Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer (Toco-Pulm)
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ClinicalTrials.gov Identifier: NCT02644252 |
Recruitment Status :
Terminated
(The trial was ended prematurely because of a poor accrual rate)
First Posted : December 31, 2015
Last Update Posted : May 3, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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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 Type : | Interventional (Clinical Trial) |
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 : | January 2016 |
Actual Primary Completion Date : | May 9, 2019 |
Actual Study Completion Date : | January 15, 2021 |

Arm | Intervention/treatment |
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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.
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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 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.
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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: 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
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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
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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 |
- Progression free survival [ Time Frame: From date of randomization until date of first documented progression; assessed up to 36 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644252
Denmark | |
Department of Oncology, Vejle Hospital | |
Vejle, Denmark |
Study Chair: | Christa H Nyhus, MD | Vejle Hospital |
Responsible Party: | Vejle Hospital |
ClinicalTrials.gov Identifier: | NCT02644252 |
Other Study ID Numbers: |
Toco-Pulm |
First Posted: | December 31, 2015 Key Record Dates |
Last Update Posted: | May 3, 2021 |
Last Verified: | April 2021 |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Tocotrienols Vitamin E Tocopherols Carboplatin Vinorelbine |
Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antioxidants Protective Agents Physiological Effects of Drugs Vitamins Micronutrients |