Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
| Registry | NCT02644252, acronym Toco-Pulm |
|---|---|
| Status | Terminated - The trial was ended prematurely because of a poor accrual rate |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 79 (Actual) |
| Sponsor | Vejle Hospital (Other) |
| Conditions | Lung Cancer |
| Interventions | 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, Tocotrienol 300 mg x 3 daily until progression, Placebo 1 capsule x 3 daily until progression (Drug, dietary supplement) |
| Dates | start 2016-01-01, primary completion 2019-05-09, completion 2021-01-15, first posted 2015-12-31, last updated 2021-05-03 |
| Locations | 1 site in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Lung Cancer All trials of Day 1: Cisplatin 75 mg/m2 All trials of Day 1: Vinorelbine 25 mg/m2
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Performance status 0-1, Arm A | Experimental | Drug: Day 1: Cisplatin 75 mg/m2; Drug: Day 1: Vinorelbine 25 mg/m2; Drug: Day 8: Capsule vinorelbine 50 mg/m2; Dietary Supplement: 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 | Experimental | Drug: Day 1: Cisplatin 75 mg/m2; Drug: Day 1: Vinorelbine 25 mg/m2; Drug: Day 8: Capsule vinorelbine 50 mg/m2; Drug: 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 | Experimental | Drug: Day 1: Carboplatin AUC=5; Drug: Day 1: Vinorelbine 30 mg/m2; Drug: Day 8: Capsule vinorelbine 60 mg/m2; Dietary Supplement: 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 | Experimental | Drug: Day 1: Carboplatin AUC=5; Drug: Day 1: Vinorelbine 30 mg/m2; Drug: Day 8: Capsule vinorelbine 60 mg/m2; Drug: 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 |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Oncology, Vejle Hospital | Vejle | Denmark |