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Trial registered on ANZCTR


Registration number
ACTRN12616000728437
Ethics application status
Approved
Date submitted
5/05/2016
Date registered
2/06/2016
Date last updated
3/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Achieving an empty rectum for prostate radiation therapy: comparison of two laxative treatment.
Scientific title
A randomised trial comparing two different types of laxation regimens to reduce rectal volume for patients receiving radiotherapy to the prostate.
Secondary ID [1] 289135 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 298638 0
Condition category
Condition code
Cancer 298702 298702 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised trial comparing the effectiveness of two types of laxation regimens in their ability to achieve an empty rectum during prostate radiation therapy.
Group 1 will be prescribed 1 sachet Movicol Half (Macrogol 3350 6.563g) per day to be consumed orally in the evening. Prescription is as follows
- Use of Movicol half strength is commenced 7 days prior to attending for CT simulation. Once CT simulation is completed use of Movicol half strength is then ceased.
- Use of Movicol Half strength is recommenced 7 days prior to commencing treatment and is then consumed daily for 7 weeks until treatment is completed.

Group 2 will be prescribed Metamucil (9 grams per day) consumed orally as 1 x 3 gram serve added to a 250ml glass of water at breakfast, lunch and dinner. The group will also be prescribed 1 x Nutralife Probiotic 50 supplement consumed orally per day. Prescription is as follows.
- Use of Metamucil is commenced 7 days prior to attending for CT simulation. Once CT simulation is completed use of Metamucil is then ceased.
- Use of Metamucil is recommenced 7 days prior to commencing treatment and is then consumed daily for 7 weeks until treatment is completed.

Compliance will be checked by completion of medication diary for the laxatives and through packet return for the probiotic.
Intervention code [1] 294649 0
Treatment: Other
Intervention code [2] 294679 0
Treatment: Drugs
Comparator / control treatment
The control group will be prescribed 1 sachet Movicol 1/2 strength per day to be consumed orally in the evening. This is commenced 1 week prior to CT planning simulation for radiation treatment, then ceased and recommenced 1 week prior to commencing radiation treatment. Movicol 1/2 strength is then taken daily for duration of treatment (7 weeks) and ceased at the end of treatment.
Control group
Active

Outcomes
Primary outcome [1] 298184 0
Differences in rectal volume between the two treatment arms,
CT scans are routinely conducted during treatment with a total of 12 collected over the treatment period. Rectal volume will be measured by outlining the prostate, bladder and rectum on all CBCT scans. The rectal volume and cross sectional area will be recorded from this data
Timepoint [1] 298184 0
Baseline, daily during the first week of treatment and at weekly intervals over a 7 week period while receiving radiation therapy.
Primary outcome [2] 298224 0
Differences in rectal gas measurements between the two treatment arms,
Rectal gas which will be estimated by viewing the CT scan in the mid-sagittal plane and using a semi quantitative scale of 1-5; representing (1)no gas present, (2) gas occupying 5 to less than 25%, (3) 25 t less than 50%, (4) 50 less than 75% and (5) 75 less than 100% of the rectum.
Timepoint [2] 298224 0
Baseline, daily during the first week of treatment and at weekly intervals over a 7 week period while receiving radiation therapy.
Secondary outcome [1] 323428 0
The number of patients with symptoms of diarrhoea during treatment requiring the cessation of laxatives. This will be assessed at weekly review appointments using the patient self-reported diary which includes the Bristol stool chart.
Timepoint [1] 323428 0
At baseline and weekly over a 7 week period while receiving radiation therapy

Eligibility
Key inclusion criteria
Adult patients fifty years of age or older undergoing external bean radiotherapy (EBRT) to the intact prostate, using fiducial markers for position verification.
Minimum age
50 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Severe constipation, abdominal disease (Crohn’s disease, ulcerative colitis, irritable bowel syndrome), history of extensive abdominal surgery, patients using digoxin or salicylates. Individuals whose primary language is other than English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Patients will be analysed according to the intention to treat principle. Sample size calculation for this study is based on a conservative sample size requiring forty patients in each arm to detect a difference of 4cm3 in the average rectal standard deviation between the two study arms . This sample size calculation, based on their data gives a power of >0.80 to detect a treatment difference between the two groups at the significance level of 0.05. A sample size of up to 60 patients per arm in this study design is being used to account for withdrawals from the study. The total sample size will be up to 120 patients.

