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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02644252
Recruitment Status : Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Tracking Information
First Submitted Date  ICMJE December 22, 2015
First Posted Date  ICMJE December 31, 2015
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
Progression free survival [ Time Frame: From date of randomization until date of first documented progression; assessed up to 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer
Official Title  ICMJE Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 28, 2019)
79
Original Estimated Enrollment  ICMJE
 (submitted: December 28, 2015)
190
Estimated Study Completion Date  ICMJE March 2021
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02644252
Other Study ID Numbers  ICMJE Toco-Pulm
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vejle Hospital
Study Sponsor  ICMJE Vejle Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christa H Nyhus, MD Vejle Hospital
PRS Account Vejle Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP