Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000669897
Ethics application status
Approved
Date submitted
21/06/2012
Date registered
22/06/2012
Date last updated
22/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of the effect of preoperative chemoradiotherapy on sexual dysfunction in men with locally advanced rectal cancer
Scientific title
A single arm prospective study of the effect of preoperative chemoradiotherapy on sexual dysfunction in men with locally advanced rectal cancer
Secondary ID [1] 280715 0
Nil
Universal Trial Number (UTN)
U1111-1132-0132
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal Cancer 286755 0
Male Sexual Dysfunction 286756 0
Condition category
Condition code
Cancer 287057 287057 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Reproductive Health and Childbirth 287064 287064 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational Study of male sexual dysfunction. Duration of observation 18 months. Assessments will be made at baseline (before radiotherapy) and at 3, 6,9, 12 and 18 months following radiotherapy.
Intervention code [1] 285135 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287392 0
Rate of male sexual dysfunction at 6months post-treatment, as defined by an IIEF (International Index of Erectile Function
Timepoint [1] 287392 0
At 6 months following radiotherapy
Secondary outcome [1] 298049 0
1.the rate of Leydig cell dysfunction at 6 months post-radiotherapy based on evaluation of serum testosterone/FSH and LH levels.
Timepoint [1] 298049 0
Assessed at 6 months post-radiotherapy
Secondary outcome [2] 298050 0
2. the median radiation dose to the testicles during chemoradiotherapy for rectal cancer based on TLD/OSLD measurements and radiotherapy planning software dose calculations.
Timepoint [2] 298050 0
Assessed during radiotherapy treatment
Secondary outcome [3] 298051 0
3. Penile bulb dose-volume constraints. Based on review of the doses received to the penile bulb during radiotherapy (derived from the radiotherapy treatment plan)
Timepoint [3] 298051 0
Assessed at 18 months

Eligibility
Key inclusion criteria
1.Age >18years
2.Male
3.Histologically confirmed rectal adenocarcinoma
4. Stage T3-4N0 or N1 disease
5. Requires pre-operative radiotherapy or chemoradiotherapy followed by TME resection
6. Provide informed consent
7. Able to complete sexual function and quality of life questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior pelvic radiotherapy
2. History of impotence
3. Inflammatory bowel disease
4. Prior pelvic surgery
5. Receiving hormonal treatment for prostate cancer
6. Patients taking testosterone supplements

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285485 0
Self funded/Unfunded
Name [1] 285485 0
Country [1] 285485 0
Primary sponsor type
Individual
Name
Dr Catherine Bettington
Address
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield St
Herston
Queensland 4029
Country
Australia
Secondary sponsor category [1] 284335 0
Individual
Name [1] 284335 0
Dr Michelle Grogan
Address [1] 284335 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield St
Herston
Queensland 4029
Country [1] 284335 0
Australia
Other collaborator category [1] 276874 0
Individual
Name [1] 276874 0
Dr Matthew Burge
Address [1] 276874 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield St
Herston
Queensland 4029
Country [1] 276874 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287510 0
Royal Brisbane and Women's Hospital Human Ethics Review Committee
Ethics committee address [1] 287510 0
Ethics committee country [1] 287510 0
Australia
Date submitted for ethics approval [1] 287510 0
Approval date [1] 287510 0
13/06/2012
Ethics approval number [1] 287510 0
HREC/12/QRBW/129

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34337 0
Address 34337 0
Country 34337 0
Phone 34337 0
Fax 34337 0
Email 34337 0
Contact person for public queries
Name 17584 0
Ms Jacqui Keller
Address 17584 0
Clinical Trials Office
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield St
Herston
Queensland 4029
Country 17584 0
Australia
Phone 17584 0
+61 7 36367925
Fax 17584 0
Email 17584 0
[email protected]
Contact person for scientific queries
Name 8512 0
Dr Catherine Bettington
Address 8512 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield St
Herston
Queensland 4029
Country 8512 0
Australia
Phone 8512 0
+61 7 3636 8111
Fax 8512 0
Email 8512 0
[email protected]

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.