Analysis of variance (ANOVA) will be used to determine if a statistically significant difference exists in average rectal volume, across the 12 CT treatment scans, between the two treatment arms. If randomisation is incomplete and groups are unbalanced on any factors (e.g. age), and analysis of covariance (ANCOVA) will be conducted

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5731 0
Orange Health Service - Orange
Recruitment postcode(s) [1] 13207 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 293506 0
Government body
Name [1] 293506 0
Health Education Training Institute
Address [1] 293506 0
Building 12, Gladesville Hospital
Shea Close (off Victoria Road)
Gladesville NSW 2111
Country [1] 293506 0
Australia
Funding source category [2] 293507 0
Hospital
Name [2] 293507 0
Orange Health Service
Address [2] 293507 0
PO Box 319
Orange NSW 2800
Country [2] 293507 0
Australia
Primary sponsor type
Individual
Name
Nicole Weston
Address
PO Box 319
Orange NSW 2800
Country
Australia
Secondary sponsor category [1] 292334 0
Government body
Name [1] 292334 0
Health Education Training Institute
Address [1] 292334 0
Building 12, Gladesville Hospital
Shea Close (off Victoria Road)
Gladesville NSW 2111
Country [1] 292334 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294952 0
Greater Western HREC
Ethics committee address [1] 294952 0
PO Box 143, Level 1, 230 Howick Street, BATHURST NSW 2795
Ethics committee country [1] 294952 0
Australia
Date submitted for ethics approval [1] 294952 0
17/11/2015
Approval date [1] 294952 0
07/02/2016
Ethics approval number [1] 294952 0
HREC/15/GWAHS/120

Summary
Brief summary
The purpose of this study is to investigate whether Metamucil and a probiotic (good bowel bacteria) is more effective than Movicol at emptying the bowel while receiving daily radiation therapy to the prostate.
Who is this for? You may be eligible for this study if you are aged 50 years or more and have been scheduled to undergo external bean radiotherapy (EBRT) to the intact prostate at the Central West Cancer Care Centre at the Orange Health Service.
Study details: Participants will be randomly assigned (by chance) into one of two groups. One group will be prescribed Movicol half strength and a low gas diet (current practice at the treatment facility). The second group will be prescribed Metamucil, Nutralife Probiotic (to promote good bowel bacteria and reduce bowel gas) and a low gas diet.
Standard EBRT treatment for prostate cancer is delivered daily (Monday- Friday) over a 7 week period. Laxatives and probiotic use will commence 1 week prior to attending for the radiation planning appointment, then ceased and recommence one week prior to commencing radiation treatment. You will be required to take the laxatives and probiotic daily during the treatment period. In taking part in this study you will also be required to complete of a food and bowel habits diary and attend weekly review appointment with the Dietitian in addition to your usual review appointments with the Doctor or Nurse.
It is hoped that results from this study will identify the most effective way to ensure an empty bowel while receiving treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65602 0
Mrs Nicole Weston
Address 65602 0
Orange Health Service
c/o Radiation Oncology
PO Box 319
Orange NSW 2800
Country 65602 0
Australia
Phone 65602 0
+61 2 63697360
Fax 65602 0
Email 65602 0
nicole.weston@health.nsw.gov.au
Contact person for public queries
Name 65603 0
Mrs Nicole Weston
Address 65603 0
Orange Health Service
c/o Radiation Oncology
PO Box 319
Orange NSW 2800
Country 65603 0
Australia
Phone 65603 0
+61 2 63697360
Fax 65603 0
Email 65603 0
nicole.weston@health.nsw.gov.au
Contact person for scientific queries
Name 65604 0
Mrs Nicole Weston
Address 65604 0
Orange Health Service
c/o Radiation Oncology
PO Box 319
Orange NSW 2800
Country 65604 0
Australia
Phone 65604 0
+61 2 63697360
Fax 65604 0
Email 65604 0
nicole.weston@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results