Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

• Status: Terminated
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Carboplatin; Cisplatin; Tocopherols; Tocotrienols; Vinblastine; Vinorelbine; Vitamin E

Criteria

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.