Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

Lung Cancer Clinical Trial

— Toco-Pulm  

Official title:

Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02644252
• Other study ID #: Toco-Pulm
• Status: Terminated
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: January 15, 2021

Study information

• Verified date: April 2021
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: January 15, 2021
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Day 1: Cisplatin 75 mg/m2

• Day 1: Vinorelbine 25 mg/m2

• Day 8: Capsule vinorelbine 50 mg/m2

• Day 1: Carboplatin AUC=5

• Day 1: Vinorelbine 30 mg/m2

• 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

Locations

Country	Name	City	State
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		From date of randomization until date of first documented progression; assessed up to 36 months