A study of the effect of preoperative chemoradiotherapy on sexual dysfunction in men with locally advanced rectal cancer
Not Applicable
- Conditions
- Rectal CancerMale Sexual DysfunctionCancer - Bowel - Back passage (rectum) or large bowel (colon)Reproductive Health and Childbirth - Other reproductive health and childbirth disorders
- Registration Number
- ACTRN12612000669897
- Lead Sponsor
- Dr Catherine Bettington
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 50
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
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of male sexual dysfunction at 6months post-treatment, as defined by an IIEF (International Index of Erectile Function[At 6 months following radiotherapy]
- Secondary Outcome Measures
Name Time Method 1.the rate of Leydig cell dysfunction at 6 months post-radiotherapy based on evaluation of serum testosterone/FSH and LH levels.[Assessed at 6 months post-radiotherapy];2. the median radiation dose to the testicles during chemoradiotherapy for rectal cancer based on TLD/OSLD measurements and radiotherapy planning software dose calculations.[Assessed during radiotherapy treatment];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)[Assessed at 18 months]