Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies
|ClinicalTrials.gov Identifier: NCT01880996|
Recruitment Status : Withdrawn (The deparment failed to detect patients that were willing to participate in this study)
First Posted : June 19, 2013
Last Update Posted : June 11, 2015
Oncologic patients often report increased fatigue during and after chemotherapy. Evidence suggests Tai-chi/Qi-gong may improve quality of life (QOL) in oncologic patients treated with chemotherapy. Previous studies, mostly performed in a population of breast cancer patients, have demonstrated the benefits of Tai-chi/Qi-gong practice in improving quality of life (1), reducing bone resorption (2), preventing the decrease of blood counts (WBC and Hb) (3), and reducing inflammation (4).
The aim of this pilot study is to evaluate the effect of Tai-chi/Qi-gong on QOL, sleep, and fatigue in patients with gynecological malignancies, particularly in patients with ovarian cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Cancer Other Gynecological Cancers||Other: Tai-chi/Qi-gong||Phase 1 Phase 2|
Tai-chi/Qi-gong is a complementary medicine technique that synergizes the mind-body connection. The technique employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion.
The effect of Tai-chi/Qi-gong on fatigue, quality of life, and quality of sleep will be assessed in gynecological cancer patients. This trial will recruit 60 patients with gynecological malignancies, who receive first or second line chemotherapy. The patients will be allocated according to their preference to either the study or the control group. The Tai-chi/Qi-gong classes will take place once a week, for 10 consecutive weeks, at the facilities of the gyneco-oncology department. All patients will fill out the questionnaires at the beginning of the study, after 5 weeks, and upon the completion of the study (10 weeks).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Tai-chi/Qi-gong on Quality of Life (QOL), Sleep, and Fatigue in Patients With Gynecological Malignancies|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2015|
30 gynecological cancer patients scheduled for the first or second line of chemotherapy treatment will be recruited for this study to receive Tai-chi/qigong treatment initiated at the beginning of chemotherapy therapy, once a week (45 min each), for 10 weeks.
Tai-chi/Qi-gong employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion. The treatments will take place once a week at the Dept. of the Gyneco-oncology and the patients will be instructed to practice tai-chi at home on a daily basis
No Intervention: Usual Care
30 gynecological cancer patients scheduled for primary or secondary chemotherapy treatment, will be evaluated by the same measures as the intervention group.
- Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA [ Time Frame: Week 0, Week 5, Week 10 ]The Multidimensional Quality of Life Scale cancer MQOLS-CA was written by Padilla (5) and translated into Hebrew by Dorit Pud (6).
- Change in the Lee Fatigue Scale (LFS) [ Time Frame: Week 0, Week 5, Week 10 ]The Lee Fatigue Scale (LFS). The questionnaire was compiled by Lee (7) and translated into Hebrew by Dr. Dorit Pud (6).
- Change in the Visual Analog Scale for Pain [ Time Frame: Week 0, Week 5, Week 10 ]
- Change in the White Blood Cell Count [ Time Frame: Week 0, Week 3, Week 6, Week 9 ]Results of the routine blood exams will be documented
- Change in the Hemoglobin in blood [ Time Frame: Week 0, Week 3, Week 6, Week 9 ]Results of the routine blood exams will be documented
- Change in the C-reactive protein in blood [ Time Frame: Week 0, Week 3, Week 6, Week 9 ]
- Change in the Body Weight [ Time Frame: Week 0, Week 5, Week 10 ]
- Change in the number of Emergency Room visits [ Time Frame: Week 0, Week 5, Week 10 ]Emergency Room visits for nausea, vomiting, or dehydration
- Pattern of use of Complementary Medicine [ Time Frame: Week 0, Week 5, Week 10 ]List of Complementary modalities used including Medical Cannabis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880996
|Ramat Gan, Israel|
|Principal Investigator:||Dorit Gamus, M.D. Ph.D.||Sheba Medical Center|