Clinical trial NCT01880996: Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies
Official title: The Effect of Tai-chi/Qi-gong on Quality of Life (QOL), Sleep, and Fatigue in Patients With Gynecological Malignancies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Primary Peritoneal Cancer
Other Gynecological Cancers
Keywords: Ovarian Cancer
Gynecological Malignancies
Chemotherapy
Tai-chi
Qigong
Fatigue
Quality of life
Sleep disturbance
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2013-06-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA
timeFrame: Week 0, Week 5, Week 10
Secondary outcomes:
measure: Change in the Lee Fatigue Scale (LFS)
timeFrame: Week 0, Week 5, Week 10
measure: Change in the Visual Analog Scale for Pain
timeFrame: Week 0, Week 5, Week 10
Other outcomes:
measure: Change in the White Blood Cell Count
timeFrame: Week 0, Week 3, Week 6, Week 9
measure: Change in the Hemoglobin in blood
timeFrame: Week 0, Week 3, Week 6, Week 9
measure: Change in the C-reactive protein in blood
timeFrame: Week 0, Week 3, Week 6, Week 9
measure: Change in the Body Weight
timeFrame: Week 0, Week 5, Week 10
measure: Change in the number of Emergency Room visits
timeFrame: Week 0, Week 5, Week 10
measure: Pattern of use of Complementary Medicine
timeFrame: Week 0, Week 5, Week 10
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Hospital
Study officials:
affiliation: Sheba Medical Center
name: Dorit Gamus, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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):608-614. doi: 10.1093/annonc/mdp479. Epub 2009 Oct 30.
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.
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. doi: 10.1097/00002820-200603000-00012.
citation: 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.
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. doi: 10.1016/j.jpainsymman.2007.03.010. Epub 2007 Dec 21.
citation: 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.