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Study on Improving Sexual Health and Quality of Life in Cervical Cancer Patients Using Estriol, Estradiol Hemihydrate, and Promestriene

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on improving the sexual health and quality of life for patients who have been treated for cervical cancer. The study will explore the effects of a multimodal intervention, which includes various treatments and lifestyle changes, compared to standard care. The main goal is to see if these interventions can enhance sexual function and overall well-being as reported by the patients themselves.

The trial will involve several treatments, including estriol, estradiol hemihydrate, promestriene, progesterone, and estradiol valerate. Estriol is administered as a vaginal treatment, while estradiol hemihydrate is given through a transdermal patch, which means it is absorbed through the skin. Promestriene is used as a vaginal cream, progesterone is taken orally in the form of soft capsules, and estradiol valerate is provided as coated tablets for oral use. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

Participants in the study will be monitored over a period of time to assess changes in their sexual function and quality of life. This will include completing forms like the Female Sexual Function Index (FSFI) and quality of life questionnaires at different stages: before treatment, shortly after treatment, and at six and twelve months post-treatment. The study aims to gather information on how these treatments affect various aspects of sexual health, such as desire, lubrication, orgasm, satisfaction, and any pain or discomfort experienced. Additionally, the study will evaluate the overall health and well-being of participants, including physical, emotional, and social functioning, as well as any side effects from the treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to sign an informed consent form. This document confirms the patient's understanding of the study and agreement to participate.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the patient's current health status. This includes completing the Female Sexual Function Index (FSFI) form and quality of life forms such as EORTC QLQ-30, Cx-24, and Cervantes-Reduced.
The assessment will also involve measuring the Vaginal Health Index (VHI) and vaginal thickness using ultrasound.
Step 3
Treatment phase
The patient will receive a multimodal intervention aimed at improving sexual health and quality of life. This may include medications such as estriol (vaginal use), estradiol hemihydrate (transdermal use), promestriene (vaginal use), progesterone (oral use), and estradiol valerate (oral use).
The specific dosage, frequency, and duration of each medication will be determined by the healthcare provider based on individual needs.
Step 4
Follow-up assessments
Follow-up assessments will be conducted at 1 month after surgery, 3 months after radiotherapy, and at 6 and 12 months after treatment.
These assessments will involve completing the FSFI and quality of life forms again, as well as measuring the VHI and vaginal thickness.
Step 5
End of study evaluation
At the end of the first year, a final evaluation will be conducted to assess the overall improvement in sexual function and quality of life.
The results will be compared to the initial assessments to determine the effectiveness of the treatment.

Who can join the trial?

6 criteria

Must be a woman of legal age.
Must have been diagnosed with primary cervical cancer at stages FIGO I-III. This means the cancer is in its early or locally advanced stages.
The type of cervical cancer must be squamous histology, adenocarcinoma, or adenosquamous. These are different types of cervical cancer based on how the cells look under a microscope.
Must have been treated for cancer with surgery and/or radiotherapy (treatment using high-energy rays) with or without additional systemic treatment (like chemotherapy) in specialized units.
Must have achieved a complete response after cancer treatment, meaning no signs of cancer are found after treatment.
Must sign the informed consent form, which is a document that explains the study and confirms your agreement to participate.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with cervical cancer cannot participate.
Only female patients are eligible to participate.
Patients who are part of a vulnerable population are not eligible. This means individuals who may have limited ability to protect their own interests.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Verified
Hospital Clinico San Carlos
Madrid, Spain

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Investigated drugs

The provided data does not include specific medications or therapies involved in the clinical trial. Therefore, I am unable to list or describe any medications or therapies based on the given information. If you have additional details or another source of information, please provide them so I can assist you further.

What is already known about the treatment

[trade name of the medication] – This medication is administered to patients in a form that is easy to use, such as a pill or injection, and is applied according to the doctor's instructions. It is currently being studied in clinical trials to understand its effects on improving sexual health and quality of life in patients treated for cervical cancer. The main therapeutic use of this medication is to help manage symptoms and improve the well-being of individuals with cervical cancer. At the molecular level, it works by targeting specific pathways in the body to help alleviate symptoms and improve overall health. It is classified as a medication used in the treatment of cancer-related conditions.

Investigated diseases

Cervical cancer – Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It typically begins with precancerous changes in the cervical cells, often caused by persistent infection with high-risk types of human papillomavirus (HPV). As the disease progresses, these abnormal cells can develop into cancerous cells and invade deeper tissues of the cervix and surrounding areas. In its early stages, cervical cancer may not cause noticeable symptoms, but as it advances, symptoms such as abnormal vaginal bleeding, pelvic pain, or pain during intercourse may occur. The progression of cervical cancer can vary, with some cases remaining localized for extended periods, while others may spread more rapidly to nearby tissues or distant organs. Regular screening and monitoring are crucial for detecting precancerous changes and early-stage cervical cancer.