Open, randomised phase III study assessing the toxicity and efficacy of platinum-based chemotherapy with vitamin supplementation in the treatment of lung cancer

ISRCTN	ISRCTN87343655
DOI	https://doi.org/10.1186/ISRCTN87343655
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mary O'Brien
Scientific

Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Study design	Open randomised phase III trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Open, randomised phase III study assessing the toxicity and efficacy of platinum-based chemotherapy with vitamin supplementation in the treatment of lung cancer
Study acronym	MVPV1
Study objectives	To assess whether the addition of vitamin supplementation to chemotherapy may decrease treatment related toxicity and improve efficacy and outcome
Ethics approval(s)	Approved by the Royal Marsden Hospital, 20/01/2006, ref: 05/Q0801/178
Health condition(s) or problem(s) studied	Lung cancer
Intervention	Cisplatin-based chemotherapy +/- vitamin supplementation
Intervention type	Mixed
Primary outcome measure	1. Incidence of neutropenia 2. Incidence of mucositis 3. Incidence of emesis
Secondary outcome measures	1. Disease response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria 2. Response rate 3. Overall survival
Overall study start date	01/01/2006
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	84
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2008

Royal Marsden Hospital

Sutton
SM2 5PT
United Kingdom

Royal Marsden Hospital (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

Website	http://www.royalmarsden.org
"ROR"	https://ror.org/034vb5t35

Government

Royal Marsden NHS Foundation Trust

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/12/2014		Yes	No