Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies
NCT ID: NCT01880996
Last Updated: 2015-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2014-08-31
2015-08-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tai-chi/Qi-gong
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
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
Usual Care
30 gynecological cancer patients scheduled for primary or secondary chemotherapy treatment, will be evaluated by the same measures as the intervention group.
No interventions assigned to this group
Interventions
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Tai-chi/Qi-gong
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Less than 1 month since the last abdominal surgery;
* Ascites
18 Years
FEMALE
No
Sponsors
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Tel Aviv University
OTHER
Sheba Medical Center
OTHER_GOV
Responsible Party
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Dorit Gamus
Director, Complementary Medicine Service
Principal Investigators
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Dorit Gamus, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba Hospital
Ramat Gan, , Israel
Countries
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References
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Oh B, Butow P, Mullan B, Clarke S, Beale P, Pavlakis N, Kothe E, Lam L, Rosenthal D. Impact of medical Qigong on quality of life, fatigue, mood and inflammation in cancer patients: a randomized controlled trial. Ann Oncol. 2010 Mar;21(3):608-614. doi: 10.1093/annonc/mdp479. Epub 2009 Oct 30.
Peppone LJ, Mustian KM, Janelsins MC, Palesh OG, Rosier RN, Piazza KM, Purnell JQ, Darling TV, Morrow GR. Effects of a structured weight-bearing exercise program on bone metabolism among breast cancer survivors: a feasibility trial. Clin Breast Cancer. 2010 Jun;10(3):224-9. doi: 10.3816/CBC.2010.n.030.
Yeh ML, Lee TI, Chen HH, Chao TY. The influences of Chan-Chuang qi-gong therapy on complete blood cell counts in breast cancer patients treated with chemotherapy. Cancer Nurs. 2006 Mar-Apr;29(2):149-55. doi: 10.1097/00002820-200603000-00012.
Padilla GV, Mishel MH, Grant MM. Uncertainty, appraisal and quality of life. Qual Life Res. 1992 Jun;1(3):155-65. doi: 10.1007/BF00635615.
Pud D, Ben Ami S, Cooper BA, Aouizerat BE, Cohen D, Radiano R, Naveh P, Nikkhou-Abeles R, Hagbi V, Kachta O, Yaffe A, Miaskowski C. The symptom experience of oncology outpatients has a different impact on quality-of-life outcomes. J Pain Symptom Manage. 2008 Feb;35(2):162-70. doi: 10.1016/j.jpainsymman.2007.03.010. Epub 2007 Dec 21.
Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.
Other Identifiers
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SHEBA-13-0112-DG-CTIL
Identifier Type: -
Identifier Source: org_study_id
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