Breast CancerNCT00495209
Pre-Surgical Qigong Therapy for Women With Breast Cancer
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Qigong
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2006to 7 Mar 2018
- Phase
- Observational
- 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
Study population: Women with breast cancer who are awaiting surgery.
Who may be able to join
- 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
- 18 years of age or older because the assessment tools are not validated for use in minors.
Who cannot join
- Women with lobular carcinoma
- Prior or planned neoadjuvant treatment with chemotherapy or radiotherapy
- Evidence of metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Some research has been done on the human body to learn about how it may exist within an electromagnetic (energy with electric and magnetic parts) field. Some research has shown that changing the form of this field may have an effect on cell growth.
You will be asked to complete 3 questionnaires that ask about your quality of life (QOL), your physical functioning, and any symptoms you may be having. The questionnaires will take about 15 to 20 minutes to complete. You will also have a physical exam. If you have had mammogram and ultrasound less than one week after your core biopsy, you will need to have a repeat mammogram and ultrasound to check the size of your tumor.
You will then be scheduled for a total of 5 EQT sessions (1 session per day for 5 consecutive days). You will meet with an expert in EQT (qigong master) to conduct the sessions. During each session, the qigong master will send forth qi (energy) focused toward helping to improve patients' physical and mental functioning. The qigong master will do this by placing his hands over the affected area and emitting his energy into your body. He will not touch you, but will say a few words. These comments will be spoken in Chinese and may be translated into English by a translator. The sessions may be conducted in a group setting. After each session, you will have a physical exam. Each session will last about 30 minutes.
Once you have completed all the sessions, you will have a follow-up visit. During this visit, you will have a physical exam and a mammogram and ultrasound to check the size of your tumor. You will also be asked to complete 3 more questionnaires that will ask the same questions as before. The questionnaires will take about 15 to 20 minutes to complete.
In order to find out if women are willing to have EQT, researchers will keep track of how many people are asked to join the study and how many decide to participate. If you consent to participate, the study staff will keep track of the EQT sessions you attend, if you complete the questionnaires, and if you provide the optional blood samples.
Your participation in this study will be over after your follow-up visit.
This is an investigational study. The baseline mammogram and ultrasound are standard of care. All questionnaires and the follow-up mammogram and ultrasound are for research purposes. Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson or Fudan University Cancer Hospital.
- Conditions
- Breast Cancer
- Being tested
- Qigong
- Keywords
- Complementary and Alternative Medicine, Breast Cancer, Qigong, Medical Qigong, External Qi Therapy, EQT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongOther
Also called Bioenergy Therapy, External Qi Therapy, EQT
EQT daily for 5 consecutive days prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Qigong | Pre-surgical Qigong therapy for women with breast cancer
External Qi Therapy = EQT Receives: Other: Qigong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting external qigong in women with breast cancer awaiting surgery
Measured: 3 Years
Secondary outcomes (1)
Initial efficacy of external qi therapy (EQT) as measured by tumor size
Measured: Baseline to end of treatment (5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study start26 Jul 2006
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495209
- Sponsor's protocol ID
- 2005-0876
- Status last verified
- Aug 2018
- First submitted
- 28 Jun 2007
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Surgical Qigong Therapy for Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00495209
- Acronym / sponsor ID
- 2005-0876
- Conditions
- Breast Cancer
- Keywords
- Complementary and Alternative Medicine, Breast Cancer, Qigong, Medical Qigong, External Qi Therapy, EQT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 26 Jul 2006 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Some research has been done on the human body to learn about how it may exist within an electromagnetic (energy with electric and magnetic parts) field. Some research has shown that changing the form of this field may have an effect on cell growth.
You will be asked to complete 3 questionnaires that ask about your quality of life (QOL), your physical functioning, and any symptoms you may be having. The questionnaires will take about 15 to 20 minutes to complete. You will also have a physical exam. If you have had mammogram and ultrasound less than one week after your core biopsy, you will need to have a repeat mammogram and ultrasound to check the size of your tumor.
You will then be scheduled for a total of 5 EQT sessions (1 session per day for 5 consecutive days). You will meet with an expert in EQT (qigong master) to conduct the sessions. During each session, the qigong master will send forth qi (energy) focused toward helping to improve patients' physical and mental functioning. The qigong master will do this by placing his hands over the affected area and emitting his energy into your body. He will not touch you, but will say a few words. These comments will be spoken in Chinese and may be translated into English by a translator. The sessions may be conducted in a group setting. After each session, you will have a physical exam. Each session will last about 30 minutes.
Once you have completed all the sessions, you will have a follow-up visit. During this visit, you will have a physical exam and a mammogram and ultrasound to check the size of your tumor. You will also be asked to complete 3 more questionnaires that will ask the same questions as before. The questionnaires will take about 15 to 20 minutes to complete.
In order to find out if women are willing to have EQT, researchers will keep track of how many people are asked to join the study and how many decide to participate. If you consent to participate, the study staff will keep track of the EQT sessions you attend, if you complete the questionnaires, and if you provide the optional blood samples.
Your participation in this study will be over after your follow-up visit.
This is an investigational study. The baseline mammogram and ultrasound are standard of care. All questionnaires and the follow-up mammogram and ultrasound are for research purposes. