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
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
31/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOvary cancer
InterventionFollowing 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1992
Completion date01/05/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1992
Date of final enrolment01/05/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Smith and Nephew Foundation (UK)
Industry

15 Adam Street
London
WC2N 6LA
United Kingdom

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

Funders

Funder type

Research organisation

North West Thames Research and Development (UK)

No information available

Smith and Nephew Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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