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 |
| Protocol serial number | OV4 |
| Sponsor | Smith and Nephew Foundation (UK) |
| Funders | North West Thames Research and Development (UK), Smith and Nephew Foundation (UK) |
- 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
