Use of GnRHa During Chemotherapy for Fertility Protection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2032-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomised, double-blinded, placebo-controlled, phase 3 study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Subjects are randomised to triptorelin (active arm) or placebo (control) given in parallel to the chemotherapy treatment for the cancer diagnosis. All personnel involved in the study, and subjects, except personnel preparing triptorelin/placebo at the local site and an unblinded monitor, will be blinded during the study. Unblinded research nurse at each site will prepare blinded triptorelin/placebo to subjects and a web-based randomisation system will be used to allocate of blinded triptorelin/placebo to subjects at randomisation and drug dispense during the treatment period.

Study Groups

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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

Group Type EXPERIMENTAL

Triptorelin Embonate

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Sodium Chloride solution 0.9%

Intervention Type DRUG

One injection compensating for 3 months' effect OR one injection compensating for 1 month' effect to maintain the study blind.

Interventions

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Triptorelin Embonate

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.

Intervention Type DRUG

Sodium Chloride solution 0.9%

One injection compensating for 3 months' effect OR one injection compensating for 1 month' effect to maintain the study blind.

Intervention Type DRUG

Other Intervention Names

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Pamorelin Placebo

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No