Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000527864
Ethics application status
Not yet submitted
Date submitted
7/10/2011
Date registered
18/05/2012
Date last updated
18/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A continence promotion intervention involving a pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract, lower bowel symptoms and erectile dysfunction in men receiving radiation therapy with or without androgen deprivation therapy (ADT): A Pilot Study
Scientific title
Men diagnosed with early stage prostate cancer and prescribed radiation therapy with or without neo-adjuvant androgen deprivation therapy will receive a specifically designed continence promotion intervention including a tailored pelvic floor muscle exercise program aimed at reducing lower urinary tract , lower bowel symptoms and erectile dysfunction
Secondary ID [1] 273180 0
Nil
Universal Trial Number (UTN)
U1111-1125-1530
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Treatment 278930 0
Lower Urinary Tract sequelae to radiation therapy with or without androgen deprivation therapy 278936 0
Lower Bowel Dysfunction as sequelae to radiation therapy with or without androgen deprivation therapy 286422 0
Erectile Dysfunction as sequelae to radiation therapy with or without androgen deprivation therapy 286423 0
Condition category
Condition code
Cancer 279111 279111 0 0
Prostate
Physical Medicine / Rehabilitation 279118 279118 0 0
Physiotherapy
Renal and Urogenital 286685 286685 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A specifically designed continence promotion intervention including a tailored pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract , lower bowel symptoms and erectile dysfunction in men receiving radiation therapy with 6 months no-adjuvant androgen deprivation therapy and men NOT receiving (ADT) prior to beginning radiation therapy. Androgen Deprivation Therapy dose will be standardiesd to Lucrin ( leuprorelin) 22.5 mgs intramuscularly 3 monthly.
The intervention will be delivered one on one with physiotherapist. The protocol will be tailored to men's measured pelvic floor muscle function and adherence to the program will be encouraged using motivational interviewing principles. Men receiving radiation therapy alone will meet with physiotherapist for review at all follow-up points which are : immediately radiation therapy completed ,at 1 and 3 months after radiation therapy . Ongoing contact with the physiotherapist will be undertaken using men's preferred method-text/phone/email. All men in the intervention group will receive a copy of the DVD - pelvic floor exercises for men that was produced by the chief investigator for the Prostate Cancer Foundation of Australia. Men receiving ADT will need to exercise for 6 months prior to their RT . These men will also have adherence encouraged as above.
Exercises will be tailored to baseline so men on ADT will need to visit the physiotherapist fortnightly for reassessment and progression. Exercise will need to be performed 3 times daily but the number of repetition each time exercise is undertaken will be tailored to individually to suit the baseline function of men's measured pelvic floor muscle function. The exercise sets will be the number of contractions that can be repeatedly held for and indivicually specified number of seconds. The eventual aim would be for each man to to be able to do 10 Maximal contractions each held for 10 seconds, three times a day in sitting lying or standing start postions . Men will be offered the use of a personal anal perineometer to provide biofeedback and some resistance to their anal sphincter contractions.
Intervention code [1] 269509 0
Treatment: Other
Intervention code [2] 284601 0
Rehabilitation
Intervention code [3] 284807 0
Behaviour
Comparator / control treatment
Usual Care.
Currently men recieve no care instructions when undergoing radiation therapy for prostate cancer except in relation to having empty bladder and bowels at each radiation therapy session.
Men will be prescribed Lucrin as hormone therapy. Currently all men prescribed Lucrin are offered the opportunity to take part in a subsidised general fitness exercise plan. All participants in teh Lucrin arm will offered access to "The Man Plan".
"The Man Plan" is not the exercise program described as pelvic floor muscle exercises.but a general exercise regimen designed for men receiving ADT to maintain general fitness levels that can be affeted by Androgen Deprivation therapy. "The Man Plan" includes no pelvic floor muscle exercises nor continence promotion advice.
"The Man Plan" is promoted by Abbott Laboratories and is not under jurisdiction of the study Physiotherapists. It is an individually tailored fitness program that includes support, education and exercise options but with no attention paid to continence promotion or pelvic floor muscle function. The program is supervised by local exercise physiologists working within 'The Man Plan Program'and will be tailored to fit with individual men's requirements and wishes.
The parameters of exercise frequency and intensity will be recordede within the study
Control group
Active

Outcomes
Primary outcome [1] 279762 0
Lower urinary tract symptoms : incontinence, urgency, frequency, nocturia etcetera validated instrument
ICSMLUTS SF
Lower bowel symptoms evaluated using validated instrument
ICSMLUTS Bowel
Timepoint [1] 279762 0
Baseline for all men:
Immediately following radiation therapy
3 months following radiation therapy
6 months following radiation therapy

Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy
usually 6 months after beginning androgen deprivation therapy.
Thereafter for all men:
Immediately following radiation therapy
3 months after Radiation therapy
6 months after Radiation therapy
Primary outcome [2] 286874 0
Erectile dysfunction using a validated instrument
IIEFQuality of Life validated instrument MYMOP2
Timepoint [2] 286874 0
Baseline for all men

Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy
usually 6 months after beginning androgen deprivation therapy.
Secondary outcome [1] 294378 0
External Anal sphincter squeeze pressure will be measured using a Peritron manometric pressure device with anal plug.
Dynamic Ultraound imaging of pelvic floor muscle function to ascertain upward movement of bladder base during pelvic floor muscle contraction
Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy
usually 6
Timepoint [1] 294378 0
Baseline
Immediately following radiation therapy
3 months following radiation therapy
6 months following radiation therapy
Secondary outcome [2] 294379 0
Survey to assess Acceptability of Pelvic floor muscle function tests using a specificaly designed survey instrument
Timepoint [2] 294379 0
Baseline
Immediately following radiation therapy
3 months following radiation therapy
6 months following radiation therapy
Secondary outcome [3] 296877 0
Exercise diary to assess continence promotion program adherenceClinical Assessment of Pelvic Floor muscle function
and anal sphincter contraction strength
Timepoint [3] 296877 0
Baseline
Immediately following radiation therapy
3 months following radiation therapy
6 months following radiation therapy

