Autologous Heterotopic Fresh Ovarian Graft in Woman With LACC Eligible for Pelvic Radiotherapy Treatment.

Premature Ovarian Failure Clinical Trial

Official title:

Autologous Heterotopic Fresh Ovarian Graft in Young Woman With Locally Advanced Cervical Cancer Eligible for Pelvic Radiotherapy Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462379
• Other study ID #: NP1782
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 8, 2022
• Est. completion date: June 8, 2024

Study information

• Verified date: March 2024
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Marilia Bertolazzi, MD
• Phone: 5519989172189
• Email: marilia.bertolazzi[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 8, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Pathologic diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix.
• FIGO 2018 staging IB3 to IVA.
• Absence of ovarian involvement.
• Age =35 Years.
• Absence of metastatic disease.
• Written consent.

Exclusion Criteria:

• Previous treatment for cervical cancer or other malignant diseases.
• Rare histology tumors.
• Absence of one or both ovaries.

Related Conditions & MeSH terms

• Locally Advanced Cervical Carcinoma
• Menopause, Premature
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Procedure:
• Ovarian graft
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.

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
MARILIA ALBANEZI BERTOLAZZI

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of serum levels of follicle stimulating hormone (FSH) in mUI/ml in intervention (engraft of ovarian tissue into fatty tissue) and control groups. Dosage will be performed at baseline and post radiotherapy (2, 6, 12 and 24 months).	Endocrine functionality is defined as FSH levels under 25 mUI/ml.	2 years
Primary	Dosage of serum levels of estradiol in pg/ml in intervention (engraft of ovarian tissue into fatty tissue) and control groups. . Dosage will be performed at baseline and post radiotherapy (2, 6, 12 and 24 months).	Endocrine functionality is defined as estradiol upper 47 pg/mL.	2 years
Secondary	Dosage of serum levels of glucose in mg/dL in intervention and control groups. (Time frame: At baseline and post radiotherapy month 2, 6, 12 and 24).	Evaluation of glucose metabolism.	2 years
Secondary	Measure of serum glycated hemoglobin in percentage in intervention and control groups. (Time frame: At baseline and post radiotherapy month 2, 6, 12 and 24).	Evaluation of glucose metabolism.	2 years
Secondary	Measure of serum levels of cholesterol in mg/dL in intervention and control groups. (Time frame: At baseline and post radiotherapy month 2, 6, 12 and 24).	Evaluation of lipid metabolism.	2 years
Secondary	Measure of serum levels of triglycerides in mg/dL in intervention and control groups. (Time frame: At baseline and post radiotherapy month 2, 6, 12 and 24).	Evaluation of lipid metabolism.	2 years
Secondary	Evaluate the changes in bone mineral density (BMD) in femoral neck and lumbar spine by bone densitometry, evaluating T and Z scores standard deviation (SD) in intervention and control groups. Time frame: At baseline and post radiotherapy month 12 and 24.		2 years
Secondary	Bioimpedance monitoring to evaluate changes in body composition by fat and lean mass percentage in intervention and control groups. Time frame: At baseline and post radiotherapy month 12 and 24).		2 years
Secondary	Quantification of body mass index reported in kg/m2 in intervention and control groups. Time frame: At baseline and post radiotherapy month 12 and 24).	Evaluation of changes in body mass.	2 years
Secondary	Score life quality in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) in intervention and control groups.	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.	2 years
Secondary	Score life quality in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Cervical Cancer Module (EORTC QLQ C30 CX24) in intervention and control groups.	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.	2 years