Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT06816095
Eligibility Criteria:
Inclusion Criteria:
* Adult women (\>=18 years old) with gynecological tumors treated with radiotherapy-chemotherapy.
* Cancer disease is stable or in remission.
* Life expectancy \> = 6 months.
* Patients included in the group of patients with pelvic pain must have a clinical, radiological, endoscopic, or histopathological diagnosis that their pain is not secondary to the oncological process.
* Patients included in the group of patients with pelvic pain must have pain for \>= 3 months duration, with an intensity \>= 3 on the Visual Analog Scale (VAS), or classified as toxicity \>= Grade-2 of the CTCAE v.5.0 of the National Cancer Institute of the USA.
* Signed and dated informed consent specific to this study.
Exclusion Criteria:
* Age \< 18 years old.
* Severe psychiatric disorders.
* Inability to complete the quality of life questionnaires.
* Active neoplasia requiring recent initiation (\< 3 months) of systemic or local treatment.
* Life expectancy (for any reason) \< 6 months.
* Failure to meet all inclusion criteria
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06816095
Study Brief:
Protocol Section:
NCT06816095