Do gonadotrophin-releasing hormone (GnRH) agonists protect ovarian function in patients with Non-Hodgkin’s Lymphoma?

Phase 2

• Conditions: Ovarian function following chemotherapy; Non-Hodgkin's Lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12610000785000
• Lead Sponsor: Melbourne in vitro fertilization (IVF)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

women anticipated to receive 6 cycles of R-CHOP-14 with curative intent for Non-Hodgkin's Lymphoma (NHL)

- resident in Australia for the duration of trial participation

- a minimum of 12 months post-menarche and be less than or equal to 38 years at the start of treatment

- premenopausal state, as demonstrated by greater than and equal to 3 spontaneous menstrual cycles in the last 6 months or by non-menopausal levels of FSH or oestradiol at baseline

- ability to administer the first dose of Zoladex no later than 1 week after commencing chemotherapy

- consent to utilizing a progesterone-only contraceptive during their chemotherapy and also barrier contraception for 8 weeks prior to each follow up blood test

- ability to give informed consent. For patients under 18 years parental consent must be given, with patient assent where appropriate

Exclusion Criteria

- known contraindication to the use of a GnRH analogue (e.g. pregnancy or hypersensitivity) or a progesterone-only contraceptive

- anticipated requirement for pelvic irradiation as part of therapy

- radiological evidence of ovarian involvement with NHL

- prior cytotoxic chemotherapy for this or any other diagnosis

- contraindication to use of a progesterone-only contraceptive pill (e.g. previous history of thromboembolic disease)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Follicle stimulating hormone (FSH) assessed by blood serum analysis[6 months and 3 years post chemotherapy treatment];anti-mullerian hormone (AMH) assessed by blood serum analysis[6 months and 3 years post chemotherapy treatment]

Secondary Outcome Measures

Name	Time	Method
oestradiol (E2) assessed by blood serum analysis[6 months post chemotherapy, and then yearly for 5 years post chemotherapy treatment];inhibin B assessed by blood serum analysis[baseline, 6 months, 3 years post chemotherapy treatment];antral follicle counts and ovarian volume assessment by ultrasound[6 months post chemotherapy, and then yearly for 5 years post chemotherapy treatment];menstrual regularity diary[6 months post chemotherapy, and then yearly for 5 years post chemotherapy treatment];bone mineral density will be assesed using a calibrated and validated dual energy x-ray absorptiometry (DEXA) scan.[baseline, before chemotherapy treatment and at the end of chemotherapy treatment]