Trial record 4 of 267 for:    Lymphoma AND (women OR woman OR female)

Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00402935
First received: November 21, 2006
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before, during, and after chemotherapy may help doctors learn about the side effects of chemotherapy and help plan the best treatment.

PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women undergoing chemotherapy for cancer.


Condition Intervention
Leukemia
Long-term Effects Secondary to Cancer Therapy in Adults
Long-term Effects Secondary to Cancer Therapy in Children
Lymphoma
Sexual Dysfunction and Infertility
Sexuality and Reproductive Issues
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Other: laboratory biomarker analysis
Procedure: fertility assessment and management
Procedure: management of therapy complications
Procedure: ultrasound imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Incidence of ovarian damage after cytotoxic chemotherapy as determined by changes in ovarian volume, antral follicle count, and follicle-stimulating hormone, estradiol, and inhibin B levels [ Time Frame: Ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.


Enrollment: 0
Study Start Date: February 2004
Study Completion Date: May 2007
Intervention Details:
    Other: laboratory biomarker analysis
    Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
    Procedure: fertility assessment and management
    Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
    Procedure: management of therapy complications
    Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.
    Procedure: ultrasound imaging
    Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
Detailed Description:

OBJECTIVES:

  • Determine the incidence and timing of ovarian dysfunction/damage in younger premenopausal women undergoing cytotoxic chemotherapy for cancer.
  • Determine the feasibility of a prospective, randomized study to assess if gonadotropin analogues can protect the ovary from the cytotoxic effects of chemotherapy.
  • Determine the number of patients required for adequate power to test the hypothesis.

OUTLINE: This is a pilot, prospective study.

Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels. Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   14 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

premenopausal women undergoing chemotherapy for cancer

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer, including, but not limited to, any of the following:

    • Acute lymphocytic leukemia
    • Acute myeloid leukemia
    • Hodgkin's lymphoma
  • Must have primary disease with significant chance for long-term survival after therapy
  • Scheduled to receive chemotherapeutic agents known to be associated with ovarian failure, including any of the following:

    • Cyclophosphamide
    • Mechlorethamine hydrochloride
    • Busulfan
    • Procarbazine hydrochloride
    • Chlorambucil
    • Melphalan
    • Ifosfamide
    • Cisplatin
    • Carboplatin
  • Postmenarchal and premenopausal

PATIENT CHARACTERISTICS:

  • Female
  • Weight ≤ 250 pounds
  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • No prior or concurrent total-body irradiation or radiotherapy to the pelvis
  • Concurrent bone marrow transplantation allowed
  • Concurrent oral contraception and/or gonadotropin releasing-hormone analogue allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402935

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Marjorie Greenfield, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Marjorie Greenfield, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00402935     History of Changes
Other Study ID Numbers: CWRU3803, P30CA043703, CASE-CWRU-3803, CASE-01-04-15
Study First Received: November 21, 2006
Last Updated: March 16, 2012
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
stage I adult Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
long-term effects secondary to cancer therapy in adults
long-term effects secondary to cancer therapy in children
sexual dysfunction and infertility
sexuality and reproductive issues
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
adult acute myeloid leukemia in remission
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
secondary acute myeloid leukemia
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
childhood acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities

Additional relevant MeSH terms:
Lymphoma
Genital Diseases, Female
Infertility
Leukemia
Sexual Dysfunctions, Psychological
Neoplasms
Genital Diseases, Male
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014