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A Randomized Study of the Effect of Tai Chi Chuan Compared to a Structured Exercise Program on Parameters of Physical Fitness and Stress in Adult Cancer Survivors


Phase 2
18 Years
65 Years
Not Enrolling
Both
Cancer, Cancer Survivor

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Trial Information

A Randomized Study of the Effect of Tai Chi Chuan Compared to a Structured Exercise Program on Parameters of Physical Fitness and Stress in Adult Cancer Survivors


Diagnosis and treatment for cancer represent a major life-time stressor for any patient.
While the diagnosis of a life-threatening illness is stressful, undergoing treatment for
cancer including surgery, radiotherapy and chemotherapy result in stress to the patient. In
addition, cancer treatment frequently is associated with fatigue, physical de-conditioning
and metabolic abnormalities characteristic of the metabolic syndrome, leading to
speculations that cancer therapy may render survivors more prone to developing metabolic
syndrome and its sequelae, cardiovascular disease. In a recently conducted study we detected
a high incidence of hyperlipidemia and increased body fat content, decreased aerobic
performance and musculoskeletal functioning and a high frequency of parameters of
psychological distress in long-term survivors of pediatric sarcoma. Based on these data and
findings, it appears desirable to devise a program that would help cancer survivors not only
to improve musculoskeletal functioning and aerobic performance, as a physical exercise
program would offer, but in addition relieve psychological stress and enhance the well-being
of cancer survivors after completion of treatment with multimodality therapy. Tai Chi Chuan
(TCC) has been used in Asian culture for centuries to improve wellness, reduce stress, and
to promote healing by improving the flow of Qi. While a number of studies have provided
scientific support for these claims in different populations, a beneficial role for TCC in
the management of cancer survivors has not been established.

This study aims to compare in a randomized, wait-list controlled design, the efficacy of TCC
to an exercise program in improving aerobic exercise capacity and endurance, reducing stress
and improving Quality of Life in adult survivors of malignant solid tumors.

Inclusion Criteria


- INCLUSION CRITERIA:

To be eligible for this study, patients must meet the following criteria:

Diagnosis of solid cancer

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1

Age 18 - 65 years at time of study enrollment

Patients must be considered cancer survivors defined either as:

In the first continued remission from cancer after completion of initial therapy (i.e., No
Evaluable Disease (NED) for greater than 2 years after successful completion of initial
cancer therapy) or

In continued remission for greater than 5 years after completion of salvage therapy for
disease recurrence

Must have completed cancer treatment regimen that includes chemotherapy, biologic agents
(e.g. IL-2, interferon) or vaccines

Patients must have had no cancer treatment (e.g., chemotherapy, radiation therapy, cancer
related surgery and/or immunotherapy) within the last 24 months

Patients must be free of recurrence at the time of evaluation (e.g., No Evaluable Disease
(NED) by history and evaluation within the past 3 months)

Must be able to understand and sign consent.

EXCLUSION CRITERIA:

Diagnosis of hematologic malignancy

History of CAD/Angina or cardiomyopathy

History of CVA/stroke

Current clinical diagnosis of major depression

Prior or current practice of Tai Chi Chuan

Inability to perform and follow study intervention routine or study assessments/measures
according to assessment of Principal Investigator, Rehabilitation Medicine Physician or
TCC instructor (Dr. Adeline Ge).

Treatment with stimulants, antidepressants (for diagnosis of major depression),
neuroleptics, betablockers or cardiac antiarrhythmics.

Current enrollment on or participation in a regular, structured exercise program.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

In adult solid cancer survivors, to determine that the TCC arm will have a larger reduction in psychological stress measured by the Perceived Stress Scale compared to the aerobic exercise and wait-list arms.

Authority:

United States: Federal Government

Study ID:

060016

NCT ID:

NCT00246818

Start Date:

October 2005

Completion Date:

February 2011

Related Keywords:

  • Cancer
  • Cancer Survivor
  • Mind-Body
  • Stress Reduction
  • Complementary Medicine
  • Quality of Life
  • Well-being
  • Psychoneuroimmunology
  • Tai Chi
  • Aerobic Exercise
  • Cancer Survivor

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892