Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide
- Registration Number
- NCT03475758
- Lead Sponsor
- Assiut University
- Brief Summary
The use of adjuvant chemotherapy in younger women with early breast cancer (EBC) has substantially improved the long-term outcome. However, this benefit is associated with long-term toxic effects which are becoming more important as prognosis improves. These include premature menopause and infertility in young pre-menopausal women. The incidence of premature menopause depends on the type and intensity of chemotherapy and the patient's age. In women \<35 years old, the long-term (3 years after diagnosis) incidence of amenorrhea is similar to women who have not received chemotherapy, at ∼ 10%, but this increases to 50% in women between 35 and 40 years old, and can be up to 85% in women \>40 years. Premature ovarian failure has major consequences including sexual dysfunction and infertility, and the latter may be of great concern to younger patients with breast cancer and has a bearing in influencing treatment decisions in almost 30% of cases.
Currently, there is no standard treatment for preventing chemotherapy-induced ovarian failure. Previous studies have suggested that temporary ovarian suppression with a gonadotropin-releasing hormone (GnRH) analogue may preserve ovarian function both in humans and animal models. Clinical data are conflicting. For example, a recent Italian multi-center phase III study Prevention of Menopause-Induced by Chemotherapy: A Study in Early Breast Cancer Patients-Gruppo Italiano Mamella 6 (PROMISE-GIM6) reported that the use of GnRH analogue, triptorelin during chemotherapy in pre-menopausal patients with EBC, reduced the occurrence of chemotherapy-induced early menopause with four pregnancies after a 26-month follow-up \[one in the chemotherapy alone arm and three in the triptorelin with chemotherapy arm\]. In contrast, another trial suggested that the use of goserelin concurrently with neoadjuvant chemotherapy did not significantly reduce incidence of amenorrhea 6 months after the end of chemotherapy compared with those receiving chemotherapy alone and only two pregnancies were recorded \[one in each arm\] with a follow-up of 2 years.
- Detailed Description
In this phase II trial, patients will be randomly assigned, in a 1:1 ratio, to standard adjuvant or neoadjuvant chemotherapy with the GnRH agonist goserelin (goserelin group) or to chemotherapy without goserelin (chemotherapy alone group).
For Patients randomly assigned to the goserelin group, goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks beginning 1 week before the initial chemotherapy dose and will be continued to within 2 weeks before or after the final chemotherapy dose.
Follow up: All patients will be followed for at least 1 year clinically monthly and by laboratory assessment by hormonal profile (FSH, LH, E2) every 6 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
Premenopausal cancer patients who will receive Cyclophosphamide-containing chemotherapy.
postmenopausal cancer patients. cancer patients who will receive non Cyclophosphamide containing chemotherapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description chemotherapy with goserelin Goserelin these patients will receive their chemotherapy with addition of Goserelin
- Primary Outcome Measures
Name Time Method compare rate of ovarian failure at 1 year between the two treatment groups 1 year rate of ovarian failure
- Secondary Outcome Measures
Name Time Method