Autologous Heterotopic Fresh Ovarian Graft in Young Woman With Locally Advanced Cervical Cancer Eligible for Pelvic Radiotherapy Treatment
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Previous treatment for cervical cancer or other malignant diseases.
- •Rare histology tumors.
- •Absence of one or both ovaries.
结局指标
主要结局
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).
时间窗: 2 years
Endocrine functionality is defined as FSH levels under 25 mUI/ml.
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).
时间窗: 2 years
Endocrine functionality is defined as estradiol upper 47 pg/mL.
次要结局
- 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).(2 years)
- 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)
- 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.(2 years)
- 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).(2 years)
- 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).(2 years)
- 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).(2 years)
- 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).(2 years)
- 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.(2 years)
- 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)
研究者
MARILIA ALBANEZI BERTOLAZZI
Principal investigator/ Gynaecologist
Instituto do Cancer do Estado de São Paulo