Tocotrienol as a nutritional supplement in patients with advanced pulmonal cancer

Phase 1

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002742-32-DK
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

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):
- 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 * ULN
- Serum transaminase = 2.5 * ULN
- Serum creatinine = 1.5 ULN
•Written and orally informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to investigate the effect of tocotrienol as a nutritional supplement in combination with first-line chemotherapy on progression free survival (PFS) in patients with advanced NSCLC;Secondary Objective: •To investigate quality of life during treatment<br>•To investigate the potential toxicity of the treatment <br>•To investigaet the response rate<br>•To investigate overall survival;Primary end point(s): Progression free survival ;Timepoint(s) of evaluation of this end point: After two treatment cycles and then every 3 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1Quality of life <br>2Safety and feasibility<br>3Response rate<br>4Overall survival;Timepoint(s) of evaluation of this end point: 1. After 2 treatment cycles and then every 3 months<br>2. Every three weeks during treatment<br>3. After 2 treatment cycles and then every 3 months<br>4. Every 6 months for 30 months