Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

NCT02644252 | Terminated Phase 3 DMC

• 1 other identifier: Toco-Pulm
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  From date of randomization until date of first documented progression; assessed up to 36 months

Study Arms (4)

Performance status 0-1, Arm A

EXPERIMENTAL

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

Performance status 0-1, Arm B

EXPERIMENTAL

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

Performance status 2, Arm A

EXPERIMENTAL

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

Performance status 2, Arm B

EXPERIMENTAL

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

Interventions

Day 1: Cisplatin 75 mg/m2 DRUG

Performance status 0-1, Arm A; Performance status 0-1, Arm B

Day 1: Vinorelbine 25 mg/m2 DRUG

Performance status 0-1, Arm A; Performance status 0-1, Arm B

Day 8: Capsule vinorelbine 50 mg/m2 DRUG

Performance status 0-1, Arm A; Performance status 0-1, Arm B

Day 1: Carboplatin AUC=5 DRUG

Performance status 2, Arm A; Performance status 2, Arm B

Day 1: Vinorelbine 30 mg/m2 DRUG

Performance status 2, Arm A; Performance status 2, Arm B

Day 8: Capsule vinorelbine 60 mg/m2 DRUG

Performance status 2, Arm A; Performance status 2, Arm B

Tocotrienol 300 mg x 3 daily until progression DIETARY_SUPPLEMENT

Performance status 0-1, Arm A; Performance status 2, Arm A

Placebo 1 capsule x 3 daily until progression DRUG

Performance status 0-1, Arm B; Performance status 2, Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Vinorelbine; Tocotrienols

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Christa H Nyhus, MD

  Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2016
• Primary Completion: May 9, 2019
• Study Completion: January 15, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

DK (1)