Trial Outcomes & Findings for Sexual Function and Wellbeing in Males With Rectal Cancer (NCT NCT01216202)
NCT ID: NCT01216202
Last Updated: 2023-10-04
Results Overview
Fasting morning venous blood samples were collected at baseline, eg prior to oncological treatment. Men with rectal cancer treated with preoperative radiotherapy (RT) had a second blood sample taken afte RT and before surgery, collected the week before surgery and defined as "after RT/before surgery". Elapsed time between start of RT and the second blood sample was median 38 days, ranging from 3 to 195 days depending on the type of preoperative oncological treatment regimen. Testosterone (T) was analysed at the Department of Clinical Chemistry, Karolinska University Hospital, using commercial assays.
COMPLETED
178 participants
Baseline and after RT/before surgery.
2023-10-04
Participant Flow
Participants with rectal cancer stage I to III planned for rectal resection eligible for the study were enrolled at a tertiary (Karolinska University Hospital) and secondary hospital (Ersta Hospital) in Stockholm during April 2010 and May 2014. Of 372 men with rectal cancer assessed for eligibility, 115 were included in the study.
18 months after start of inclusion, less than 10% of the participants were treated with surgery alone. To increase the sample size of the unexposed group (no preoperative radiotherapy), 63 men with prostate cancer I to III scheduled for robot assisted prostatectomy were included. Participants with prostate cancer were enrolled at the Urology department at Karolinska University Hospital between May 2012 and January 2013.
Participant milestones
| Measure |
Preoperative RT
Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative RT
Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
77
|
|
Overall Study
Analysed at Baseline
|
93
|
75
|
|
Overall Study
Analysed After RT
|
79
|
0
|
|
Overall Study
COMPLETED
|
79
|
75
|
|
Overall Study
NOT COMPLETED
|
22
|
2
|
Reasons for withdrawal
| Measure |
Preoperative RT
Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative RT
Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
0
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
14
|
0
|
Baseline Characteristics
Sexual Function and Wellbeing in Males With Rectal Cancer
Baseline characteristics by cohort
| Measure |
Preoperative RT
n=93 Participants
Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative RT
n=75 Participants
Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
63.3 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
61.6 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
BMI
|
25.3 kg/m^2
STANDARD_DEVIATION 4.1 • n=99 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 3.0 • n=107 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
ASA score
I
|
21 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
ASA score
II
|
51 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
ASA score
III
|
21 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
ASA score
Missing data
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Preoperative RT
Short course RT (5x5 Gy)
|
68 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Preoperative RT
Long course RT (1.8x28 Gy)
|
25 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Preoperative RT
No RT
|
0 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Preoperative chemotherapy
Concomitant chemotherapy
|
23 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Preoperative chemotherapy
Full dose chemotherapy
|
11 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Preoperative chemotherapy
No chemotherapy
|
59 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and after RT/before surgery.Population: For participants in "No preoperative RT", no blood samples were collected at the time point "after RT/before surgery".
Fasting morning venous blood samples were collected at baseline, eg prior to oncological treatment. Men with rectal cancer treated with preoperative radiotherapy (RT) had a second blood sample taken afte RT and before surgery, collected the week before surgery and defined as "after RT/before surgery". Elapsed time between start of RT and the second blood sample was median 38 days, ranging from 3 to 195 days depending on the type of preoperative oncological treatment regimen. Testosterone (T) was analysed at the Department of Clinical Chemistry, Karolinska University Hospital, using commercial assays.
Outcome measures
| Measure |
Preoperative RT
n=93 Participants
Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative RT
n=75 Participants
Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
|
|---|---|---|
|
Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy.
Baseline
|
11.3 nmol/L
Standard Deviation 3.4
|
11.9 nmol/L
Standard Deviation 4.0
|
|
Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy.
After RT/before surgery
|
9.3 nmol/L
Standard Deviation 3.5
|
—
|
PRIMARY outcome
Timeframe: Baseline, 1 and 2 years after surgery.Population: Of the 115 men with rectal cancer included in the study, 21 men left at least one semen sample during the study period and was included in the analysis. 20 of 21 men had RT. In total 40 semen samples was analysed. During follow-up three participants with RT dropped out of the study. Number analysed at each time points represents number of available semen samples at each time point; 19 of 21 at baseline, 9 of 18 1 year after surgery, 12 of 18 2 year after surgery.
Semen samples were collected at the Department of Reproductive Medicine of Karolinska University Hospital after 72h of sexual abstinence and analysed according to World Health Organization 2010 standard. Total number of sperms (million spermatozoa per ejaculate), was calculated by multiplying sperm concentration (million spermatozoa per millilitre semen) with semen volume (milliliter semen/ejaculate). Total number of sperms below 39 million per ejaculate was defined as oligospermia, and 0 million per ejaculate was defined as azoospermia. Semen samples were only collected in men with rectal cancer, not prostate cancer.
Outcome measures
| Measure |
Preoperative RT
n=39 Semen samples
Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative RT
n=1 Semen samples
Men with rectal cancer or prostate cancer treated with surgery alone (no RT).
|
|---|---|---|
|
Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up.
Baseline
|
164.0 million spermatozoa per ejaculate
Interval 5.9 to 1140.0
|
—
|
|
Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up.
1 year after surgery
|
3.15 million spermatozoa per ejaculate
Interval 0.0 to 216.0
|
0.0 million spermatozoa per ejaculate
Interval 0.0 to 0.0
|
|
Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up.
2 years after surgery
|
32.6 million spermatozoa per ejaculate
Interval 0.0 to 187.0
|
—
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
Adverse Events
Preoperative RT
No Preoperative RT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place