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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: 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; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark
    • Department of Oncology, Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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	Dietary supplement: 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
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: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Chair: Christa H Nyhus, MD, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): May 9, 2019
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protective Agents; Antineoplastic Agents, Phytogenic; Micronutrients; Vitamins; Antioxidants; Carboplatin; Vitamin E; Tocopherols; Vinorelbine; Tocotrienols
• Other Study ID Numbers: Toco-Pulm