Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OV4
Study information
Scientific title
A randomised study to evaluate the impact of malignant ascites on well-being and the role of breathing exercises in delaying the reaccumulation of recurrent ascites
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ovary cancer
Intervention
Following the first ascitic tap patients are randomised to either:
1. Group A: No initial intervention, on recurrence requiring a second ascitic tap patients are taught breathing exercises and required to wear a form of abdominal binder. Treatment to continue until reaccumulation of ascites.
2. Group B: Patients are taught breathing exercises and required to wear a form of abdominal binder. On recurrence requiring a second ascitic tap patients are given daily diuretic therapy with frusemide and spironolactone until reaccumulation of ascites.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1992
Overall trial end date
01/05/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Recurrent abdominal ascites that are a result of relapsed primary resistant cancer of the ovary
2. The ascites is asymptomatic and requires drainage
3. Patients must not be in sub-acute or complete bowel obstruction
4. Performance status <3
5. Life expectancy of at least 12 weeks
6. No longer receiving chemotherapy
7. Adequate haematological profile and biochemistry
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1992
Recruitment end date
01/05/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Smith and Nephew Foundation (UK)
Sponsor details
15 Adam Street
London
WC2N 6LA
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
North West Thames Research and Development (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Smith and Nephew Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list