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A RENEW Intervention for Elderly Cancer Survivors


N/A
60 Years
N/A
Not Enrolling
Both
Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Fatigue, Lung Cancer, Lymphoma, Ovarian Cancer, Prostate Cancer

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Trial Information

A RENEW Intervention for Elderly Cancer Survivors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Patient perception and pattern of change

Outcome Description:

To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status

Outcome Time Frame:

3 months of training followed by 6 and 12 months of no formal training

Safety Issue:

Yes

Principal Investigator

Paul C. LaStayo, PhD, PT

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah

Authority:

United States: Federal Government

Study ID:

14551

NCT ID:

NCT00335491

Start Date:

March 2006

Completion Date:

March 2010

Related Keywords:

  • Bladder Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Fatigue
  • Lung Cancer
  • Lymphoma
  • Ovarian Cancer
  • Prostate Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Fatigue
  • Lung Neoplasms
  • Lymphoma
  • Ovarian Neoplasms
  • Prostatic Neoplasms

Name

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