|Phase II||Supportive care||Active||18 to 60||NCCAM||060016|
06-AT-0016, NCCAM-06-AT-0016, NCI-06-AT-0016, NCT00246818
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 60 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
Further Study Information
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:
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 - 60 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.
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.
Trial Lead Organizations/Sponsors
National Center for Complementary and Alternative Medicine
|Patient Recruitment and Public Liaison Office||Ph: (800) 411-1222|
|National Center for Complementary and Alternative Medicine|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00246818
Information obtained from ClinicalTrials.gov on 2006-11-21
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