Sarcoma Clinical Trial
Official title:
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
Verified date | February 2017 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of pediatric cancer patients.
Status | Completed |
Enrollment | 149 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 30 Years |
Eligibility |
Inclusion Criteria: 1. Patients between the ages of 1 and 30 years with: - Acute lymphoblastic leukemia/lymphoma - Malignant brain tumor - Non-CNS solid tumors - Acute myeloblastic leukemia - Non-Hodgkin's lymphoma Hodgkin's disease - Head and Neck tumors 2. Patients MUST also be ready to receive a cycle of chemotherapy that predictably renders neutropenia at least 70% of the time OR has a risk of febrile neutropenia of at least 20%. This can be any cycle number, it does NOT need to be the FIRST cycle of chemotherapy they are to receive. Exclusion Criteria: - Patients receiving myeloablative chemotherapy in preparation for allogeneic or autologous bone marrow or stem cell transplant. - Co-morbidity with immunosuppressive disease such as AIDS. - Asplenia. - Patients with documented infection at time of enrollment. - Patients who are not fed orally (G-tube dependant, TPN-dependant). - Patients actively receiving radiation to the brain or gastrointestinal tract for sarcoma. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital at Montefiore | Bronx | New York |
United States | Maimonides Medical Center | Brooklyn | New York |
United States | Riley Hospital for Children at IU Health | Indianapolis | Indiana |
United States | Mount Sinai Medical Center | New York | New York |
United States | NYU Langone Medical Center | New York | New York |
United States | Rady Children's Hospital San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neutropenic Infection | approximately 4 weeks | ||
Secondary | Documented Infection | approximately 4 weeks | ||
Secondary | Quality of life | Baseline and at study end |
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