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

Phase 1

Withdrawn

• Conditions: Ovarian Cancer; Primary Peritoneal Cancer; Other Gynecological Cancers
• Interventions: Other: Tai-chi/Qi-gong

• Registration Number: NCT01880996
• Lead Sponsor: Sheba Medical Center

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-19
• Study Start: 2014-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-11
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women with gynecological malignancies undergoing primary or secondary chemotherapy

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Exclusion Criteria

• Motor disability;
• Less than 1 month since the last abdominal surgery;
• Ascites

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai-chi/Qi-gong	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.

Primary Outcome Measures

Name	Time	Method
Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA	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).

Secondary Outcome Measures

Name	Time	Method
Change in the Visual Analog Scale for Pain	Week 0, Week 5, Week 10
Change in the Lee Fatigue Scale (LFS)	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).

Trial Locations

Locations (1)

Sheba Hospital; 🇮🇱 Ramat Gan, Israel