Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

Phase 3

Terminated

• Conditions: Lung Cancer
• Interventions: Dietary Supplement: Tocotrienol 300 mg x 3 daily until progression; Drug: Placebo 1 capsule x 3 daily until progression

• Registration Number: NCT02644252
• Lead Sponsor: Vejle Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-31
• Study Start: 2016-01
• Primary Completion: 2019-05-09
• Study Completion: 2021-01-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Performance status 0-1, Arm A	Tocotrienol 300 mg x 3 daily until progression	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.
Performance status 0-1, Arm B	Placebo 1 capsule x 3 daily until progression	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.
Performance status 2, Arm A	Tocotrienol 300 mg x 3 daily until progression	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
Performance status 2, Arm B	Placebo 1 capsule x 3 daily until progression	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 Measures

Name	Time	Method
Progression free survival	From date of randomization until date of first documented progression; assessed up to 36 months

Trial Locations

Locations (1)

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark