Prostate Cancer, Radiotherapy Side Effect
Conditions
Brief summary
Radical radiotherapy to the prostate is conventionally treated with a full bladder with the aim of minimising dose to the bladder and small bowel to prevent significant side effects. Tolerance of the bladder filling protocol varies depending on patients' baseline urinary function. It is not uncommon for some men to have accidents during treatment causing understandable distress. This can also extend the treatment time and cause knock on delays in the radiotherapy department. Several United Kingdom (UK) centres report treating with an empty bladder. The investigators carried out a feasibility study comparing treatment with full bladder to empty bladder to ascertain if the investigators can safely change our protocol to that of an empty bladder.
Detailed description
50 patients receiving radical radiotherapy to the prostate were randomised using closed envelope technique 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for International prostate Symptom Score(IPSS), Late Effects Normal Tissue Task Force - Subjective, Objective, Management, Analytic (LENT SOMA) bowel toxicity and quality of life questionnaires. The investigators also looked at bowel and bladder Dose Volume Histogram (DVH) to ensure constraints were met.
Interventions
BEHAVIORALEmpty bladder
No drinking protocol.
BEHAVIORALFull bladder
Followed drinking protocol
Sponsors
Lancashire Teaching Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Investigator masking for randomisation purposes only. Masking not possible for intervention whilst on treatment.
Intervention model description
50 patients receiving radical radiotherapy to the prostate were randomised using 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for IPSS, LENT SOMA bowel toxicity and quality of life questionnaires.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate cancer receiving radical radiotherapy.
Exclusion criteria
* Not nodal disease. * Not prostate bed radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in IPSS score | Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up. | IPSS - The International Prostate Symptom Score is a 7 question scale which assesses urinary toxicity. Each question is scored 0-5 totalling a maximum score of 35. A score of 0-7 correlates to mildly symptomatic; 8-19, moderately symptomatic; 20-35, severely symptomatic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LENT SOMA score | Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up. | LENT SOMA - The Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales. This is a questionnaire that assesses individual bowel symptoms asking initially whether or not they occur and then scoring the frequency, the higher the score, the more frequent the event. Each question has it's own range of score which is explained on the questionnaire. The scores will be compared for individual questions and there will not be any combining of scores between questions. |
| Bowel and bladder DVH | At time of radiotherapy planning scan which happens at baseline, on day of randomisation. | Dose to bowel and bladder is calculated and documented if it meets the optimal or mandatory constraints |
Countries
United Kingdom
Outcome results
None listed