RecruitingPhase 2ACTRN12609001059257

Women undergoing chemotherapy plus gonadotrophin-releasing hormone (GnRH) analouges compared with control to protect ovairan function

Gonadotropin-releasing hormone analogue cotreatment does not preserve ovarian function in young women receiving cyclophosphamide-based chemotherapy: a prospective, multicenter, randomized trial

Sponsor

Ass. Prof. Dr. Eman Elgindy

Enrollment

100 participants

Start Date

Dec 15, 2009

Study Type

Interventional

Conditions

Women of reproductive age receiving chemotherapy Cancer

Summary

Cancer is not uncommon in women of reproductive age. Women diagnosed with cancer during their reproductive period are often concerned not only with the uncertainty of long-term survival, but also with the potential loss of fertility as a result of cancer treatment. A combination of gonadotrophin-releasing hormone (GnRH) analogue administrations with cyclophosphamide-based chemotherapy may provide protection to the woman's ovaries during treatment. We wished to determine this in a multi-center, open label controlled trial of 100 reproductive age women needing chemotherapy.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a hormone treatment given alongside chemotherapy can protect the ovaries of young women with cancer from being damaged by the chemotherapy drugs. Losing ovarian function from cancer treatment can cause early menopause and infertility. Researchers hope that giving a hormone called a GnRH analogue at the same time as chemotherapy might shield the ovaries during treatment. You may be eligible if: - You are a woman between 18 and 40 years old - You have been diagnosed with cancer and need chemotherapy that includes a drug called cyclophosphamide - You have both ovaries - You do not have ovarian cysts larger than 40mm You may NOT be eligible if: - You have advanced or metastatic (spread) cancer - Your cancer involves the ovaries, uterus, or fallopian tubes - You have previously had chemotherapy or pelvic radiation - You are currently on hormone therapy, biologic therapy, or corticosteroids - You are pregnant or breastfeeding Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

As part of a multicenter randomized trial, participants will be stratified according to the timing of their first presentation(Women requiring early chemotherapy will be randomly allocated to receive

As part of a multicenter randomized trial, participants will be stratified according to the timing of their first presentation(Women requiring early chemotherapy will be randomly allocated to receive either early chemotherapy alone (EC Control) or GnRH-ant (Cetrotide0.25 mg, cetrorelix, Merck Serono, Switzerland) and GnRH-ag (Decapeptyl CR, triptorelin 3.75 mg, Ferring, Switzerland) combination followed by chemotherapy (EC GnRH) when down-regulation (E2<50 pg/ml) is confirmed with discontinuation of GnRH-ant and continuation of triptorelin every 4 weeks until end of chemotherapy When chemotherapy is planned to start later than 10 days, women will be randomized to receive either chemotherapy alone (DC Control) or GnRH-ag followed by chemotherapy (DC GnRH) after confirmation of down-regulation (E2<50 pg/ml) with continuation of agonist until end of chemotherapy. FAC regime will be used in all participants (IV 5-flourouracil (500\m2), adriamycin, (50mg\m2) and cyclophosphamide (500mg\m2) every 21 days for six cycle in absence of disease progression or toxicity. Adverse events will be assessed clinically and by means of hematologic and biochemical measurements. Lymph node dissection wil bel performed on a case-by-case basis. Regional adjuvant radiotherapy will be allowed.