Clinical trial · Interventional
Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer
Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
NCT02644252CI-TRIAL-00051581Toco-PulmterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was ended prematurely because of a poor accrual rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Day 1: Carboplatin AUC=5 | Drug | — | UNRESOLVED |
| Day 1: Cisplatin 75 mg/m2 | Drug | — | UNRESOLVED |
| Day 1: Vinorelbine 25 mg/m2 | Drug | — | UNRESOLVED |
| Day 1: Vinorelbine 30 mg/m2 | Drug | — | UNRESOLVED |
| Day 8: Capsule vinorelbine 50 mg/m2 | Drug | — | UNRESOLVED |
| Day 8: Capsule vinorelbine 60 mg/m2 | Drug | — | UNRESOLVED |
| Placebo 1 capsule x 3 daily until progression | Drug | — | UNRESOLVED |
| Tocotrienol 300 mg x 3 daily until progression | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Performance status 0-1, Arm A
- 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.
- interventionNames
- 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
- type
- EXPERIMENTAL
- label
- Performance status 0-1, Arm B
- 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.
- interventionNames
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.