Trial Review

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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
25/07/2019
Date data sharing statement initially provided
25/07/2019
Date results provided
25/07/2019
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
Sex
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 were analysed according to the intention to treat principle. A priori effect size calculation was limited by the absence of published studies comparing two different laxatives in their effects on achieving an empty rectum. Previous studies compared use of a laxative to no intervention (Oates, 2013; Lips, 2012; Smitsman 2008). Sample size for this study was calculated setting power at 80%, alpha (p-value) at 0.05, with a primary outcome of rectal gas ratings (1-5 ordinal scale), using a Mann-Whitney U z test to detect significant difference between two arms, with a minimum 12 scans per patient. Ten patients per arm (i.e. 120 scans per arm), would be sufficient to detect an effect size of 0.38 (small to medium effect size). However, 34 patients in each arm would provide 408 scans per arm, which would be close to the required sample size required for a small effect size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2016
Actual
6/06/2016
Date of last participant enrolment
Anticipated
5/12/2016
Actual
16/12/2016
Date of last data collection
Anticipated
Actual
24/02/2017
Sample size
Target
17
Accrual to date
Final
17
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
Country [1] 293506 0
Australia
Funding source category [2] 293507 0
Hospital
Name [2] 293507 0
Orange Health Service
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
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
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
[email protected]
Contact person for public queries
Name 65603 0
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
[email protected]
Contact person for scientific queries
Name 65604 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing reason. Copy of the final report will be available upon request


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3372Study protocol  [email protected] The study protocol is available upon request by co... [More Details]
3417Clinical study report  [email protected] A copy of the final report can be obtained on requ... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.