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

June 10, 2015 updated by: Dorit Gamus, Sheba Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  • Qigong
  • Taichi
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA
Time Frame: 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).
Week 0, Week 5, Week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Lee Fatigue Scale (LFS)
Time Frame: 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).
Week 0, Week 5, Week 10
Change in the Visual Analog Scale for Pain
Time Frame: Week 0, Week 5, Week 10
Week 0, Week 5, Week 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the White Blood Cell Count
Time Frame: Week 0, Week 3, Week 6, Week 9
Results of the routine blood exams will be documented
Week 0, Week 3, Week 6, Week 9
Change in the Hemoglobin in blood
Time Frame: Week 0, Week 3, Week 6, Week 9
Results of the routine blood exams will be documented
Week 0, Week 3, Week 6, Week 9
Change in the C-reactive protein in blood
Time Frame: Week 0, Week 3, Week 6, Week 9
Week 0, Week 3, Week 6, Week 9
Change in the Body Weight
Time Frame: Week 0, Week 5, Week 10
Week 0, Week 5, Week 10
Change in the number of Emergency Room visits
Time Frame: Week 0, Week 5, Week 10
Emergency Room visits for nausea, vomiting, or dehydration
Week 0, Week 5, Week 10
Pattern of use of Complementary Medicine
Time Frame: Week 0, Week 5, Week 10
List of Complementary modalities used including Medical Cannabis
Week 0, Week 5, Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Tel Aviv University

Investigators

  • Principal Investigator: Dorit Gamus, M.D. Ph.D., Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-13-0112-DG-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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