Ovarian Failure Clinical Trial
Official title:
Phase II Study of Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide Containing Chemotherapy: Menstruation Outcome
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | March 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Premenopausal cancer patients who will receive Cyclophosphamide-containing chemotherapy. Exclusion Criteria: postmenopausal cancer patients. cancer patients who will receive non Cyclophosphamide containing chemotherapy. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | compare rate of ovarian failure at 1 year between the two treatment groups | rate of ovarian failure | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01197456 -
Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
|
||
Not yet recruiting |
NCT03674164 -
Fertility Preservation With Ovarian Tissue Freezing
|
N/A | |
Not yet recruiting |
NCT02280681 -
MAR With Artificial Gametes: Treatment Characteristics and Their Trade-offs Determining Treatment Preference
|
N/A | |
Completed |
NCT04776902 -
Effects of Ovarian Reserve on Sexual Satisfaction
|
N/A | |
Recruiting |
NCT04275700 -
Study of PRP in Women With Evidence of Diminished Ovarian Reserve
|
N/A | |
Completed |
NCT03398603 -
Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
|
||
Not yet recruiting |
NCT04306185 -
Ovarian Fragmentation Study (Crespo Medical Team)
|
N/A | |
Not yet recruiting |
NCT06426771 -
Effect of Antimullerian Hormone Levels on the Inflammatory Index, Phytochemical Index and NRF Nutrient Density
|
||
Enrolling by invitation |
NCT04009473 -
Stem Cell Therapy and Growth Factor Ovarian in Vitro Activation
|
Phase 1/Phase 2 | |
Completed |
NCT03040921 -
Uterine Transposition: Feasibility Study
|
N/A | |
Active, not recruiting |
NCT04444245 -
Ovarian Rejuvenation Using Platelet Rich Plasma (PRP) & Autologous Tissue Stromal Vascular Fraction (tSVF) and Cell Enriched tSVF
|
Phase 1 | |
Completed |
NCT06394466 -
Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy
|
||
Completed |
NCT03907618 -
Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes
|
||
Recruiting |
NCT05181748 -
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
|
Phase 2/Phase 3 | |
Completed |
NCT04024449 -
Can Celiac Disease Affect Ovarian Function in Adolescent?
|
||
Completed |
NCT04163640 -
Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response
|
N/A | |
Recruiting |
NCT05158933 -
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Ovarian Failure
|
Phase 1 |