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

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


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.



- 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



Cardiac Toxicity


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


Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
United States


Active, not recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


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

Clinical Trials [6399 Associated Clinical Trials listed on BioPortfolio]

Hepatitis C Self-Management

The objective of this study is to compare the efficacy of a 6-session hepatitis C self-management workshop to a hepatitis C self-management self-study program. Both interventions are desig...

Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease. PURPOSE: This phase I trial ...

Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

RATIONALE: A stress-management program may improve quality of life and reduce anxiety and depression in patients receiving chemotherapy for cancer. PURPOSE: This randomized clinical trial...

Evaluating a Clinician Support Algorithm to Enhance Implementation of Evidence-Based Chemotherapy-Induced Peripheral Neuropathy Assessment and Management Recommendations

This research study is evaluating how well a decision support tool works to improve clinicians' use of recommended chemotherapy-induced peripheral neuropathy (CIPN) assessment and manageme...

Resilience Skills Self-Management for Chronic Pain.

The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT se...

PubMed Articles [28595 Associated PubMed Articles listed on BioPortfolio]

Test-retest and inter-rater reliability of the Danish version of the management of everday technology assessment for use with older adults with and without COPD.

The trend towards telemedicine increasingly requires clients to manage everyday technology (ET) to access and use health services. The Management of Everday Technology Assessment (META) is an observat...

Oxygen therapy in adult patients. Part 2: promoting safe and effective practice in patients' care and management.

The assessment, care and management of patients requiring oxygen therapy are key aspects of a nurse's role. Although oxygen therapy is an important treatment for many clinical conditions, it carries r...

Impact of a Standardized Clinical Assessment and Management Plan (SCAMP®) on growth in infants with CHD.

Growth failure is prevalent among infants with CHD. A Standardized Clinical Assessment and Management Plan was introduced at Boston Children's Hospital's cardiac medical ward to identify patients with...

The Investigation and Management of Adenomyosis in Women Who Wish to Improve or Preserve Fertility.

The management of adenomyosis remains a great challenge to practicing gynaecologists. Until recently, hysterectomy has been the only definitive treatment in women who have completed child bearing. A n...

Approach to the Assessment and Management of Adult Patients With Atopic Dermatitis: A Consensus Document. Section IV: Treatment Options for the Management of Atopic Dermatitis.

The objectives of therapy for atopic dermatitis (AD) are to reduce skin inflammation and pruritus, restore skin barrier function, and improve quality of life (QoL). Treatments can be classified as moi...

Medical and Biotech [MESH] Definitions

The assessment, treatment, and management of soft tissue injury or dysfunction. Therapy is designed to reduce tension and irritation in affected tissues and may include MASSAGE; muscle stretching, or direct pressure on muscles, connective tissue, and TRIGGER POINTS.

A measure of the quality of health care by assessment of unsuccessful results of management and procedures used in combating disease, in individual cases or series.

The management of all procurement, distribution, and storage of equipment and supplies, as well as logistics management including laundry, processing of reusables, etc.

Participation of employees with management as a labor-management team, in decisions pertaining to the operational activities of the organization or industry.

Business management of medical and dental practices that may include capital financing, utilization management, and arrangement of capitation agreements with other parties.

More From BioPortfolio on "Long-Term Effects of Therapy in Patients Previously Treated for Childhood Soft Tissue Sarcoma"

Quick Search


Relevant Topics

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...

Searches Linking to this Trial