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To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy
Design:
Study will be prospective interventional simple randomized control parallel open label Arms and Interventions Arm 1: Goserelin plus standard chemotherapy Goserelin will be given as a 3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months (26) Arm 2 (control Arm): Standard chemotherapy Patients will take only standard chemotherapy for 3 months Setting: oncology department Beni Suef university hospital Sample size: 80 patients (based on the results from the literature and to ensure a power of 80% and a type I error probability of 5%. we calculate Effect size Primary Outcome Measures
Evaluating ovarian function by: at the start of treatment and after 3 cycles chemotherapy treatment and at end of 6 cycles chemotherapy through:
Secondary Outcome Measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goserelin arm | Other | 3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months |
|
| control Arm | Other | Standard chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goserelin | Drug | chemotherapy+goserelin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| prevention premature ovarian failure | Evaluating ovarian function by FSH,E2 levels | 6 month from start of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| overall response in lymphoma patients | Overall response rate determined by tumor assessments from radiological tests including one of the following (computed tomography scan, Magnetic resonance imaging Positron-emission tomography or physical examinations , ( RECIL 2017) The overall response evaluation criteria in lymphoma, criteria categorized patients stable disease,progressive disease ,minor response,partial response,complete response at end of 6 months. |
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Inclusion Criteria:
Female lymphoma patients will be included in the study if they meet the following criteria:
Exclusion criteria:
The patients will be excluded from the study if they have the following criteria:
woman age 17-40 years
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Abdullah Elberry Elberry, MD | Assistant Professor of Clinical Pharmacology, Beni-Suef University | Study Director |
| Raghda Roshdy Sayed Hussein, MD | Lecturer of Clinical pharmacy, Beni-Suef University | Study Director |
| ahmed hassan shaaban | Lecturer of Clinical Oncology, Beni-Suef University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni Suef university | Al Fayyum | Mesala | 11858 | Egypt |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D004358 | Drug Therapy |
| D000971 | Antineoplastic Combined Chemotherapy Protocols |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy
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| Chemotherapy | Drug | standard chemotherapy |
|
|
| 6 month |
| ADVERSE EFFECTS | Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches) | 6 MONTH |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013812 | Therapeutics |
| D024221 | Antineoplastic Protocols |
| D002985 | Clinical Protocols |
| D004359 | Drug Therapy, Combination |