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Ovarian CancerPhase 1/2NCT01880996

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

A Phase 1/2 study testing Tai-chi/Qi-gong in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Sheba Medical Center at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Tai-chi/Qi-gong
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteIsrael
Study dates
Aug 2014to Aug 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women with gynecological malignancies undergoing primary or secondary chemotherapy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Sheba Hospital

    Ramat Gan

Other trials in Israel

About this study

Official title: 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.

Read the 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).

Being tested
Tai-chi/Qi-gong
Keywords
Ovarian Cancer, Gynecological Malignancies, Chemotherapy, Tai-chi, Qigong, Fatigue, Quality of life, Sleep disturbance
Medical subject headings
Ovarian Neoplasms, Fatigue, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai-chi/Qi-gongOther

    Also called Tai Chi, Qi-gong, Taichi, Qigong

    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

Study groups in NCT01880996
Study groupRoleWhat they receive
Tai-chi/Qi-gongExperimental30 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.
Receives: Other: Tai-chi/Qi-gong
Usual CareNo intervention30 gynecological cancer patients scheduled for primary or secondary chemotherapy treatment, will be evaluated by the same measures as the intervention group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 0, Week 5, Week 10

Secondary outcomes (2)

  1. 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).

    Measured: Week 0, Week 5, Week 10

  2. Change in the Visual Analog Scale for Pain

    Measured: Week 0, Week 5, Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2013 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2015 (estimated)
  4. Study completionAug 2015 (estimated)

Why it stopped: The deparment failed to detect patients that were willing to participate in this study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01880996
Sponsor's protocol ID
SHEBA-13-0112-DG-CTIL
Status last verified
Jun 2015
First submitted
30 May 2013
Last updated
11 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19880433

  • 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.

    PubMed 20497921

  • 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.

    PubMed 16565626

  • 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.

    PubMed 1301125

  • 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.

    PubMed 18082357

  • 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.

    PubMed 2062970

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tai-chi/Qi-gong in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Sheba Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA (time frame: Week 0, Week 5, Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01880996, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.

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