ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Nil known

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate cancer

Condition category

Condition code

Cancer

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]

Treatment: Other

Intervention code [2]

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]

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]

Baseline, daily during the first week of treatment and at weekly intervals over a 7 week period while receiving radiation therapy.

Primary outcome [2]

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]

Baseline, daily during the first week of treatment and at weekly intervals over a 7 week period while receiving radiation therapy.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Orange Health Service - Orange

Recruitment postcode(s) [1]

2800 - Orange

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Education Training Institute

Address [1]

Building 12, Gladesville Hospital
Shea Close (off Victoria Road)
Gladesville NSW 2111

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Orange Health Service

Address [2]

PO Box 319
Orange NSW 2800

Country [2]

Australia

Primary sponsor type

Individual

Name

Nicole Weston

Address

PO Box 319
Orange NSW 2800

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Health Education Training Institute

Address [1]

Building 12, Gladesville Hospital
Shea Close (off Victoria Road)
Gladesville NSW 2111

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Greater Western HREC

Ethics committee address [1]

PO Box 143, Level 1, 230 Howick Street, BATHURST NSW 2795

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/11/2015

Approval date [1]

07/02/2016

Ethics approval number [1]

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

Mrs Nicole Weston

Address

Orange Health Service
c/o Radiation Oncology
PO Box 319
Orange NSW 2800

Country

Australia

Phone

+61 2 63697360

Fax

nicole.weston@health.nsw.gov.au

Contact person for public queries

Name

Nicole Weston

Address

Orange Health Service
c/o Radiation Oncology
PO Box 319
Orange NSW 2800

Country

Australia

Phone

+61 2 63697360

Fax

nicole.weston@health.nsw.gov.au

Contact person for scientific queries

Name

Nicole Weston

Address

Orange Health Service
c/o Radiation Oncology
PO Box 319
Orange NSW 2800

Country

Australia

Phone

+61 2 63697360

Fax

nicole.weston@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
3372	Study protocol			nicole.weston@health.nsw.gov.au	The study protocol is available upon request by co... [More Details]
3417	Clinical study report			nicole.weston@health.nsw.gov.au	A copy of the final report can be obtained on requ... [More Details]

Results publications and other study-related documents

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