Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized placebo-controlled study with tadalafil
Key facts
- Where
- Gothenburg, Malmo és Solna, SvédországSee the 3 sites
- Phase
- 2. fázis
Where in Svédország
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGothenburg, SvédországToborzás még nem indult
- Region Skane Skanes UniversitetssjukhusMalmo, SvédországToborzás még nem indult
- Karolinska University HospitalSolna, SvédországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska Institutet
- Trial code
- EU 2023-504592-24-00
- Record updated
- 2024. szeptember 27.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Men and women with rectal cancer stage I-III after clinical and radiologic staging, intention to transabdominal resection of rectal cancer; Patient reported sexual activity before diagnosis or symptoms of rectal cancer according to FSFI-6 and IIEF-5; Age over 18 years; Fluent in oral and written Swedish language; Females must not be lactating or pregnant at baseline documented by pregnancy test; Given written informed consent.
Exclusion: Concomitant use of anti-androgens or androgens; Contraindications to the use of tadalafil (PDE5-inhibitor); Ongoing drug or alcohol abuse dependence; Has a condition or has received medical treatment that, in the judgement of the investigator, precluded successful participation in the study; Evidence of systemic disease (metastases); History or evidence of urogenital malignancy; History of pelvic radiation; Serious co-existing mental disorder or medical condition e.g. anaemia, liver or renal failure, cardiovascular disease or diabetes; Impaired performance status (Eastern Cooperative Oncology Group (ECOG) performance score above 1.