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Long-Term Effects of Therapy in Patients Previously Treated for Childhood Soft Tissue Sarcoma

2014-07-23 21:55:51 | BioPortfolio

Summary

RATIONALE: Assessing the long-term effects of therapy in patients who have been treated for childhood soft tissue sarcoma may help improve the effectiveness of follow-up programs.

PURPOSE: Study to determine the long-term effects of therapy in patients who were previously treated for childhood soft tissue sarcoma.

Description

OBJECTIVES:

- Determine the incidence and degree of functional musculoskeletal impairment, late cardiac dysfunction induced by doxorubicin, gonadal dysfunction induced by alkylator-based chemotherapy and/or radiotherapy, and metabolic stress syndrome induced by dose-intensive chemotherapy in patients previously treated for pediatric sarcoma.

- Determine whether these patients have diminished bone mineral density.

- Correlate gonadal dysfunction and metabolic stress syndrome with loss of bone mass in these patients.

- Determine the quality of life of these patients.

- Determine the frequency and patterns of adaptational and adjustment difficulties with distinction of clinical or subclinical psychiatric illness in these patients.

- Determine myocardial tissue changes associated with anthracycline therapy and the cardiac function of patients treated with or without the cardioprotectant dexrazoxane.

- Determine the incidence and frequency of secondary malignancies, hepatitis B, C, or HIV seroconversion, and ifosfamide-related renal dysfunction in these patients.

- Determine the T-cell depletion following chemotherapy in these patients.

OUTLINE: Patients undergo evaluation of the following: cardiac dysfunction by echocardiogram, MUGA scan, and cardiac MRI with gadolinium texaphyrin contrast; gonadal dysfunction by physical examination, endocrine testing, and semen analysis; hormonal stress by serum hormone levels; musculoskeletal impairment by bone densitometry and musculoskeletal and functional testing by rehabilitation medicine specialists; transfusion-associated risks by hepatitis A, B, C, HIV, and HTLV-1 testing; and other major organ impairments.

Quality of life and psychosocial effects (including post-traumatic stress syndrome) are also assessed.

PROJECTED ACCRUAL: Approximately 50-100 patients will be accrued for this study within 1-2 years.

Study Design

N/A

Conditions

Cardiac Toxicity

Intervention

metabolic assessment, fertility assessment and management, management of therapy complications, psychosocial assessment and care, quality-of-life assessment

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
United States
20892-1182

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:55:51-0400

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