Lung cancer Cancer Lung cancer
Conditions
Interventions
Cisplatin-based chemotherapy +/- vitamin supplementation
Sponsors
Royal Marsden Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Male or female, aged over 18 years 3. Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC), SCLC or mesothelioma: locally advanced or metastatic; where giving cisplatin 75 mg/m^2 is appropriate 4. Eastern Cooperative Oncology Group (ECOG): performance status (PS) zero to two 5. Lab requirements at entry: serum creatinine less that or equal to 1.25 Upper Limit of Normal (ULN), creatinine clearance more than 50 ml/min (Ethylene Diamine Tetra-acetic Acid [EDTA]) or more than 60 ml/min (C+G), white blood cell count (WBC) more than 3 x 10^9/l, neutrophils more than 1.5 x 10^9/l, platelets more than 100 x 10^9/l 6. Presence of at least one bi-dimensionally measurable index lesion 7. Effective contraception if indicated 8. Estimated life expectancy of at least 12 weeks 9. Patients are required to stop all complimentary medicines and prior vitamin supplements
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Active infection 3. Inability or unwillingness to take vitamin supplementation 4. Serious systemic disorders incompatible with the study at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of neutropenia 2. Incidence of mucositis 3. Incidence of emesis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria 2. Response rate 3. Overall survival | — |
Countries
United Kingdom
Outcome results
None listed