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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Sheba Medical Center
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Dorit Gamus, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01880996
First received: May 30, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Other Gynecological Cancers
Other: Tai-chi/Qi-gong
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Tai-chi/Qi-gong on Quality of Life (QOL), Sleep, and Fatigue in Patients With Gynecological Malignancies

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA [ Time Frame: Week 0, Week 5, Week 10 ] [ Designated as safety issue: No ]
    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:
  • Change in the Lee Fatigue Scale (LFS) [ Time Frame: Week 0, Week 5, Week 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in the White Blood Cell Count [ Time Frame: Week 0, Week 3, Week 6, Week 9 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in the Body Weight [ Time Frame: Week 0, Week 5, Week 10 ] [ Designated as safety issue: No ]
  • Change in the number of Emergency Room visits [ Time Frame: Week 0, Week 5, Week 10 ] [ Designated as safety issue: No ]
    Emergency Room visits for nausea, vomiting, or dehydration

  • Pattern of use of Complementary Medicine [ Time Frame: Week 0, Week 5, Week 10 ] [ Designated as safety issue: No ]
    List of Complementary modalities used including Medical Cannabis


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
Other Names:
  • Tai Chi
  • Qi-gong
  • Taichi
  • Qigong
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880996

Contacts
Contact: Dorit Gamus, M.D. Ph.D. 97235303956 dorit.gamus@sheba.health.gov.il

Locations
Israel
Sheba Hospital Not yet recruiting
Ramat Gan, Israel
Contact: Dorit Gamus, M.D. Ph.D.    9725303956    dorit.gamus@sheba.health.gov.il   
Sub-Investigator: Jacob Korach, M.D.         
Sub-Investigator: Limor Helpman, M.D.         
Sub-Investigator: Mario Binder, M.D.         
Sub-Investigator: Ludmila Yermin, M.D.         
Sub-Investigator: Tamar Perl, M.D.         
Sub-Investigator: Nisim Tamira, M.D.         
Sub-Investigator: Shalom Firster, M.D.         
Sub-Investigator: Gilad Ben-Baruch, M.D.         
Sub-Investigator: Aliza Hakimian, M.D.         
Principal Investigator: Dorit Gamus, M.D. Ph.D.         
Sponsors and Collaborators
Sheba Medical Center
Tel Aviv University
Investigators
Principal Investigator: Dorit Gamus, M.D. Ph.D. Sheba Medical Center
  More Information

Publications:
Responsible Party: Dorit Gamus, Director, Complementary Medicine Service, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01880996     History of Changes
Other Study ID Numbers: SHEBA-13-0112-DG-CTIL
Study First Received: May 30, 2013
Last Updated: June 20, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Ovarian Cancer
Gynecological Malignancies
Chemotherapy
Tai-chi
Qigong
Fatigue
Quality of life
Sleep disturbance

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014