Trial Outcomes & Findings for Sexual Function and Wellbeing in Females With Rectal Cancer (NCT NCT01216189)
NCT ID: NCT01216189
Last Updated: 2021-04-09
Results Overview
Fasting venous blood samples were collected at baseline visit (prior to oncological treatment) and 1 year follow-up. Participants treated with preoperative radiotherapy (RT) had an additional blood sample taken the day before surgery. Serum testosterone levels (T) were measured with liquid chromatography-mass spectrometry using the LC-MS/MS Quattro Premier Xevo TQ MS (Waters Corporation, Milford, MA, USA). The total coefficients of variation (CVtot) were 7% at 2.8 nmol/L and 6% at 15 nmol/L.
COMPLETED
142 participants
Baseline, the week before surgery and 1 year after surgery.
2021-04-09
Participant Flow
Participants were recruited from five Swedish outpatient rectal cancer centres in Sweden (Karolinska University Hospital, Ersta Hospital, Örebro University Hospital, Linköping University Hospital and Norrköping Hospital) between June 2008 and August 2013. Of 404 women with rectal cancer assessed for eligibility, 142 were included in the study.
Participant milestones
| Measure |
Preoperative Radiotherapy
Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative Radiotherapy
Women with rectal cancer treated with surgery alone (no RT).
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
32
|
|
Overall Study
COMPLETED
|
85
|
27
|
|
Overall Study
NOT COMPLETED
|
25
|
5
|
Reasons for withdrawal
| Measure |
Preoperative Radiotherapy
Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative Radiotherapy
Women with rectal cancer treated with surgery alone (no RT).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
3
|
|
Overall Study
Death
|
4
|
2
|
Baseline Characteristics
Sexual Function and Wellbeing in Females With Rectal Cancer
Baseline characteristics by cohort
| Measure |
Preoperative Radiotherapy
n=110 Participants
Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative Radiotherapy
n=32 Participants
Women with rectal cancer treated with surgery alone (no RT).
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
69 years
n=107 Participants
|
65.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
BMI
|
24.2 kg/m2
n=99 Participants
|
24.4 kg/m2
n=107 Participants
|
24.3 kg/m2
n=206 Participants
|
|
ASA score
I
|
35 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
ASA score
II
|
58 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
ASA score
III
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
ASA score
Missing
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Tumour distance from anal verge
0-4 cm
|
45 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Tumour distance from anal verge
5-10 cm
|
40 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Tumour distance from anal verge
11-15 cm
|
23 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Tumour distance from anal verge
Missing
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Type of preoperative RT
Short course (5Gy x5)
|
73 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Type of preoperative RT
Long course (2 Gy x25 or 1.8 x28)
|
37 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Type of preoperative RT
No RT
|
0 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Type of Surgery
Anterior resection
|
54 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Type of Surgery
Abdominal excision
|
53 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Type of Surgery
No abdominal surgery
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Type of Surgery
Missing
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Resection of gynaecological organs
Hysterectomy
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Resection of gynaecological organs
Unilateral/bilateral oophorectomy
|
16 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Resection of gynaecological organs
Partial vaginal resection
|
9 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Resection of gynaecological organs
No resection
|
71 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Resection of gynaecological organs
Missing
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Pathological tumour stage
0
|
10 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Pathological tumour stage
I
|
24 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Pathological tumour stage
II
|
29 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Pathological tumour stage
III
|
39 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Pathological tumour stage
IV
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Pathological tumour stage
Missing
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Neoadjuvant chemotherapy
Yes
|
35 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Neoadjuvant chemotherapy
No
|
74 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Neoadjuvant chemotherapy
Missing
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Adjuvant chemotherapy
Yes
|
36 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Adjuvant chemotherapy
No
|
73 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Adjuvant chemotherapy
Missing
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, the week before surgery and 1 year after surgery.Population: 17 of the included 142 participants were excluded due to history of oophorectomy, resulting in 125 participants analysed. Participants in the group "No preoperative radiotherapy" had no blood samples taken at the time point "After RT/before surgery".
Fasting venous blood samples were collected at baseline visit (prior to oncological treatment) and 1 year follow-up. Participants treated with preoperative radiotherapy (RT) had an additional blood sample taken the day before surgery. Serum testosterone levels (T) were measured with liquid chromatography-mass spectrometry using the LC-MS/MS Quattro Premier Xevo TQ MS (Waters Corporation, Milford, MA, USA). The total coefficients of variation (CVtot) were 7% at 2.8 nmol/L and 6% at 15 nmol/L.
Outcome measures
| Measure |
Preoperative Radiotherapy
n=98 Participants
Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative Radiotherapy
n=27 Participants
Women with rectal cancer treated with surgery alone (no RT).
|
|---|---|---|
|
Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.
Baseline
|
0.6 nmol/l
Interval 0.1 to 3.6
|
0.6 nmol/l
Interval 0.2 to 4.8
|
|
Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.
After RT/before surgery
|
0.6 nmol/l
Interval 0.2 to 3.8
|
—
|
|
Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.
1 year after surgery
|
0.5 nmol/l
Interval 0.1 to 2.3
|
0.6 nmol/l
Interval 0.2 to 1.3
|
PRIMARY outcome
Timeframe: Baseline, 1 year after surgery and 2 years after surgery.Population: Of the 142 participants included in the study, 3 were excluded due to not answering FSFI questionnaires at any timepoint. Total FSFI scores were only calculated for available questionnaires without missing items.
Sexual function was assessed using the Female Sexual Function Index (FSFI). The FSFI questionnaire is a 19-item multiple-choice, self-assessment tool validated for use in the general population as well as for patients with cancer. It covers six domains of sexual function in women; desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). Items scores between 0 or 1 to 5, with lower scores indicating worse function. A total FSFI score can be calculated when all items are completed. Minimal total score is 4 points and maximal score is 95 points, with lower scores indicating worse function. A total FSFI score of less than 26.55 points was used to define overall sexual dysfunction.
Outcome measures
| Measure |
Preoperative Radiotherapy
n=109 Participants
Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
|
No Preoperative Radiotherapy
n=30 Participants
Women with rectal cancer treated with surgery alone (no RT).
|
|---|---|---|
|
Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.
Baseline
|
18.5 score on a scale
Interval 2.0 to 36.0
|
6.7 score on a scale
Interval 2.0 to 30.7
|
|
Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.
1 year after surgery
|
11.1 score on a scale
Interval 2.0 to 34.5
|
5.8 score on a scale
Interval 2.0 to 33.3
|
|
Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.
2 years after surgery
|
10.8 score on a scale
Interval 2.0 to 34.8
|
6.5 score on a scale
Interval 2.3 to 31.7
|
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