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 |
| Study type | Participant 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(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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/10/2019: No publications found. All search options exhausted.
15/12/2015: no publications found on PubMed.
