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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00499759 |
RATIONALE: An individualized exercise program may be effective in lessening fatigue and depression and improving quality of life in patients undergoing chemotherapy for leukemia.
PURPOSE: This clinical trial is studying how well individualized exercise programs work in patients receiving chemotherapy for newly diagnosed acute or relapsed myeloid leukemia or lymphoblastic leukemia.
Condition | Intervention |
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Cancer-Related Problem/Condition Fatigue Leukemia |
Procedure: chemotherapy Procedure: exercise intervention Procedure: fatigue assessment and management Procedure: laboratory biomarker analysis Procedure: management of therapy complications Procedure: musculoskeletal complications management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Study Type: | Interventional |
Official Title: | In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy |
Estimated Enrollment: | 10 |
Study Start Date: | May 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Patients participate in an individualized prescriptive exercise intervention 3 to 4 times per week for 6 weeks (4 weeks in hospital, 2 weeks at home). Exercise begins concurrently with the first course (induction therapy) of chemotherapy. Each exercise session consist of 3-5 minutes of light stretching (stretching component), 5-10 minutes of cycling on the recumbent bicycle (cardiorespiratory component), 5-15 minutes of resistance training including hand dumbbells, exercise tubing, rubber bands, and fit balls (resistance training component), and 5-10 minutes of abdominal exercises (core muscles component).
Quality of life, fatigue, and depression are assessed at baseline and weekly during study intervention.
Blood samples are collected at baseline and at weeks 3 and 6 for cytokine analysis.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed acute or relapsed myeloid or lymphoblastic leukemia
PATIENT CHARACTERISTICS:
No condition that would compromise the patient's ability to participate in the exercise rehabilitation program, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 |
Principal Investigator: | Claudio L. Battaglini, PhD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000551972, UNC-LCCC-0526 |
Study First Received: | July 10, 2007 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00499759 |
Health Authority: | Unspecified |
fatigue depression psychosocial effects/treatment musculoskeletal complications acute undifferentiated leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) |
adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia recurrent adult acute myeloid leukemia secondary acute myeloid leukemia recurrent adult acute lymphoblastic leukemia |
Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Fatigue Depression Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Depressive Disorder Recurrence |
Acute lymphoblastic leukemia, adult Lymphatic Diseases Leukemia Signs and Symptoms Neoplasm Metastasis Acute myeloid leukemia, adult Lymphoproliferative Disorders Congenital Abnormalities Acute myelocytic leukemia Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |