ESTRIOL for Cervical cancer

Inclusion criteria

• {"criterion_text":"- Women of legal age"}
• {"criterion_text":"- Patients with primary cervical cancer stage FIGO I-III (initial or locally advanced) of squamous histology, adenocarcinoma or adenosquamous."}
• {"criterion_text":"- Patients treated for cancer with surgery and/or radiotherapy ± systemic treatment in the Gynaecological Oncology Units of hospitals in Spain."}
• {"criterion_text":"- Complete response after oncospecific treatment was obtained."}
• {"criterion_text":"- Signature of the informed consent (IC) by the patient or responsible family member."}

Exclusion criteria

• {"criterion_text":"- Patients under 18 years of age"}
• {"criterion_text":"- Pregnancy or breastfeeding."}
• {"criterion_text":"- Partial response after completion of oncospecific treatment."}
• {"criterion_text":"- Patients with premalignant pathology."}
• {"criterion_text":"- Diagnosis of a tumor of non-cervical origin or atypical histologies."}
• {"criterion_text":"- Impossibility of completing the questionnaires included in the protocol autonomously."}
• {"criterion_text":"- Contraindications to the use of vaginal estrogens."}
• {"criterion_text":"- Patients undergoing fertility-sparing treatment (trachelectomy or conization)."}
• {"criterion_text":"- Patients undergoing palliative treatment."}

Primary endpoints

• {"endpoint_text":"- Global score on the FSFI (Female Sexual Function Index) form at the end of the first year after treatment.","definition_or_measurement_approach":"Global score measured using the FSFI questionnaire at 12 months (end of the first year) after treatment."}

Secondary endpoints

• {"endpoint_text":"- Score on the FSFI form at diagnosis, after treatment (defined as baseline level: 1 month after surgery and 3 months after treatment with radiotherapy ± systemic treatment), at 6 and 12 months after treatment. The score in each of the sexual response domains that make up the FSFI (subjective desire and stimulus, lubrication, orgasm, satisfaction, and pain or discomfort) will also be evaluated individually.","definition_or_measurement_approach":"FSFI total score and domain scores measured at diagnosis, baseline (1 month after surgery or 3 months after radiotherapy ± systemic treatment), 6 months and 12 months."}
• {"endpoint_text":"- Score on the quality of life forms (EORTC QLQ-30, Cx-24, Cervantes- Reduced) at diagnosis, after treatment (baseline level), at 6 months and 12 months after treatment. The score on each of the 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), the global health status scale and the 6 independent items of EORTC QLQ-30","definition_or_measurement_approach":"Quality of life measured by EORTC QLQ-30, Cx-24 and Cervantes-Reduced at diagnosis, baseline, 6 and 12 months; individual functional and symptom scale scores and global health status will be evaluated."}
• {"endpoint_text":"- Adherence to multimodal treatment in the intervention arm, defined as the percentage of patients in the intervention arm who have undergone each of the items included in the multimodal treatment.","definition_or_measurement_approach":"Adherence defined as percentage of intervention-arm patients who completed each component/item of the multimodal intervention."}
• {"endpoint_text":"- Adverse effects with the use of treatments, assessing their number, severity and type (A - Augmented; B - Bizarre)","definition_or_measurement_approach":"Assessment of adverse events by number, severity and specified type classification (A - Augmented; B - Bizarre)."}
• {"endpoint_text":"- Vaginal Health Index (VHI) score and thickness measured by ultrasound, for assessment of vaginal trophism at diagnosis, after treatment (baseline level), at 6 and 12 months after treatment.","definition_or_measurement_approach":"Vaginal trophism assessed using VHI score and vaginal wall thickness measured by ultrasound at specified time points (diagnosis, baseline, 6 and 12 months)."}

Spain

Latest Decision Or Authorization Date

09-05-2025

Number Of Sites

2

Number Of Participants

120

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain