Clinical trial NCT05462379: Autologous Heterotopic Fresh Ovarian Graft in Woman With LACC Eligible for Pelvic Radiotherapy Treatment.
Official title: Autologous Heterotopic Fresh Ovarian Graft in Young Woman With Locally Advanced Cervical Cancer Eligible for Pelvic Radiotherapy Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Cervical Carcinoma
Premature Ovarian Failure
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
Secondary outcomes:
measure: 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).
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo
Study officials:
References: