Use of GnRHa During Chemotherapy for Fertility Protection (ProFertil)

Kenny Rodriguez-Wallberg

Status and phase: Enrolling; Phase 3

Conditions: Osteosarcoma; Acute Leukemia; Breast Cancer Female; Soft Tissue Sarcoma; Lymphoma; Ewing Sarcoma

Treatments: Drug: Triptorelin Embonate; Drug: Sodium Chloride solution 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT05328258

ProFertil

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 14 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy
• Confirmed menarche
• ECOG performance status 0-1
• Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders

Exclusion criteria

• Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data
• Previous or planned bilateral oophorectomy
• Pregnancy or breastfeeding at time of start of chemotherapy
• Other malignancy diagnosed within the last five years
• Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia
• Known osteoporosis
• Known low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias
• Known or suspected allergy against triptorelin
• Direct radiation of the gonads previous or planned (TBI allowed)
• Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 2 patient groups, including a placebo group

Arm A: Triptorelin

Experimental group

Description:

Triptorelin given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment. The dose is ether 11.25 mg triptorelin given for subjects having at least 3 months gonadotoxic treatment, OR 3.75 mg for subjects during one-month of gonadotoxic treatment

Treatment:

Drug: Triptorelin Embonate

Arm B: Placebo

Placebo Comparator group

Description:

Placebo, 0.9% sodium chloride, given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment. The dose will be provided both as one injection compensating for 3 months' effect and one injection compensating for 1 month' effect to maintain the study blind.

Treatment:

Drug: Sodium Chloride solution 0.9%