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A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00445731
  Purpose

RATIONALE: A walking program may improve the ability to carry out daily activities after donor bone marrow transplant.

PURPOSE: This randomized clinical trial is studying a structured walking program to see how well it works compared with standard therapy in cancer patients undergoing a donor bone marrow transplant.


Condition Intervention
Cancer
Procedure: exercise intervention
Procedure: management of therapy complications
Procedure: observation

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Bone Marrow Transplantation Breast Cancer Cancer Exercise and Physical Fitness Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized
Official Title: A Randomized Trial of the Effect of a Walking Regimen on the Functional Status of Adult Allogeneic Donor Bone Marrow Transplant Patients

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

Primary Outcome Measures:
  • Difference in functional status as measured by Karnofsky performance scores at day 0 of allogeneic bone marrow transplantation and at day 100 post-transplantation

Secondary Outcome Measures:
  • Survival at day 100 and at 1 year post-transplantation
  • Patient satisfaction with the suggested exercise regimen as measured by the Wilcoxon test using a 5-point rating scale

Estimated Enrollment: 90
Detailed Description:

OBJECTIVES:

Primary

  • Compare the effects of a structured walking regimen vs normal standard care on functional status at day 100 after allogeneic bone marrow transplantation in patients with cancer.

Secondary

  • Compare the effects of these regimens on patient survival at day 100 and at 1 year after transplantation.
  • Compare patient satisfaction with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention arms.

  • Arm I: Beginning 2-3 days after allogeneic bone marrow transplantation, patients walk on a treadmill or in the hospital hallways twice daily for ≥ 15 minutes. After discharge and continuing for up to 100 days post-transplantation, patients walk once daily for ≥ 30 minutes. Patients record their walking times daily in a journal.
  • Arm II: Patients receive no special instructions regarding exercise other than the normal standard of care.

All patients complete questionnaires at discharge and at day 100 post-transplantation measuring daily exercise activities, satisfaction with the recommended walking regimen, and functional status.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following malignancies:

    • Acute lymphocytic leukemia
    • Chronic myelogenous leukemia
    • Acute myeloid leukemia
    • Hodgkin's lymphoma
    • Non-Hodgkin's lymphoma
    • Myelodysplastic syndromes
    • Other malignancy
  • Undergoing concurrent allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

  • Able to walk

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445731

Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Todd Defor, MS Masonic Cancer Center, University of Minnesota
  More Information

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

Study ID Numbers: CDR0000531905, UMN-2002NT039, UMN-2002LB039, UMN-BMT-MT2002-04S, UMN-0204M22681
Study First Received: March 7, 2007
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00445731  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
poor performance status
unspecified adult solid tumor, protocol specific
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)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
myelodysplastic/myeloproliferative disease, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Ovarian epithelial cancer
Lymphoma, large-cell, immunoblastic
Mycoses
Preleukemia
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Acute myelogenous leukemia
Myeloproliferative Disorders
Breast Neoplasms
Leukemia, Myeloid
Testicular Neoplasms
Multiple Myeloma

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

ClinicalTrials.gov processed this record on January 16, 2009