Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies

Ovarian Cancer Clinical Trial

Official title:

The Effect of Tai-chi/Qi-gong on Quality of Life (QOL), Sleep, and Fatigue in Patients With Gynecological Malignancies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01880996
• Other study ID #: SHEBA-13-0112-DG-CTIL
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 30, 2013
• Last updated: June 10, 2015
• Start date: August 2014
• Est. completion date: August 2015

Study information

• Verified date: June 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with gynecological malignancies undergoing primary or secondary chemotherapy

Exclusion Criteria:

• Motor disability;

• Less than 1 month since the last abdominal surgery;

• Ascites

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Other Gynecological Cancers
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
Israel	Sheba Hospital	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. — View Citation

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):608-14. doi: 10.1093/annonc/mdp479. Epub 2009 Oct 30. — View Citation

Padilla GV, Mishel MH, Grant MM. Uncertainty, appraisal and quality of life. Qual Life Res. 1992 Jun;1(3):155-65. — View Citation

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. — View Citation

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. Epub 2007 Dec 21. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the White Blood Cell Count	Results of the routine blood exams will be documented	Week 0, Week 3, Week 6, Week 9	No
Other	Change in the Hemoglobin in blood	Results of the routine blood exams will be documented	Week 0, Week 3, Week 6, Week 9	No
Other	Change in the C-reactive protein in blood		Week 0, Week 3, Week 6, Week 9	No
Other	Change in the Body Weight		Week 0, Week 5, Week 10	No
Other	Change in the number of Emergency Room visits	Emergency Room visits for nausea, vomiting, or dehydration	Week 0, Week 5, Week 10	No
Other	Pattern of use of Complementary Medicine	List of Complementary modalities used including Medical Cannabis	Week 0, Week 5, Week 10	No
Primary	Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA	The Multidimensional Quality of Life Scale cancer MQOLS-CA was written by Padilla (5) and translated into Hebrew by Dorit Pud (6).	Week 0, Week 5, Week 10	No
Secondary	Change in the Lee Fatigue Scale (LFS)	The Lee Fatigue Scale (LFS). The questionnaire was compiled by Lee (7) and translated into Hebrew by Dr. Dorit Pud (6).	Week 0, Week 5, Week 10	No
Secondary	Change in the Visual Analog Scale for Pain		Week 0, Week 5, Week 10	No