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Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

NCT02644252 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2021-05-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Christa H Nyhus, MD · Vejle Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-05-09
Completion
2021-01-15

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644252 on ClinicalTrials.gov