Lung Cancer
Conditions
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.
Interventions
DRUGDay 1: Carboplatin AUC=5
DRUGDay 1: Vinorelbine 30 mg/m2
DRUGDay 8: Capsule vinorelbine 60 mg/m2
DRUGDay 1: Cisplatin 75 mg/m2
DRUGDay 1: Vinorelbine 25 mg/m2
DRUGDay 8: Capsule vinorelbine 50 mg/m2
DIETARY_SUPPLEMENTTocotrienol 300 mg x 3 daily until progression
DRUGPlacebo 1 capsule x 3 daily until progression
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | From date of randomization until date of first documented progression; assessed up to 36 months |
Countries
Denmark
Outcome results
None listed