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

Sponsor

Vejle Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02644252

Collaborator

(none)

Enrollment

Location

Arms

60.5

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Day 1: Cisplatin 75 mg/m2 Drug: Day 1: Vinorelbine 25 mg/m2 Drug: Day 8: Capsule vinorelbine 50 mg/m2 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 Drug: Placebo 1 capsule x 3 daily until progression	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

May 9, 2019

Actual Study Completion Date :

Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Performance status 0-1, Arm A 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.	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
Experimental: Performance status 0-1, Arm B 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.	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
Experimental: Performance status 2, Arm A 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	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
Experimental: Performance status 2, Arm B 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	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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.