NCT00495209

Brief Summary

The use of complementary and alternative medicine (CAM) in the United States has increased dramatically in the past 10 years. Nowhere is this trend more apparent than when one examines CAM use by patients diagnosed with cancer. As with the general population, patients with cancer typically use CAM-based modalities alongside their conventional cancer treatments. Patients are often seeking a holistic approach to managing and preventing disease. Although most patients will combine alternative approaches with conventional medicine, some patients do in fact decline curative conventional treatments in favor of more non-toxic alternative approaches. One such approach that patients combine with conventional medicine or use in place of conventional medicine is qigong. Qigong is a bioenergy therapy with a long history of therapeutic use for many diseases, including cancer. Preliminary experiments and a review of the literature show that qigong might improve the outcome for cancer patients. However, none of this research has been confirmed in the peer-reviewed Western scientific literature. Although it is unlikely that EQT will result in significant decreases in tumor size, patients are using qigong either as a complementary approach, and sometimes even in place of conventional medicine, it is, therefore, important for us to determine whether there is any merit to this treatment modality. The goal of this pilot trial is to examine one form of medical qigong (external qi therapy (EQT)) to determine feasibility. In an exploratory nature we will also examine any changes in tumor size in women with breast cancer who are awaiting surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

11.6 years

First QC Date

June 28, 2007

Last Update Submit

August 14, 2018

Conditions

Keywords

Complementary and Alternative MedicineBreast CancerQigongMedical QigongExternal Qi TherapyEQT

Outcome Measures

Primary Outcomes (1)

  • Feasibility of conducting external qigong in women with breast cancer awaiting surgery

    3 Years

Secondary Outcomes (1)

  • Initial efficacy of external qi therapy (EQT) as measured by tumor size

    Baseline to end of treatment (5 days)

Study Arms (1)

Qigong

Pre-surgical Qigong therapy for women with breast cancer External Qi Therapy = EQT

Other: Qigong

Interventions

QigongOTHER

EQT daily for 5 consecutive days prior to surgery.

Also known as: Bioenergy Therapy, External Qi Therapy, EQT
Qigong

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with breast cancer who are awaiting surgery.

You may qualify if:

  • Histologically confirmed and intact invasive ductal carcinoma
  • Women with a single measurable mass less than or equal to 3 cm
  • Women who are awaiting the surgical removal of breast cancer
  • Surgery is scheduled at least 2 weeks from the time of recruitment
  • Willing to come to MDACC or Fudan University Cancer Hospital (FUCH) for 5 consecutive days to receive the EQT
  • years of age or older because the assessment tools are not validated for use in minors.

You may not qualify if:

  • Women with lobular carcinoma
  • Prior or planned neoadjuvant treatment with chemotherapy or radiotherapy
  • Evidence of metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Qigong

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Lorenzo Cohen, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2007

First Posted

July 2, 2007

Study Start

July 26, 2006

Primary Completion

March 7, 2018

Study Completion

March 7, 2018

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations