Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

Sponsor
Vejle Hospital
Study ID
NCT02644252
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
Apr 2021
Primary completion
May 9, 2019
Completion
Jan 15, 2021

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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
  • 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

Primary Outcome Measure

Progression free survival [ Time Frame: From date of randomization until date of first documented progression; assessed up to 36 months ]

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