Clinical trial NCT00499759: Individualized Exercise Programs for Patients Receiving Chemotherapy for Newly Diagnosed Acute or Relapsed Myeloid Leukemia or Lymphoblastic Leukemia
Official title: In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Fatigue
Leukemia
Musculoskeletal Complications
Psychosocial Effects of Cancer and Its Treatment
Keywords: fatigue
depression
psychosocial effects of cancer and its 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
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Effects of an individualized prescriptive exercise intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of subjects experiencing fatigue, depression, and quality of life issues
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Claudio L. Battaglini, PhD
role: PRINCIPAL_INVESTIGATOR
References: