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Study on Improving Sexual Function in Men and Women After Rectal Cancer Treatment Using Tadalafil

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What is this study about?

This clinical trial is focused on helping men and women who have been treated for rectal cancer to recover their sexual function. The study is investigating the use of a medication called tadalafil, which is commonly known by the brand name Cialis. Tadalafil is taken in the form of a 5 mg film-coated tablet. The purpose of the study is to evaluate how taking tadalafil might improve sexual and erectile function as part of a rehabilitation program after rectal cancer treatment.

Participants in the study will be randomly assigned to receive either tadalafil or a placebo. The study will follow participants over a period of time to observe changes in their sexual function. This will include regular assessments to see how their sexual health progresses from the start of the study to 24 months later. The study aims to provide insights into whether tadalafil can be a beneficial part of recovery for those who have undergone treatment for rectal cancer.

Throughout the study, participants will be monitored for any changes in their sexual function, as well as any side effects they might experience. The study will also look at other health factors, such as hormone levels and urinary function, to get a comprehensive understanding of the participants’ recovery. The ultimate goal is to determine if tadalafil can help improve the quality of life for individuals recovering from rectal cancer treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, language proficiency, and previous sexual activity before the diagnosis of rectal cancer.

Written informed consent is required to participate.

2 medication administration

Participants receive CIALIS 5 mg film-coated tablets containing the active substance tadalafil.

The medication is taken orally as part of the study protocol.

3 treatment duration

The study evaluates the effect of the medication over a period of 24 months.

Participants are monitored for changes in sexual or erectile function during this time.

4 assessment of sexual function

For women, changes in sexual function are assessed using the Female Sexual Function Index (FSFI-6).

For men, changes in erectile function are assessed using the International Index of Erectile Function (IIEF-5).

5 secondary assessments

Additional assessments include changes in sexual activity, fibrosis, hormone levels, and urinary function.

Adverse events are monitored up to 6 months after surgery for rectal cancer.

6 completion of study

The study is estimated to conclude by June 30, 2026.

Final assessments are conducted to evaluate the long-term effects of the treatment.

Who Can Join the Study?

  • Men and women who have been diagnosed with rectal cancer at stages I to III, which means the cancer is in its early to middle stages, and are planning to have surgery to remove the cancer through the abdomen.
  • Patients who were sexually active before their rectal cancer diagnosis or had symptoms related to rectal cancer, as measured by specific questionnaires called FSFI-6 and IIEF-5. These are tools used to assess sexual function.
  • Must be over 18 years old.
  • Must be able to speak and write in Swedish fluently.
  • Women must not be breastfeeding or pregnant at the start of the study, confirmed by a pregnancy test.
  • Must have given written consent to participate in the study, meaning they agree to join after being informed about the study details.

Who Cannot Join the Study?

  • Patients who have not been treated for rectal cancer.
  • Individuals who are not experiencing issues with sexual or erectile function after rectal cancer treatment.
  • People who are not part of the specified age range for the study.
  • Individuals who are not willing to participate in a standardized rehabilitation program.
  • Patients who are not eligible to take 5 mg of tadalafil, a medication used to help with sexual function.
  • Individuals who are not able to provide informed consent, meaning they cannot understand and agree to the study’s requirements.
  • People who are part of a vulnerable population, which means they might need extra protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not yet recruiting
07.12.2020

Trial locations

Investigated drugs:

Tadalafil is a medication used in this trial to help improve sexual and erectile function in both men and women who have been treated for rectal cancer. It is being tested as part of a standardized rehabilitation program to see if it can aid in the recovery of sexual function when taken regularly.

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It often starts as small, benign clumps of cells called polyps that can develop into cancer over time. As the disease progresses, it can invade nearby tissues and organs, potentially spreading to other parts of the body. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may advance more aggressively. Early detection and monitoring are crucial for managing the disease effectively.

Sexual Dysfunction in Women – Sexual dysfunction in women refers to persistent problems with sexual response, desire, orgasm, or pain that distress the individual or strain relationships. It can be influenced by physical, hormonal, or psychological factors, and may be exacerbated by treatments for conditions like rectal cancer. The condition can manifest as a lack of sexual interest, difficulty in becoming aroused, or pain during intercourse. Over time, these issues can impact emotional well-being and intimate relationships. The progression of sexual dysfunction can vary, with some women experiencing temporary issues while others may face long-term challenges. Addressing underlying causes and open communication are important for managing this condition.

Erectile Dysfunction in Men – Erectile dysfunction (ED) is the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. It can result from physical conditions such as vascular disease, diabetes, or as a side effect of treatments for rectal cancer. Psychological factors like stress or anxiety can also contribute to ED. The condition can lead to reduced self-esteem and relationship difficulties. The progression of erectile dysfunction can be gradual, with symptoms worsening over time if underlying causes are not addressed. Understanding and addressing the root causes are key to managing erectile dysfunction effectively.

Trial ID:
2023-504592-24-00
Protocol code:
30July2021Version6.0
Trial Phase:
Therapeutic exploratory (Phase II)

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