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

• ClinicalTrials.gov Identifier: NCT02644252
• Recruitment Status: Active, not recruiting
• First Posted: December 31, 2015
• Last Update Posted: April 22, 2020
• Sponsor: Vejle Hospital
• Information provided by (Responsible Party): Vejle Hospital

Study Description

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

• 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
• Estimated Study Completion Date: March 2021

Arms and Interventions

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

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

• 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

Locations

Denmark

Department of Oncology, Vejle Hospital

Vejle, Denmark

Sponsors and Collaborators

Vejle Hospital

Investigators

• Study Chair: Christa H Nyhus, MD; Vejle Hospital

More Information

• Responsible Party: Vejle Hospital
• ClinicalTrials.gov Identifier: NCT02644252
• Other Study ID Numbers: Toco-Pulm
• First Posted: December 31, 2015
• Last Update Posted: April 22, 2020
• Last Verified: April 2020

Additional relevant MeSH terms:

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; Nutrients; Growth Substances