tadalafil for Rectal cancer | Sexual dysfunction

Inclusion criteria

• {"criterion_text":"- Men and women with rectal cancer stage I-III after clinical and radiologic staging, intention to transabdominal resection of rectal cancer.\n- Patient reported sexual activity before diagnosis or symptoms of rectal cancer according to FSFI-6 and IIEF-5.\n- Age over 18 years\n- Fluent in oral and written Swedish language\n- Females must not be lactating or pregnant at baseline documented by pregnancy test.\n- Given written informed consent"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Women: Change between baseline and 24 months in sexual function assessed with the total score of the Female Sexual Function Index (FSFI- 6).","definition_or_measurement_approach":"Change from baseline to 24 months measured by total score of the FSFI-6 questionnaire (female sexual function)."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Change from baseline to 24 months measured by total score of the IIEF-5 questionnaire (male erectile function)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion change from baseline to 24 months; severe dysfunction defined by FSFI-6 <20 (women) and IIEF-5 5-7 (men)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion change from baseline to 24 months; sexually active women defined by specified FSFI-6 question scores at baseline."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion change from baseline to 24 months; attempt to intercourse defined by FSFI-6 question 6 criteria."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion change from baseline to 24 months; sexually active men defined by specified IIEF-5 question responses at baseline."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Proportion of patients reporting use of PDE5-inhibitors ≥ once per month during months 6–24 post-surgery."}
• {"endpoint_text":"- Fibrosis:Women: Change from baseline to 24 months in size of pain-free introducible vaginal dilator (4 XML File Identifier: pCoXtm4xKBCBEk2OP0cw1CYwmjU= Page 12/23 categories).","definition_or_measurement_approach":"Change from baseline to 24 months in size category of pain-free introducible vaginal dilator (as per protocol category classification)."}
• {"endpoint_text":"- Fibrosis: Men: Change from baseline to 24 months in penile length in flaccid state","definition_or_measurement_approach":"Change from baseline to 24 months in flaccid penile length (measurement method per protocol)."}
• {"endpoint_text":"- Change from baseline to 24 months in total and free testosterone, LH, albumin and sex hormone binding globuline (SHBG).","definition_or_measurement_approach":"Change from baseline to 24 months in specified blood hormone and protein levels (total/free testosterone, LH, albumin, SHBG)."}
• {"endpoint_text":"- Change from baseline to 24 months in Low Anterior Resection Syndrome Score (LARS) or the Colostomy Impact Score (CI) respectively.","definition_or_measurement_approach":"Change from baseline to 24 months in LARS score or Colostomy Impact Score as applicable."}
• {"endpoint_text":"- Change from baseline to 24 months in urinary function (questionnaire) – descriptive statistics.","definition_or_measurement_approach":"Change from baseline to 24 months in urinary function using questionnaire measures; reported descriptively."}
• {"endpoint_text":"- Adverse events from baseline to 6 months after surgery for rectal cancer.","definition_or_measurement_approach":"Safety: collection and reporting of adverse events from baseline through 6 months post-surgery."}

Sweden

Earliest CTIS Part Ii Submission Date

22-09-2024

Latest Decision Or Authorization Date

27-09-2024

Processing Time Days

5

Number Of Sites

3

Number Of Participants

80

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden