Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380406
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2006-09-23
Brief Title:
PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial A Randomized Controlled Trial of Gonadotropin Releasing Hormone Agonist GnRHa for Fertility Preservation in Oncology Patients
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROOF
Brief Summary:
The purpose of this study is to determine whether gonadotropin releasing hormone agonists medical therapy will protect against ovarian failure in reproductive aged women undergoing sterilizing chemotherapy
Detailed Description:
Fertility preservation is defined as the maintenance of ones ability to reproduce
The hypothesis for this study is that medical treatment GnRHa will help female cancer patients receiving sterilizing chemotherapy preserve their ovarian function and therefore fertility This study is a feasibility trial of the drug GnRHavs placebo in female cancer patients receiving gonadotoxic chemotherapy between the ages of 18 and 38 who wish to participate
The objective of the feasibility trial is to determine the feasibility of a definitive study to answer this question and also to define the required parameters needed to design the definitive study such as the observable difference in ovarian failure between the drug and placebo groups The same protocol will be followed as proposed for the definitive trial but with a smaller sample size
This pilot study will be conducted at the Ottawa Hospital Regional Cancer CentreDivision of Reproductive Medicine of Department of Obstetrics and Gynecology University of Ottawa and the Cancer Centre of Southeastern OntarioDivision of Reproductive Medicine of Department of Obstetrics and Gynecology University of Ottawa
The planned trial intervention is trimonthly every 3 months administration of depot GnRHa Leuprolide acetate LA 1125 mg intramuscularly or placebo Injections would start prior to initiation of chemotherapy in the luteal phase of the menstrual cycle preceding chemotherapy and will continue until cessation of chemotherapy maximum of 6 months or 2 injections Since only adjuvantcurative chemotherapy patients will be enrolled chemotherapy will last a maximum of six months
Subjects will be randomized with concealed allocation to either GnRHa or placebo Subjects and investigators will be blinded to the intervention administered
Inclusion criteria Women who are
1 between ages 18 to 38
2 who will be undergoing gonadotoxic sterilizing curative adjuvant chemotherapy for early stage disease and
3 have provided informed consent All subjects will be enrolled from the Ottawa Hospital Regional Cancer Institute OHRCC and the Cancer Center of South Eastern Ontario at Kingston General Hospital CCSEO Gonadotoxic chemotherapy includes alkylating anthracycline agents eg cyclophosphamide
Exclusion criteria Women who
1 have advanced stage disease andor whose median survival is expected to be less than 6 months
2 have cancer of the ovaries uterus or fallopian tubes
3 have clinical or biochemical evidence of diminished ovarian reserve recent shortening of cycles lt 24 days between menses age gt 38 elevated serum FSH follicular stimulating hormonegt 15 IUL or low antral follicle count AFC- number of follicles less than 10 mm on day 2 or 3 of natural menses on baseline pelvic ultrasound lt5 or elevated day 2 or 3 estradiol gt 280 pmolml
4 have previously received chemotherapy or abdominalpelvic radiation or have planned to receive abdominopelvic radiation
5 are pregnant
6 have contraindications to intramuscular injections or 7 have a history of fractures secondary toor documented osteoporosis
Outcomes Subjects will be assessed at baseline monthly for adverse effects only during active intervention and at 0 3 6 9 and 12 months post cessation of chemotherapy and treatment GnRHa placebo for predictors of ovarian reserve
The primary outcome is protection against ovarian failure at 12 months post chemotherapy This is measured by resumption of regular menstrual cycles every 24 -35 days with documentation of ovulation by biochemistry progesterone levels over a minimum of three months
Secondary outcomes will include sonographic biophysical and biochemical markers of ovarian reserve
The hypothesis for this study is that medical treatment GnRHa will help female cancer patients receiving sterilizing chemotherapy preserve their ovarian function and therefore fertility This study is a feasibility trial of the drug GnRHavs placebo in female cancer patients receiving gonadotoxic chemotherapy between the ages of 18 and 38 who wish to participate
The objective of the feasibility trial is to determine the feasibility of a definitive study to answer this question and also to define the required parameters needed to design the definitive study such as the observable difference in ovarian failure between the drug and placebo groups The same protocol will be followed as proposed for the definitive trial but with a smaller sample size
This pilot study will be conducted at the Ottawa Hospital Regional Cancer CentreDivision of Reproductive Medicine of Department of Obstetrics and Gynecology University of Ottawa and the Cancer Centre of Southeastern OntarioDivision of Reproductive Medicine of Department of Obstetrics and Gynecology University of Ottawa
The planned trial intervention is trimonthly every 3 months administration of depot GnRHa Leuprolide acetate LA 1125 mg intramuscularly or placebo Injections would start prior to initiation of chemotherapy in the luteal phase of the menstrual cycle preceding chemotherapy and will continue until cessation of chemotherapy maximum of 6 months or 2 injections Since only adjuvantcurative chemotherapy patients will be enrolled chemotherapy will last a maximum of six months
Subjects will be randomized with concealed allocation to either GnRHa or placebo Subjects and investigators will be blinded to the intervention administered
Inclusion criteria Women who are
1 between ages 18 to 38
2 who will be undergoing gonadotoxic sterilizing curative adjuvant chemotherapy for early stage disease and
3 have provided informed consent All subjects will be enrolled from the Ottawa Hospital Regional Cancer Institute OHRCC and the Cancer Center of South Eastern Ontario at Kingston General Hospital CCSEO Gonadotoxic chemotherapy includes alkylating anthracycline agents eg cyclophosphamide
Exclusion criteria Women who
1 have advanced stage disease andor whose median survival is expected to be less than 6 months
2 have cancer of the ovaries uterus or fallopian tubes
3 have clinical or biochemical evidence of diminished ovarian reserve recent shortening of cycles lt 24 days between menses age gt 38 elevated serum FSH follicular stimulating hormonegt 15 IUL or low antral follicle count AFC- number of follicles less than 10 mm on day 2 or 3 of natural menses on baseline pelvic ultrasound lt5 or elevated day 2 or 3 estradiol gt 280 pmolml
4 have previously received chemotherapy or abdominalpelvic radiation or have planned to receive abdominopelvic radiation
5 are pregnant
6 have contraindications to intramuscular injections or 7 have a history of fractures secondary toor documented osteoporosis
Outcomes Subjects will be assessed at baseline monthly for adverse effects only during active intervention and at 0 3 6 9 and 12 months post cessation of chemotherapy and treatment GnRHa placebo for predictors of ovarian reserve
The primary outcome is protection against ovarian failure at 12 months post chemotherapy This is measured by resumption of regular menstrual cycles every 24 -35 days with documentation of ovulation by biochemistry progesterone levels over a minimum of three months
Secondary outcomes will include sonographic biophysical and biochemical markers of ovarian reserve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None