Back to results

Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer (Toco-Pulm)

Primary Purpose

Lung Cancer

Status

Terminated

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

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

Day 8: Capsule vinorelbine 60 mg/m2

Tocotrienol 300 mg x 3 daily until progression

Placebo 1 capsule x 3 daily until progression

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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):
- 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.

Exclusion Criteria:

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.

Sites / Locations

Department of Oncology, Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Performance status 0-1, Arm A

Performance status 0-1, Arm B

Performance status 2, Arm A

Performance status 2, Arm B

Arm Description

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.

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.

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

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

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT02644252

First Posted

December 22, 2015

Last Updated

April 28, 2021

Sponsor

Vejle Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02644252

Brief Title

Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

Acronym

Toco-Pulm

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

The trial was ended prematurely because of a poor accrual rate

Study Start Date

January 2016 (Actual)

Primary Completion Date

May 9, 2019 (Actual)

Study Completion Date

January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vejle Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 non-small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Performance status 0-1, Arm A

Arm Type

Experimental

Arm Description

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.

Arm Title

Performance status 0-1, Arm B

Arm Type

Experimental

Arm Description

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.

Arm Title

Performance status 2, Arm A

Arm Type

Experimental

Arm Description

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

Arm Title

Performance status 2, Arm B

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Day 1: Cisplatin 75 mg/m2

Intervention Type

Drug

Intervention Name(s)

Day 1: Vinorelbine 25 mg/m2

Intervention Type

Drug

Intervention Name(s)

Day 8: Capsule vinorelbine 50 mg/m2

Intervention Type

Drug

Intervention Name(s)

Day 1: Carboplatin AUC=5

Intervention Type

Drug

Intervention Name(s)

Day 1: Vinorelbine 30 mg/m2

Intervention Type

Drug

Intervention Name(s)

Day 8: Capsule vinorelbine 60 mg/m2

Intervention Type

Dietary Supplement

Intervention Name(s)

Tocotrienol 300 mg x 3 daily until progression

Intervention Type

Drug

Intervention Name(s)

Placebo 1 capsule x 3 daily until progression

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

From date of randomization until date of first documented progression; assessed up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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): 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christa H Nyhus, MD

Organizational Affiliation

Vejle Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Oncology, Vejle Hospital

City

Vejle

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

We'll reach out to this number within 24 hrs