Instituto do Cancer do Estado de São Paulo
São Paulo, 01246-000, Brazil
NCT Number: NCT05462379
Pelvic chemoradiotherapy (CRT) is an effective treatment for Locally Advanced Cervical Cancer (LACC). However, CRT induces premature ovarian failure ceasing the production of ovarian hormones. This may lead to severe consequences to the patient's life quality, sexuality and overall healthy. An acceptable treatment to minimize the adverse effects caused by the lack of ovarian hormones is hormonal replacement but less than 40% of the patients younger than 50 years have access to this treatment. A second alternative treatment is ovarian transposing which is a surgical technique with variable success rate depending on how far the ovaries are from the radiotherapy field. A third, more promising, alternative is involves using autologous ovarian tissue as a graft in tissues far from the radiotherapy field. This treatment has the potential of maintaining the natural ovarian hormones production at a lower-cost and requiring a simpler procedure. The primary objective of this randomized phase 1-2 clinical trial is to validate the feasibility of ovarian tissue engraft into fatty tissue and its endocrine functionality.
This study is active but is not currently recruiting participants.
Notify Me18 year–35 year
Female
Interventional
Phase 1 / Phase 2
São Paulo, 01246-000, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Before the beginning of pelvic radiotherapy, one of the ovaries will be removed by laparoscopy. Ovary slices of 1-2 mm will be prepared in sterile environment and engrafted in the fatty tissue of inner tight. One representative fragment will undergo histologic evaluation. These procedures will be done in the same surgical time.
Other names: Autologous Heterotopic Fresh Ovarian Graft
Time frame: 2 years
Endocrine functionality is defined as FSH levels under 25 mUI/ml.
Time frame: 2 years
Endocrine functionality is defined as estradiol upper 47 pg/mL.
Time frame: 2 years
Evaluation of glucose metabolism.
Time frame: 2 years
Evaluation of glucose metabolism.
Time frame: 2 years
Evaluation of lipid metabolism.
Time frame: 2 years
Evaluation of lipid metabolism.
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Evaluation of changes in body mass.
Time frame: 2 years
EORTC QLQ C30 was developed and validated to assess the quality of life of cancer patients.
The 30-item EORTC QLQ-C30 is a disease-specific measure that assesses multiple QoL domains in patients with cancer. There are five functioning scales that measure physical, role, emotional, cognitive, and social functioning. Three symptom scales measure fatigue, pain, and nausea/vomiting.
Time frame: 2 years
EORTC QLQ-CX24 Scoring Manual The Cervical Cancer Module is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The EORTC QLQ-CX24 was designed to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer.
MARILIA ALBANEZI BERTOLAZZI
Other
Autologous Heterotopic Fresh Ovarian Graft in Young Woman With Locally Advanced Cervical Cancer Eligible for Pelvic Radiotherapy Treatment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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