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

Karolinska Institute0 个研究点目标入组 160 人开始时间: 2019年1月29日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Karolinska Institute