Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized placebo-controlled study with tadalafil

Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized controlled study with tadalafil compared to standard care

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004916-21-SE

Enrollment

160

Registered

2019-01-29

Start date

2019-07-02

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sexual/ erectile function in women and men after treatment for rectal cancer MedDRA version: 20.0 Level: HLGT Classification code 10013356 Term: Sexual function and fertility disorders System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Cialis Product Name: Cialis Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women with rectal cancer stage I-III after clinical and radiologic staging, intention to transabdominal resection of rectal cancer. 2. Patient reported sexual activity before diagnosis or symptoms of rectal cancer according to FSFI-6 and IIEF-5. 3. Age over 18 years 4. Fluent in oral and written Swedish language 5. Females must not be lactating or pregnant at baseline documented by pregnancy test. 6. Given written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: 1. Evidence of systemic disease (metastases) 2. History or evidence of urogenital malignancy 3. History of pelvic radiation 4. Concomitant use of anti-androgens or androgens 5. Contraindications to the use of tadalafil (PDE5-inhibitor) 6. Impaired performance status (Eastern Cooperative Oncology Group (ECOG) performance score above 1. 7. Serious co-existing mental disorder or medical condition e.g. anaemia, liver or renal failure, cardiovascular disease or diabetes. 8. Ongoing drug or alcohol abuse dependence. 9. Has a condition or has received medical treatment that, in the judgement of the investigator, precluded successful participation in the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of prophylactic intake of 5 mg tadalafil on sexual/ erectile function in women and men within a standardized rehabilitation program after treatment for rectal cancer.;Secondary Objective: To evaluate the effect of: 1. prophylaxis of 5 mg tadalafil on severe sexual dysfunction (women) and on severe erectile dysfuntion (men) after treatment of rectal cancer. 2. prophylaxis of 5 mg tadalafil on sexual activity in women after treatment of rectal cancer. 3. prophylaxis of 5 mg tadalafil on attempt to intercourse in women after treatment of rectal cancer 4. prophylaxis of 5 mg tadalafil on sexual activity in men after treatment of rectal cancer. 5. number of patients with use of PDE5-inhibitors at own cost between 6 and 24 months after surgery. 6. prophylaxis of 5 mg tadalafil on genital fibrosis after treatment of rectal cancer. 7. prophylaxis of 5 mg tadalafil on androgen levels after treatment of rectal cancer. 8. prophylaxis of 5 mg tadalafil on bowel function after treatment of rectal cancer. 9. prophylaxis of 5 mg tadalafil on urinary function after treatment of rectal cancer. 10. the safety and tolerability of 5 mg tadalafil during treatment of rectal cancer.;Primary end point(s): Women: Change between baseline and 24 months in sexual function assessed with the total score of the Female Sexual Function Index (FSFI-6). Men: Change between baseline and 24 months in erectile function assessed with the total score of the short version of the International Index of Erectile Function (IIEF-5).;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To evaluate the effect of prophylactic intake of 5 mg tadalafil on sexual/ erectile function in women and men within a standardized rehabilitation program after treatment for rectal cancer.;Secondary Objective: To evaluate the effect of: 1. prophylaxis of 5 mg tadalafil on severe sexual dysfunction (women) and on severe erectile dysfuntion (men) after treatment of rectal cancer. 2. prophylaxis of 5 mg tadalafil on sexual activity in women after treatment of rectal cancer. 3. prophylaxis of 5 mg tadalafil on attempt to intercourse in women after treatment of rectal cancer 4. prophylaxis of 5 mg tadalafil on sexual activity in men after treatment of rectal cancer. 5. number of patients with use of PDE5-inhibitors at own cost between 6 and 24 months after surgery. 6. prophylaxis of 5 mg tadalafil on genital fibrosis after treatment of rectal cancer. 7. prophylaxis of 5 mg tadalafil on androgen levels after treatment of rectal cancer. 8. prophylaxis of 5 mg tadalafil on bowel function after treatment of rectal cancer. 9. prophylaxis of 5 mg tadalafil on urinary function after treatment of rectal cancer. 10. the safety and tolerability of 5 mg tadalafil during treatment of rectal cancer.;Primary end point(s): Women: Change between baseline and 24 months in sexual function assessed with the total score of the Female Sexual Function Index (FSFI-6). Men: Change between baseline and 24 months in erectile function assessed with the total score of the short version of the International Index of Erectile Function (IIEF-5).;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline to 24 months on the proportion of women with severe sexual dysfunction defined as a FSFI-6 score below 20 at baseline and the proportion of men with severe erectile dysfunction defined as IIEF-5 score of 5-7 at baseline. 2. Change from baseline to 24 months on the proportion of sexually active women defined as score 0 on question 2, 3 or 4 in the FSFI-6 questionnaire at baseline. 3. Change from baseline to 24 months on the proportion of women who attempt intercourse defined as score 0 on question 6 in the FSFI-6 questionnaire at baseline. 4. Change from baseline to 24 months on the proportion of sexually active men defined as score “X” (no sexual activity) on question 2, 3, 4 or 5 in the IIEF-5 questionnaire at baseline. 5. Proportion of patients with use of PDE5-inhibitors at least once per month between 6-24 months after surgery for rectal cancer (PDE5-inhibitors users). 6. Fibrosis: 6.1. Women: Change from baseline to 24 months in size of pain-free introducible vaginal dilator (4 categories). 6.2. Men: Change from baseline to 24 months in penile length in flaccid state 7. Change from baseline to 24 months in total and free testosterone, LH, albumin and sex hormone binding globuline (SHBG). 8. Change from baseline to 24 months in Low Anterior Resection Syndrome Score (LARS) or the Colostomy Impact Score (CI) respectively. 9. Change from baseline to 24 months in urinary function (questionnaire) – descriptive statistics. 10. Adverse events from baseline to 6 months after surgery for rectal cancer.;Timepoint(s) of evaluation of this end point: 6, 12, 18, 24 months.	—

