Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
15/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 measures

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

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

http://www.snfoundation.org.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/12/2015: no publications found on PubMed.