Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors - Full Text View

Sponsors and Collaborators:	University of Utah National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00335491

Purpose

RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.

PURPOSE: This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.

Condition	Intervention
Bladder Cancer Breast Cancer Colorectal Cancer Esophageal Cancer Fatigue Lung Cancer Lymphoma Ovarian Cancer Prostate Cancer	Behavioral: exercise intervention Procedure: complementary or alternative medicine procedure Procedure: fatigue assessment and management Procedure: physical therapy

Genetics Home Reference related topics: bladder cancer breast cancer

MedlinePlus related topics: Bladder Cancer Breast Cancer Cancer Colorectal Cancer Esophageal Cancer Esophagus Disorders Exercise and Physical Fitness Lung Cancer Lymphoma Ovarian Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	A RENEW Intervention for Elderly Cancer Survivors

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

Estimated Enrollment:	40
Study Start Date:	March 2006
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the perception of, and the patterns of change in fatigue, weakness, physical activity level, and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work (RENEW) vs standard care.
Compare changes in muscle structure, function (strength + power production and metabolic function) and mobility.
Evaluate the patient's adherence to and satisfaction with the RENEW intervention.

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

Arm I: Patients undergo resistance exercise via negative-eccentric work (RENEW), using a special seated stationary leg exercise machine, 3 times a week for up to 12 weeks. Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW.
Arm II: Patients receive standard care. In both arms, fatigue, weakness, physical activity, functional status, muscle structure and function, and mobility are assessed at baseline and then at 12 weeks after completion of study intervention. Fatigue and weakness are also assessed weekly during study intervention. Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Survivor of breast, prostate, colon, lung, lymphoma, ovarian, bladder, or esophageal cancer with no evidence of disease
At least moderate levels of fatigue and/or weakness
Impaired mobility but ambulatory and medically able to participate in an exercise regimen
- No impaired knee flexion, defined as < 90º

PATIENT CHARACTERISTICS:

Folstein Mini-Mental Status Examination score ≥ 23
No extreme claustrophobia
No diagnosed chronic fatigue syndrome/disorder
No neurological impairments, including the following:
- Central nervous system disorder (e.g., multiple sclerosis or Parkinson's disease)
- Neurological insult (cerebrovascular attack) that manifests in a mobility disorder
No myopathic disease (e.g., focal myopathy) that effects skeletal muscle structure/function
No rheumatological disease that has an effect on muscle and/or mobility (e.g., polymyalgia rheumatica)

PRIOR CONCURRENT THERAPY:

More than 6 months since prior regular aerobic or resistance exercise
- Regular exercise defined as 2-3 times per week
At least 6 months since prior cancer treatment (surgery, radiation, and/or chemotherapy )
No concurrent cancer-related treatment other than hormonal therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335491

Locations

United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

University of Utah

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Paul C. LaStayo, PhD, PT

University of Utah

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000482338, UUMC-R21CA114523
Study First Received:	June 8, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00335491 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

small cell lung cancer
non-small cell lung cancer
colon cancer
prostate cancer
breast cancer
male breast cancer

fatigue
lymphoma
ovarian epithelial cancer
bladder cancer
esophageal cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Prostatic Diseases
Colonic Diseases
Urogenital Neoplasms
Breast Cancer, Male
Urologic Neoplasms
Rectal Diseases
Lung Neoplasms
Ovarian Cancer
Breast Diseases
Endocrine Gland Neoplasms
Digestive System Neoplasms
Immunoproliferative Disorders
Asthenia
Urinary Bladder Diseases

Urinary Bladder Neoplasms
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Esophageal Cancer
Genital Diseases, Male
Carcinoma, Small Cell
Breast Neoplasms, Male
Esophageal Disorder
Lung Diseases
Gastrointestinal Neoplasms
Esophageal Diseases
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Urinary Tract Neoplasm

Additional relevant MeSH terms:

Thoracic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Gonadal Disorders
Gastrointestinal Diseases
Esophageal Neoplasms
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Urologic Neoplasms
Rectal Diseases
Genital Diseases, Female
Signs and Symptoms
Neoplasms by Site
Respiratory Tract Diseases

Urologic Diseases
Lung Neoplasms
Lymphoma
Breast Diseases
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Ovarian Neoplasms
Fatigue
Digestive System Neoplasms
Immune System Diseases
Skin Diseases
Urinary Bladder Diseases
Genital Neoplasms, Female

ClinicalTrials.gov processed this record on May 06, 2009