Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer (Toco-Pulm)

Vejle Hospital

Status and phase: Terminated; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Day 1: Vinorelbine 25 mg/m2; Drug: Day 1: Cisplatin 75 mg/m2; Drug: Day 8: Capsule vinorelbine 60 mg/m2; Dietary Supplement: Tocotrienol 300 mg x 3 daily until progression; Drug: Day 8: Capsule vinorelbine 50 mg/m2; Drug: Day 1: Vinorelbine 30 mg/m2; Drug: Placebo 1 capsule x 3 daily until progression; Drug: Day 1: Carboplatin AUC=5

Study type: Interventional

Funder types: Other

Identifiers

NCT02644252

Toco-Pulm

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 4 patient groups

Performance status 0-1, Arm A

Experimental group

Description:

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.

Treatment:

Drug: Day 1: Cisplatin 75 mg/m2

Drug: Day 1: Vinorelbine 25 mg/m2

Dietary Supplement: Tocotrienol 300 mg x 3 daily until progression

Drug: Day 8: Capsule vinorelbine 50 mg/m2

Performance status 0-1, Arm B

Experimental group

Description:

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.

Treatment:

Drug: Day 1: Cisplatin 75 mg/m2

Drug: Day 1: Vinorelbine 25 mg/m2

Drug: Placebo 1 capsule x 3 daily until progression

Drug: Day 8: Capsule vinorelbine 50 mg/m2

Performance status 2, Arm A

Experimental group

Description:

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

Treatment:

Drug: Day 1: Carboplatin AUC=5

Dietary Supplement: Tocotrienol 300 mg x 3 daily until progression

Drug: Day 8: Capsule vinorelbine 60 mg/m2

Drug: Day 1: Vinorelbine 30 mg/m2

Performance status 2, Arm B

Experimental group

Description:

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

Treatment:

Drug: Day 1: Carboplatin AUC=5

Drug: Placebo 1 capsule x 3 daily until progression

Drug: Day 8: Capsule vinorelbine 60 mg/m2

Drug: Day 1: Vinorelbine 30 mg/m2