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

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ClinicalTrials.gov Identifier: NCT02644252
Recruitment Status : Recruiting
First Posted : December 31, 2015
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 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)
Study Start Date : January 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: From date of randomization until date of first documented progression; assessed up to 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Christa H Nyhus, MD christa.haugaard.nyhus@rsyd.dk

Locations
Denmark
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark
Contact: Christa H Nyhus, MD       christa.haugaard.nyhus@rsyd.dk   
Principal Investigator: Lisbeth Bertelsen, MD         
Sponsors and Collaborators
Vejle Hospital
Investigators
Study Chair: Christa H Nyhus, MD Vejle Hospital
More Information
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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT02644252     History of Changes
Other Study ID Numbers: Toco-Pulm
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin
Carboplatin
Vinblastine
Tocotrienols
Vitamin E
 Tocopherols
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
Growth Substances