-Q Marine Biotech International, Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot, randomized, double-blind, multicenter study to evaluate the QoL score of Oligo Fucoidan plus platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in subjects with NSCLC. Subjects will be randomized in a 1:1 ratio to receive 4.4 g BID of Oligo Fucoidan or placebo BID. Subject randomization will be stratified by NSCLC disease stage (stage III and stage IV) and platinum-based drug (cisplatin and carboplatin).
This is a two-part study. The study treatment will be planned as follow:
- Part I (Platinum-based Treatment Phase): Oligo Fucoidan/placebo in combination with 4~6 cycles of platinum-based chemotherapy;
- Part II (Extension Phase): Continuous Oligo Fucoidan/placebo treatment after subject completed platinum-based chemotherapy.
The total study treatment duration of investigational product from Part I to Part II will be 6 months.
Dosing of oral Oligo Fucoidan/placebo will begin on Study Day -2, 2 days prior to the start of the platinum-based chemotherapy regimen, and will continue twice a day (BID) through the following 6-months treatment period, which includes platinum-based treatment phase and extension phase, if there's no treatment interruption. All subjects will receive platinum-based IV infusion starting on Day 1 of each cycle, 3 weeks per cycle. Subjects will continue to receive Oligo Fucoidan/placebo for 6 months until develop of treatment toxicity which in the Investigator's opinion prohibits for further therapy, or until radiographic progression of disease. Subjects who experience toxicities due to chemotherapy may require a delay in the dosing schedule or a dose modification. Should a subject not receive platinum-based chemotherapy on a scheduled cycle, a rescheduled cycle will be designated when chemotherapy is reintroduced, but no more than 2 weeks delay.
The visit for subjects who have completed platinum-based treatment phase will be considered as the End of Part I Visit (end of platinum-based treatment phase). The visit for subjects who have completed 6-months treatment period (Part I \& Part II) will be considered as the End of Treatment (EOT) Visit. It is preferable that EOT Visit procedures will be conducted for subjects prior to the initiation of another anticancer therapy.
Radiographic tumor assessments will be conducted at screening period, Cycle 4, End of Platinum-based Treatment Phase, and EOT. Radiographic information will be collected according to the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Toxicities will be graded at each study visit according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Quality of life assessment as measured by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) as well as health-related quality of life questionnaire designed by the National Health Research Institutes (NHRI), NHRI QLQ-TCM, based on traditional Chinese medicine (TCM) perspective. Both of them will be performed at Study Day -2, Day 8 of Cycle 1, Day 1 of Cycle 3 \& Cycle 5, and End of Platinum-based Treatment Phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Oligo Fucoidan | Experimental | Dietary Supplement: Oligo FucoidanOligo Fucoidan 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oligo FucoidanOral, twice daily | Dietary supplement | Oligo Fucoidan |
| PlaceboOral, twice daily | Dietary supplement | Placebo |
Primary outcome
Quality of Life (QoL)
Time frame: Day -2 to complete of Platinum-based Treatment Phase(week18)
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
4 secondary outcomes
Quality of Life (QoL)
Time frame: tinumDay -2 to C1D8(week1), Cycle 3(week9), and Cycle 5(week15) of Platinum-based Treatment Phase
Progression-Free Survival (PFS)
Time frame: 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)
Time frame: 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
Time frame: Screening (baseline), Cycle 3 (week 9), and complete of Platinum-based Treatment Phase(week18)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligo Fucoidan in people with NSCLC Stage IV and NSCLC, Stage III, run by Hi-Q Marine Biotech International, Ltd. at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: Day -2 to complete of Platinum-based Treatment Phase(week18)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.