Eligibility
Key inclusion criteria
Early stage prostate cancer
Minimum age
40 Years
Maximum age
90 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Not fluent in English
Neurological conditions
Other bladder conditions
Secondary malignancies
Profoundly Deaf
Legally blind
Abdominal surgery in past 2 years

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)
Treating oncologist will invite men into the study and provide comprehensive information sheet.
Men deciding to enter the study will contact study physiotherapist who provides further information and gains consent, makes appointment for baseline measures at which time consent is reaffirmed.

Central randomisation by phone allocation by contacting the holder of the allocation schedule who is 'off-site'
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomised using the minimisation procedure, stratifying for history of Transurethral Resection of the Prostate (TURP).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Men receiving androgen deprivation therapy will have muscle function and continence status compared with men not receiving this therapy.
The goal of the primary end points measurements within the study is not to determine the efficacy of the intervention. The intent of this pilot study is to determine the variation in endpoint measurements so the size of a randomised controlled study with the power to detect such a difference can be established and proceed when funding permits.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 270003 0
University
Name [1] 270003 0
University of Newcastle Faculty of Health
Country [1] 270003 0
Australia
Funding source category [2] 285030 0
Hospital
Name [2] 285030 0
Calvary Mater Hospital Waratah NSW
Country [2] 285030 0
Australia
Funding source category [3] 285209 0
Commercial sector/Industry
Name [3] 285209 0
Abbott Laboratories
Country [3] 285209 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
2308
NSW
Country
Australia
Secondary sponsor category [1] 283894 0
Hospital
Name [1] 283894 0
Calvary Mater Hospital
Address [1] 283894 0
Edith St
Waratah
NSW 2298
Country [1] 283894 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271964 0
Hunter New England Area Health Service Human Research Ethics committee
Ethics committee address [1] 271964 0
Administration Building
1 Lookout Rd
New Lambton NSW
2305
Ethics committee country [1] 271964 0
Australia
Date submitted for ethics approval [1] 271964 0
30/04/2012
Approval date [1] 271964 0
Ethics approval number [1] 271964 0
Ethics committee name [2] 287037 0
University of Newcastle
Ethics committee address [2] 287037 0
University Drive
Callaghan NSW
2308
Ethics committee country [2] 287037 0
Australia
Date submitted for ethics approval [2] 287037 0
30/04/2012
Approval date [2] 287037 0
Ethics approval number [2] 287037 0

Summary
Brief summary
This pilot study aims to define the variation in endpoint measures in men who are prescribed radiation therapy (RT) with or without androgen deprivation therapy (ADT). This will allow the determination of a sample size sufficiently powered to detect such a difference so that a formal randomised controlled trial might be designed. Who is it for? This study is open to men aged 40-90 years with early stage prostate cancer, without any neurological conditions and absent from any other bladder conditions or secondary malignancies. You will not be eligible to participate if you have had any type of abdominal surgery in the past 2 years. You may also be allowed entry to this study if you are currently receiving radiation therapy with 6 months non-adjuvant androgen deprivation therapy, or NOT receiving (ADT) prior to beginning scheduled radiation therapy. Trial details: In this study, you will be randomised to one of two treatment arms. For Arm 1, if you are currently receiving radiation therapy with 6 months non-adjuvant androgen deprivation therapy (ADT) or NOT receiving ADT prior to beginning scheduled radiation therapy, you will receive a specifically designed continence promotion intervention including a tailored pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract , lower bowel symptoms and erectile dysfunction. This intervention will be tailored to you and delivered one on one by a physiotherapist. All men in Arm 1 of the study will receive a copy of a pelvic floor exercise DVD which they will be encouraged to use. If you are receiving radiation therapy alone WITHOUT androgen deprivation therapy, you will meet with a physiotherapist for review immediately after your radiation therapy, and then at 1 and 3 months after it. If you ARE receiving ADT, you will need to exercise for 6 months prior to your scheduled radiotherapy, and these exercises will be tailored to you. For Arm 2, you will receive the current, usual care with no additional instructions when you undergo your radiation therapy, except in relation to having empty bladder and bowels at each radiation therapy session. All men in the study who are receiving Androgen Deprivation Therapy will be given the option to take part in “The Man Plan", an individually tailored general exercise and fitness regimen, which includes support, education and exercise options but with no attention paid to continence promotion or pelvic floor muscle function. The program will be supervised by local exercise physiologists and delivered in a format that suits you best.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33250 0
Address 33250 0
Country 33250 0
Phone 33250 0
Fax 33250 0
Email 33250 0
Contact person for public queries
Name 16497 0
A/Prof Pauline Chiarelli
Address 16497 0
School of Health Sciences
Hunter Building
University of Newcastle
University Drive
Callaghan
NSW 2308
Country 16497 0
Australia
Phone 16497 0
61 2 49216046
Fax 16497 0
Email 16497 0
pauline.chiarelli@newcastle.edu.au
Contact person for scientific queries
Name 7425 0
Prof James Denham
Address 7425 0
Calvary Mater Hospital
Edith St Waratah
NSW 2298
Country 7425 0
Australia
Phone 7425 0
61 2 49211174
Fax 7425 0
Email 7425 0
Jim.Denham@newcastle.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.