Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Performance status 0-1, Arm A<br>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<br> <br> Drug: Day 1: Vinorelbine 25 mg/m2<br> <br> Drug: Day 8: Capsule vinorelbine 50 mg/m2<br> <br> Dietary Supplement: Tocotrienol 300 mg x 3 daily until progression<br> <br> |
| Experimental: Performance status 0-1, Arm B<br>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<br> <br> Drug: Day 1: Vinorelbine 25 mg/m2<br> <br> Drug: Day 8: Capsule vinorelbine 50 mg/m2<br> <br> Drug: Placebo 1 capsule x 3 daily until progression<br> <br> |
| Experimental: Performance status 2, Arm A<br>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<br> <br> Drug: Day 1: Vinorelbine 30 mg/m2<br> <br> Drug: Day 8: Capsule vinorelbine 60 mg/m2<br> <br> Dietary Supplement: Tocotrienol 300 mg x 3 daily until progression<br> <br> |
| Experimental: Performance status 2, Arm B<br>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<br> <br> Drug: Day 1: Vinorelbine 30 mg/m2<br> <br> Drug: Day 8: Capsule vinorelbine 60 mg/m2<br> <br> Drug: Placebo 1 capsule x 3 daily until progression<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | From date of randomization until date of first documented progression; assessed up to 36 months |