Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.

Prostate Cancer Clinical Trial

Official title:

Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832803
• Other study ID #: 2113
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: January 25, 2019

Study information

• Verified date: February 2019
• Source: Lancashire Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 25, 2019
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prostate cancer receiving radical radiotherapy.

Exclusion Criteria:

• Not nodal disease.

• Not prostate bed radiotherapy.

Related Conditions & MeSH terms

• Prostate Cancer
• Radiotherapy Side Effect

Intervention

Behavioral:
• Empty bladder
No drinking protocol.
• Full bladder
Followed drinking protocol

Locations

Country	Name	City	State
United Kingdom	Lancashire Teaching Hospitals NHS Foundation Trust	Preston

Sponsors (1)

Lead Sponsor	Collaborator
Lancashire Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IPSS score	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.	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.
Secondary	Change in LENT SOMA score	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.	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.
Secondary	Bowel and bladder DVH	Dose to bowel and bladder is calculated and documented if it meets the optimal or mandatory constraints	At time of radiotherapy planning scan which happens at baseline, on day of randomisation.