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

ISRCTN	ISRCTN53863270
DOI	https://doi.org/10.1186/ISRCTN53863270
Secondary identifying numbers	OV4

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1992
Completion date	01/05/1997

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1992
Date of final enrolment	01/05/1997

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Smith and Nephew Foundation (UK)
Industry

15 Adam Street
London
WC2N 6LA
United Kingdom

Website	http://www.snfoundation.org.uk
"ROR"	https://ror.org/03agge938

Research organisation

North West Thames Research and Development (UK)

No information available

Smith and Nephew Foundation (UK)

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

31/10/2019: No publications found. All search options exhausted.
15/12/2015: no publications found on PubMed.