Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000613909
Ethics application status
Approved
Date submitted
14/06/2011
Date registered
15/06/2011
Date last updated
27/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective study of antimullerian hormone as a potential predictor of chemotherapy induced menopause
Scientific title
A prospective study of antimullerian hormone (AMH) as a potential predictor of chemotherapy induced menopause in premenopausal women age 18-45 undergoing curative intent chemotherapy
Secondary ID [1] 262372 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy induced menopause 268077 0
Condition category
Condition code
Reproductive Health and Childbirth 268221 268221 0 0
Menstruation and menopause
Cancer 268222 268222 0 0
Breast
Cancer 268223 268223 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will be investigating the association between antimullerian hormone levels (AMH) and chemotherapy induced menopause. Antimullerian hormone levels will be assessed at baseline, at the second cycle of chemotherapy, third cycle of chemotherapy, final cycle of chemotherapy and then 12 months post completion of chemotherapy. Menstruation will be recorded throughout this period as an indicator of menopausal status. The total period of observation for each participant will be between 16-18 months depending on the duration of their chemotherapy course.
Intervention code [1] 266764 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 268962 0
The association between AMH level pre-chemotherapy with chemotherapy induced amenorrhea at 1 year post chemotherapy. AMH will be assessed using a serum assay.
Timepoint [1] 268962 0
AMH will be measured at baseline and 12 months following completion of chemotherapy. Menstrual function will be recorded prospectively throughout the trial in the patient menstrual diary.
Secondary outcome [1] 276700 0
Rate of change of AMH as a predictor of chemotherapy induced amenorrhoea. AMH level will be assessed using a serum assay.
Timepoint [1] 276700 0
In addition to the baseline measurement, AMH will also be measured at the second and third cycle of chemotherapy and the final cycle of chemotherapy to determine the rate of fall of AMH.
Secondary outcome [2] 276701 0
Incidence and severity of menopausal symptoms, assessed using the Menopause Symptom Scale Score, a 7 item scale.
Timepoint [2] 276701 0
Menopause symptom score to be calculated at baseline, second, third and final cycle of chemotherapy and 12 months post completion of chemotherapy.
Secondary outcome [3] 276702 0
Quality of life assessed using EORTC-QLQ-C30 Quality of life questionnaire.
Timepoint [3] 276702 0
Measured at baseline, second cycle of chemotherapy, third cycle of chemotherapy, final cycle of chemotherapy and at 12 months post completion of chemotherapy.

Eligibility
Key inclusion criteria
*Female planned for first line gonadotoxic chemotherapy defined as chemotherapy associated with >25% rates of ovarian failure. Examples of appropriate chemotherapy regimens includes: FAC, FEC, AC, AC-T, , FEC-D, TAC, TC, R-CHOP, ABVD and BEACOPP
* Cancer treated with curative intent
* Age 18-45
* Premenopausal defined as at least 2 menstrual cycles within 180 days of study enrolment or if recently ceased oral or implantable contraception gonadotropin levels within premenopausal range
* Able to provide informed consent
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* planned for long term GNRH analogue post chemotherapy
* hysterectomy and/or bilateral oophorectomy prior to commencement of chemotherapy
* pregnant at time of enrolment

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267248 0
Hospital
Name [1] 267248 0
Flinders Medical Centre Oncology Clinical Trials Unit
Country [1] 267248 0
Australia
Primary sponsor type
Individual
Name
Hilary Martin
Address
Flinders Medical Centre, Flinders Drive, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 266312 0
Individual
Name [1] 266312 0
Professor Bogda Koczwara
Address [1] 266312 0
Flinders Medical Centre, Flinders Drive, Bedford Park, SA 5042
Country [1] 266312 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269238 0
The Southern Adelaide Human Research Ethics Committee
Ethics committee address [1] 269238 0
Ethics committee country [1] 269238 0
Australia
Date submitted for ethics approval [1] 269238 0
15/03/2011
Approval date [1] 269238 0
05/04/2011
Ethics approval number [1] 269238 0
115.11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32743 0
Address 32743 0
Country 32743 0
Phone 32743 0
Fax 32743 0
Email 32743 0
Contact person for public queries
Name 15990 0
Dr Hilary Martin
Address 15990 0
Flinders Medical Centre, Flinders Drive, Bedford Park, SA 5042
Country 15990 0
Australia
Phone 15990 0
61-8 - 8204 8997
Fax 15990 0
61-8-8204 4997
Email 15990 0
[email protected]
Contact person for scientific queries
Name 6918 0
Dr Hilary Martin
Address 6918 0
Flinders Medical Centre, Flinders Drive, Bedford Park, SA 5042
Country 6918 0
Australia
Phone 6918 0
61-8 - 8204 8997
Fax 6918 0
61-8-8204 4997
Email 6918 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.