Late Effects of Treatment for Sarcomas in Children
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|ClinicalTrials.gov Identifier: NCT00006515|
Recruitment Status : Completed
First Posted : November 22, 2000
Last Update Posted : July 2, 2017
This study will examine late effects of treatment for sarcoma (bone and soft tissue cancers) in children. Survival of patients with these diseases has improved over the years, but long-term adverse effects of treatment have also been noted.
Patients previously treated for sarcoma in the NCI's Pediatric Oncology Branch who are in their first remission from sarcoma after completion of therapy and who have had no further cancer treatment (chemotherapy, radiation therapy, cancer related surgery or immunotherapy) for at least 24 months may be eligible for this 3- to 4-day study. It will review the incidence and extent of the following late effects of therapy.
- Heart problems-The chemotherapy drug doxorubicin can cause acute and late injuries to the heart muscle. Patients will undergo magnetic resonance imaging (MRI) of the heart to look for changes and compare the findings with information obtained by standard echocardiogram (ultrasound test of the heart) and by MUGA (nuclear medicine scan of the heart).
- Gonadal dysfunction-The chemotherapy drug cyclophosphamide may affect sex hormone production, leading to infertility, early menopause or brittle bones. Low sex hormone levels may also increase the risk for heart attack, obesity or fracture. Patients will have blood tests to measure hormone levels as well as mineral levels, lipid levels and blood cell counts. They will also have a DEXA scan to measure bone mineral density and a CT scan of the abdomen to evaluate the distribution of fatty tissue in the abdomen. Males will be offered a semen analysis as part of the fertility evaluation.
- Psychosocial problems- Cancer diagnosis and treatment pose a major life stress that can lead to problems with personal relationships, jobs, insurance, education, health care, and personal and professional goal setting. Some patients may become depressed or develop a psychiatric illness. Patients will fill out a questionnaire about their treatment, recovery, and aspects of their current life and will meet with a psychologist and psychiatrist.
- Changes in bodily function and capabilities-Patients who undergo surgery and radiation to treat sarcoma treatment may experience muscle, bone and joint changes. Patients will be interviewed about their performance of daily activities, physical limitations, and changes in skill levels. They will do a series of exercises and will have measurements of strength, mobility and physical skills, focusing on the parts of the body that were affected by the sarcoma and subsequent local therapy.
- Exposure to viruses-A number of patients received blood transfusions as part of their cancer treatment. Some transfusions were given before HIV screening became available. Patients will be tested for this virus as well as the hepatitis virus and HTLV-1 (human T-cell leukemia virus-1), for which there are also small transfusion-associated risks.
- Kidney function-The chemotherapy drug ifosfamide may affect kidney function. Patients will provide a urine specimen for kidney function tests.
- Immune function-Chemotherapy affects the function of infection-fighting immune cells called T-lymphocytes. A blood sample will be drawn for studies of the time involved in recovering full immune function.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Late Effects of Treatment in Survivors of Pediatric Sarcomas|
|Study Start Date :||November 16, 2000|
|Estimated Study Completion Date :||November 18, 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006515
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|