Measure

Time frame

Secondary end point(s): 1. Change from baseline to 24 months on the proportion of women with severe sexual dysfunction defined as a FSFI-6 score below 20 at baseline and the proportion of men with severe erectile dysfunction defined as IIEF-5 score of 5-7 at baseline. 2. Change from baseline to 24 months on the proportion of sexually active women defined as score 0 on question 2, 3 or 4 in the FSFI-6 questionnaire at baseline. 3. Change from baseline to 24 months on the proportion of women who attempt intercourse defined as score 0 on question 6 in the FSFI-6 questionnaire at baseline. 4. Change from baseline to 24 months on the proportion of sexually active men defined as score “X” (no sexual activity) on question 2, 3, 4 or 5 in the IIEF-5 questionnaire at baseline. 5. Proportion of patients with use of PDE5-inhibitors at least once per month between 6-24 months after surgery for rectal cancer (PDE5-inhibitors users). 6. Fibrosis: 6.1. Women: Change from baseline to 24 months in size of pain-free introducible vaginal dilator (4 categories). 6.2. Men: Change from baseline to 24 months in penile length in flaccid state 7. Change from baseline to 24 months in total and free testosterone, LH, albumin and sex hormone binding globuline (SHBG). 8. Change from baseline to 24 months in Low Anterior Resection Syndrome Score (LARS) or the Colostomy Impact Score (CI) respectively. 9. Change from baseline to 24 months in urinary function (questionnaire) – descriptive statistics. 10. Adverse events from baseline to 6 months after surgery for rectal cancer.;Timepoint(s) of evaluation of this end point: 6, 12, 18, 24 months.

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Countries

Sweden

Contacts

Public ContactChristian Buchli

Karolinska Institute

christian.buchli@sll.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026