Many cytotoxic drugs may harm the fertility of young women treated for cancer. The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can preserve the fertility of young female cancer subjects. Approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment. The patients will be randomised in between treatment with triptorelin (experimental) or placebo (control) intramuscularly a 1:1 ratio during chemotherapy. The injections may be given once monthly or once three months depending on type of chemotherapy given. Randomisation and study drug is blinded, neither investigator, research nurse nor patient will know if it is active drug or placebo. The only person who knows is the nurse preparing the injection. Patients will be followed up to 5 years after end of treatment with physical examinations, vital signs, biochemical markers, bone mineral density exams, ultrasound for antral follicle counts and ovarian doppler flow, concomitant medications, adverse events and quality of life questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
500
11.25 mg will be given for subjects having at least 3 months gonadotoxic treatment, one injection of 11.25 mg will compensate for 3 months' effect of the study drug. 3.75 mg will be given for subjects during one-month of gonadotoxic treatment, one injection of 3.75 mg will compensate for 1 month' effect of the study drug.
One injection compensating for 3 months' effect OR one injection compensating for 1 month' effect to maintain the study blind.
Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth
Gothenburg, Sweden
NOT_YET_RECRUITINGCenter for Pediatric Oncology, Akademiska Hospital
Gothenburg, Sweden
NOT_YET_RECRUITINGDepartment of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden
NOT_YET_RECRUITINGDepartment of Hematology, Skåne University Hospital
Lund, Sweden
NOT_YET_RECRUITINGDepartment of Oncology, Skåne University Hospital
Lund, Sweden
NOT_YET_RECRUITINGDepartment of Pediatric Oncology, Skåne University Hospital
Lund, Sweden
NOT_YET_RECRUITINGDepartment of Oncology, Örebro University Hospital
Örebro, Sweden
ACTIVE_NOT_RECRUITINGKarolinska Univeristy Hospital, Breast Centre
Stockholm, Sweden
RECRUITINGDepartment of Hematology and coagulation, Sahlgrenska University Hospital
Stockholm, Sweden
NOT_YET_RECRUITINGDepartment of Hematology, Capio ST. Göran Hospital
Stockholm, Sweden
NOT_YET_RECRUITING...and 7 more locations
Anti-Müllerian Hormone (AMH) levels in women with breast cancer
To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH relative to AMH levels at EoT in women with breast cancer.
Time frame: 12 months after end of gonadotoxic chemotherapy and study drug treatment
Anti-Müllerian Hormone (AMH) levels in women with acute leukemias, lymphomas and sarcomas.
To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH relative to AMH levels at EoT in women with acute leukemias, lymphomas and sarcomas.
Time frame: 12 months after end of gonadotoxic chemotherapy and study drug treatment
Changes in ovarian reserve with or without Gonadotropin-Releasing Hormone agonist (GnRHa) by determination of the antral follicle counts (AFC)
Changes in AFC in women with breast cancer and with acute leukemia, lymphoma and sarcoma respectively
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months) and at 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT
Changes in ovarian reserve with or without GnRHa by longitudinal observation of AMH levels
The difference in recovery of AMH levels between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively
Time frame: At 6 months, 2 years, 3 years, 4 years and 5 years after EoT.
The proportion of females with or without GnRHa that develop ovarian insufficiency by determination of follicle stimulating hormone (FSH), inhibin and estradiol
Comparison of FSH, inhibin and estradiol between the GnRHa group and the placebo group
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of body mass index (BMI) (Kg/m2) on changes in ovarian reserve with or without GnRHa
longitudinal observation of AMH levels, FSH, inhibin and estradiol
Time frame: At Baseline, during treatment, at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of use of contraceptives (yes/no) in changes of ovarian reserve with or without GnRHa
longitudinal observation of AMH levels, FSH, inhibin and estradiol
Time frame: At Baseline, during treatment visits (every 1-3 months of gonadotoxic treatment), at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of endocrine adjuvant therapy (yes/no) in changes of ovarian reserve with or without GnRHa
longitudinal observation of AMH levels, FSH, inhibin and estradiol
Time frame: At Baseline, during treatment visits (every 1-3 months of gonadotoxic treatment), at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The effect of GnRHa with or without GnRHa on ovarian blood supply
Comparison of blood flow to the ovarian artery (right and left Doppler flow) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The proportion of females with or without GnRHa that develop amenorrhea (no menstruations)
Comparison of the proportion that develop amenorrhea (no menstruations) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Pregnacy wish after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Comparison of of pregnancy wish (Study specific questionaire) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Comparison of pregnancy attempts (Study specific questionaire) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At end of chemotherapy (corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Comparison of pregnancy outcome between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (EORTC QLQ C30)
Comparison of validated outcome on health-related QoL (EORTC QLQ C30) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (FSFI)
Comparison of validated outcome of sexuality and reproductive health (Female Sexual Function Index (FSFI)) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (HAD)
Comparison of validated outcome on health-related QoL (Hospital Anxiety and Depression Scale (HAD)) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The development of co-morbidities during follow-up and bone mineral density
Comparison of bone mineral density between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At baseline, at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months) and 12 months and 5 years after EoT
Disease-specific oncologic outcomes: disease-free survival
Investigation of disease-free survival between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Disease-specific oncologic outcomes: Recurrence rate
Investigation of recurrence rate between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Disease-specific oncologic outcomes: overall survival
Investigation of overall survival between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Time frame: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
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