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Individualized Exercise Programs for Patients Receiving Chemotherapy for Newly Diagnosed Acute or Relapsed Myeloid Leukemia or Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2008

Sponsors and Collaborators: UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00499759
  Purpose

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
Depression
Fatigue
Leukemia
Musculoskeletal Complications
Psychosocial Effects/Treatment
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

MedlinePlus related topics:   Cancer    Depression    Exercise and Physical Fitness    Leukemia, Adult Acute    Leukemia, Adult Chronic   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other
Official Title:   In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Effects of an individualized prescriptive exercise intervention [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of developing an individualized prescriptive exercise program [ Designated as safety issue: No ]
  • Changes in cardiovascular endurance, muscular strength, and selected blood parameters [ Designated as safety issue: No ]
  • Response of inflammatory proteins to exercise [ Designated as safety issue: No ]
  • Fatigue, depression, and quality of life [ Designated as safety issue: No ]

Estimated Enrollment:   10
Study Start Date:   May 2007

Detailed Description:

OBJECTIVES:

Primary

  • Determine the effects, in terms of fitness and blood parameters, fatigue levels, and quality of life, of an individualized prescriptive exercise intervention in patients with newly diagnosed acute or relapsed myeloid or lymphoblastic leukemia undergoing chemotherapy.

Secondary

  • Determine the feasibility of developing an exercise program for these patients.
  • Assess the changes in cardiovascular endurance, muscular strength, selected blood parameters, and response of inflammatory proteins to exercise in these patients.
  • Evaluate fatigue, depression, and quality of life of these patients.

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.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute or relapsed myeloid or lymphoblastic leukemia

    • Currently receiving re-induction therapy or designated for chemotherapy treatment
  • Expected hospital stay of 3-4 weeks or longer
  • Participation in the study must be approved by the physician directly responsible for the patient's care while at University of North Carolina Hospitals

PATIENT CHARACTERISTICS:

  • No condition that would compromise the patient's ability to participate in the exercise rehabilitation program, including any of the following:

    • Immune deficiency
    • Acute or chronic bone, joint, or muscular abnormalities
    • Acute or chronic respiratory disease
    • Cardiovascular disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499759

Locations
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        

Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Claudio L. Battaglini, PhD     UNC Lineberger Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000551972, UNC-LCCC-0526
First Received:   July 10, 2007
Last Updated:   July 29, 2008
ClinicalTrials.gov Identifier:   NCT00499759
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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
Behavioral Symptoms
Lymphatic Diseases
Signs and Symptoms
Leukemia
Mental Disorders
Mood Disorders
Neoplasm Metastasis
Acute myeloid leukemia, adult
Lymphoproliferative Disorders
Congenital Abnormalities
Acute myelocytic leukemia
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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