Lung CancerPhase 3Toco-PulmNCT02644252

Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

A Phase 3 study testing Day 1: Cisplatin 75 mg/m2, Day 1: Vinorelbine 25 mg/m2 and Day 8: Capsule vinorelbine 50 mg/m2 in people with Lung Cancer, run by Vejle Hospital at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

There is a need for improving the effect of first-line chemotherapy for lung cancer patients, preferably by using an approach with none or very few side effects. In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement on top of standard chemotherapy for patients with advanced… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Day 1: Cisplatin 75 mg/m2, Day 1: Vinorelbine 25 mg/m2 and Day 8: Capsule vinorelbine 50 mg/m2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 1 siteDenmark
Study dates: Jan 2016to 15 Jan 2021
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed non-small cell lung cancer, including squamous cell carcinomas, adenocarcinomas and non-neuroendocrine large cell carcinomas
Patients with advanced stages of NSCLC who are candidates to first-line platinum-based doublet chemotherapy
Measurable disease by RECIST 1.1
Age ≥ 18 years.
Performance status 0-2.
Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

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White blood cells (WBC) ≥ 3.0 * 10^9/l or neutrophils (ANC) ≥ 1.5 * 10^9/l
Platelet count ≥ 100 * 10^9/l
Hemoglobin ≥ 6 mmol/l
Serum bilirubin < 2.0 * upper level of normal (ULN)
Serum transaminase ≤ 2.5 * ULN
Serum creatinine ≤ 1.5 ULN
Written and orally informed consent.

Who cannot join

Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
Patients who have received prior chemotherapy for NSCLC
Patients with NSCLC who are candidates to neoadjuvant chemotherapy or curative chemoradiotherapy
Underlying disease not adequately treated (diabetes, cardiac disease)
Allergy to the active substance or any of the auxiliary agents
Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of Oncology, Vejle Hospital
Vejle

Other trials in Denmark

About this study

Official title: Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

There is a need for improving the effect of first-line chemotherapy for lung cancer patients, preferably by using an approach with none or very few side effects.

In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement on top of standard chemotherapy for patients with advanced non-small cell lung cancer.

Conditions: Lung Cancer
Being tested: Day 1: Cisplatin 75 mg/m2, Day 1: Vinorelbine 25 mg/m2, Day 8: Capsule vinorelbine 50 mg/m2, Day 1: Carboplatin AUC=5, Day 1: Vinorelbine 30 mg/m2
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Day 1: Cisplatin 75 mg/m2Drug
Day 1: Vinorelbine 25 mg/m2Drug
Day 8: Capsule vinorelbine 50 mg/m2Drug
Day 1: Carboplatin AUC=5Drug
Day 1: Vinorelbine 30 mg/m2Drug
Day 8: Capsule vinorelbine 60 mg/m2Drug
Tocotrienol 300 mg x 3 daily until progressionDietary supplement
Placebo 1 capsule x 3 daily until progressionDrug

Study groups in NCT02644252
Study group	Role	What they receive
Performance status 0-1, Arm A	Experimental	Day 1: Cisplatin 75 mg/m2 plus vinorelbine 25 mg/m2. Day 8: Capsule vinorelbine 50 mg/m2. Tocotrienol 300 mg x 3 daily until progression. Receives: Drug: Day 1: Cisplatin 75 mg/m2; Drug: Day 1: Vinorelbine 25 mg/m2; Drug: Day 8: Capsule vinorelbine 50 mg/m2; Dietary Supplement: Tocotrienol 300 mg x 3 daily until progression
Performance status 0-1, Arm B	Experimental	Day 1: Cisplatin 75 mg/m2 plus vinorelbine 25 mg/m2. Day 8: Capsule vinorelbine 50 mg/m2. Placebo 1 capsule x 3 daily until progression. Receives: Drug: Day 1: Cisplatin 75 mg/m2; Drug: Day 1: Vinorelbine 25 mg/m2; Drug: Day 8: Capsule vinorelbine 50 mg/m2; Drug: Placebo 1 capsule x 3 daily until progression
Performance status 2, Arm A	Experimental	Day 1: Carboplatin area under the curve (AUC)=5 plus vinorelbine 30mg/m2. Day 8: Capsule vinorelbine 60 mg/m2. Tocotrienol 300 mg x 3 daily until progression Receives: Drug: Day 1: Carboplatin AUC=5; Drug: Day 1: Vinorelbine 30 mg/m2; Drug: Day 8: Capsule vinorelbine 60 mg/m2; Dietary Supplement: Tocotrienol 300 mg x 3 daily until progression
Performance status 2, Arm B	Experimental	Day 1: Carboplatin area under the curve (AUC)=5 plus vinorelbine 30mg/m2. Day 8: Capsule vinorelbine 60 mg/m2. Placebo 1 capsule x 3 daily until progression Receives: Drug: Day 1: Carboplatin AUC=5; Drug: Day 1: Vinorelbine 30 mg/m2; Drug: Day 8: Capsule vinorelbine 60 mg/m2; Drug: Placebo 1 capsule x 3 daily until progression

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression free survival
Measured: From date of randomization until date of first documented progression; assessed up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201615 Jan 2021

First posted31 Dec 2015 (estimated)
Study startJan 2016
Primary completion9 May 2019
Study completion15 Jan 2021

Why it stopped: The trial was ended prematurely because of a poor accrual rate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02644252
Sponsor's protocol ID: Toco-Pulm
Acronym: Toco-Pulm
Status last verified: Apr 2021
First submitted: 22 Dec 2015
Last updated: 3 May 2021
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT02644252
Acronym / sponsor ID: Toco-Pulm / Toco-Pulm
Conditions: Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was ended prematurely because of a poor accrual rate
Enrolment: 79 participants (actual)
Lead sponsor: Vejle HospitalUniversity, hospital or other
Study start: Jan 2016 (actual)
Primary completion: 9 May 2019 (actual)
Study completion: 15 Jan 2021 (actual)
First posted: 31 Dec 2015 (estimated)
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.

There is a need for improving the effect of first-line chemotherapy for lung cancer patients, preferably by using an approach with none or very few side effects.

In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement on top of standard chemotherapy for patients with advanced non-small cell lung cancer.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Performance status 0-1, Arm A	Experimental	Drug: Day 1: Cisplatin 75 mg/m2, Drug: Day 1: Vinorelbine 25 mg/m2, Drug: Day 8: Capsule vinorelbine 50 mg/m2, Dietary Supplement: Tocotrienol 300 mg x 3 daily until progressionDay 1: Cisplatin 75 mg/m2 plus vinorelbine 25 mg/m2. Day 8: Capsule vinorelbine 50 mg/m2. Tocotrienol 300 mg x 3 daily until progression.
Performance status 0-1, Arm B	Experimental	Drug: Day 1: Cisplatin 75 mg/m2, Drug: Day 1: Vinorelbine 25 mg/m2, Drug: Day 8: Capsule vinorelbine 50 mg/m2, Drug: Placebo 1 capsule x 3 daily until progressionDay 1: Cisplatin 75 mg/m2 plus vinorelbine 25 mg/m2. Day 8: Capsule vinorelbine 50 mg/m2. Placebo 1 capsule x 3 daily until progression.
Performance status 2, Arm A	Experimental	Drug: Day 1: Carboplatin AUC=5, Drug: Day 1: Vinorelbine 30 mg/m2, Drug: Day 8: Capsule vinorelbine 60 mg/m2, Dietary Supplement: Tocotrienol 300 mg x 3 daily until progressionDay 1: Carboplatin area under the curve (AUC)=5 plus vinorelbine 30mg/m2. Day 8: Capsule vinorelbine 60 mg/m2. Tocotrienol 300 mg x 3 daily until progression
Performance status 2, Arm B	Experimental	Drug: Day 1: Carboplatin AUC=5, Drug: Day 1: Vinorelbine 30 mg/m2, Drug: Day 8: Capsule vinorelbine 60 mg/m2, Drug: Placebo 1 capsule x 3 daily until progressionDay 1: Carboplatin area under the curve (AUC)=5 plus vinorelbine 30mg/m2. Day 8: Capsule vinorelbine 60 mg/m2. Placebo 1 capsule x 3 daily until progression

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Histologically confirmed non-small cell lung cancer, including squamous cell carcinomas, adenocarcinomas and non-neuroendocrine large cell carcinomas
Patients with advanced stages of NSCLC who are candidates to first-line platinum-based doublet chemotherapy
Measurable disease by RECIST 1.1
Age ≥ 18 years.
Performance status 0-2.

Key exclusion criteria (8 listed)

Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
Patients who have received prior chemotherapy for NSCLC
Patients with NSCLC who are candidates to neoadjuvant chemotherapy or curative chemoradiotherapy
Underlying disease not adequately treated (diabetes, cardiac disease)

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
Day 1: Cisplatin 75 mg/m2	Drug	Performance status 0-1, Arm A, Performance status 0-1, Arm B
Day 1: Vinorelbine 25 mg/m2	Drug	Performance status 0-1, Arm A, Performance status 0-1, Arm B
Day 8: Capsule vinorelbine 50 mg/m2	Drug	Performance status 0-1, Arm A, Performance status 0-1, Arm B
Day 1: Carboplatin AUC=5	Drug	Performance status 2, Arm A, Performance status 2, Arm B
Day 1: Vinorelbine 30 mg/m2	Drug	Performance status 2, Arm A, Performance status 2, Arm B
Day 8: Capsule vinorelbine 60 mg/m2	Drug	Performance status 2, Arm A, Performance status 2, Arm B
Tocotrienol 300 mg x 3 daily until progression	Dietary supplement	Performance status 0-1, Arm A, Performance status 2, Arm A
Placebo 1 capsule x 3 daily until progression	Drug	Performance status 0-1, Arm B, Performance status 2, Arm B

Primary outcome

Progression free survival
Time frame: From date of randomization until date of first documented progression; assessed up to 36 months

Results and safety

The study was stopped early (reason given: The trial was ended prematurely because of a poor accrual rate). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.

Related trials for Lung Cancer

RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
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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.

Christa H Nyhus, MD study chair

Vejle Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Day 1: Cisplatin 75 mg/m2, Day 1: Vinorelbine 25 mg/m2 and Day 8: Capsule vinorelbine 50 mg/m2 in people with Lung Cancer, run by Vejle Hospital at 1 site in Denmark.

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 13 inclusion and 8 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: stopped early, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial was ended prematurely because of a poor accrual rate). Results are not available in the source record.

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?

Progression free survival (time frame: From date of randomization until date of first documented progression; assessed up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02644252.

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 3 May 2021.