Use of GnRHa During Chemotherapy for Fertility Protection

Sponsor
Kenny Rodriguez-Wallberg
Study ID
NCT05328258
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Leukemia
  • Breast Cancer Female
  • Ewing Sarcoma
  • Lymphoma
  • Osteosarcoma
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • Triptorelin Embonate — DRUG
    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.
  • Sodium Chloride solution 0.9% — DRUG
    One injection compensating for 3 months' effect OR one injection compensating for 1 month' effect to maintain the study blind.

Study Details

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.

Key Dates

First listed
Apr 14, 2022
Start date
Mar 31, 2023
Status verified
Oct 2023
Primary completion
Jan 1, 2028
Completion
Jan 31, 2032

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Triptorelin
    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
  • Placebo Comparator: Arm B: Placebo
    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.

Primary Outcome Measure

Anti-Müllerian Hormone (AMH) levels in women with breast cancer [ Time Frame: 12 months after end of gonadotoxic chemotherapy and study drug treatment ]

Central Contacts

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