Protocol Number: 06-AT-0016

Title:

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

Number:

06-AT-0016

Summary:

This study will compare the effectiveness of Tai Chi (a sequence of slow, graceful body movements) and a cardiovascular exercise fitness program in improving physical fitness and endurance, reducing stress and improving well-being in adult survivors of cancer. Tai Chi, described by some as a moving form of yoga and meditation combined, evolved from martial arts and breathing exercises in China hundreds of years ago. This study uses the 24-posture standardized Tai Chi. The movements are continuous, smooth, and natural, with the upper and lower parts of the body following each other. The entire body is always in motion, with the movements performed gently and at a uniform speed. The exercise training program uses an exercise machine. The training regimen is adjusted to maintain the individual's average training heart rate at 70 to 80 percent heart rate reserve; i.e., 220 minus the person's age.

Cancer survivors of solid tumor cancers who are between 18 and 65 years of age, whose treatment included chemotherapy, biologic agents or vaccines, who have had no cancer treatment for at least 24 months, and who have had no evaluable disease within 3 months of screening for this study may be eligible to participate.

Participants are randomly assigned to one of three study groups: Tai Chi, exercise training, or a waiting list. Individuals in the Tai Chi and exercise training groups participate in a supervised program for 1 hour 3 times a week for 12 weeks in the NIH Clinical Center's Rehabilitation Medicine department. Individuals assigned to the waiting list are followed for 12 weeks during the waiting period and are then assigned to either the Tai Chi or exercise program for another 12 weeks as described above.

At three time points during the study-before starting the program and after 6 weeks and 12 weeks of practicing the study intervention or being on the waiting list-participants undergo the following procedures:

Complete questionnaires regarding their quality of life and stress

Rehabilitation medicine evaluation, including the following:

-Questions about managing their daily activities, whether their skills have changed over time, what they may or may not have been able to do, or what they may have had to overcome as a result of their previous illness and the study program they have been practicing

-Measurements of strength and mobility

-Evaluation of overall physical fitness and endurance

-Blood tests to measure blood cell counts and cholesterol, lipid, hormone and mineral levels

Sponsoring Institute:

National Center for Complementary and Alternative Medicine (NCCAM)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Mind-Body

Stress Reduction

Complementary Medicine

Quality of Life

Well-being

Recruitment Keyword(s):

Cancer Survivor

Stress Reduction

Condition(s):

Cancer

Cancer Survivor

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: Tai Chi Chuan

Supporting Site:

National Center for Complementary and Alternative Medicine

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Chernecky C. Temporal differences in coping, mood, and stress with chemotherapy.Cancer Nurs. 1999 Aug;22(4):266-76.

Hughes J. Emotional reactions to the diagnosis and treatment of early breast cancer. J Psychosom Res. 1982;26(2):277-83.

Sabbioni ME, Bovbjerg DH, Jacobsen PB, Manne SL, Redd WH. Treatment related psychological distress during adjuvant chemotherapy as a conditioned response. Ann Oncol. 1992 May;3(5):393-8.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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