Cancer Clinical Trial
Official 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
Verified date | February 25, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 76 |
Est. completion date | February 25, 2011 |
Est. primary completion date | July 31, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Center for Complementary and Integrative Health (NCCIH) |
United States,
Chernecky C. Temporal differences in coping, mood, and stress with chemotherapy. Cancer Nurs. 1999 Aug;22(4):266-76. — View Citation
Hughes J. Emotional reactions to the diagnosis and treatment of early breast cancer. J Psychosom Res. 1982;26(2):277-83. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|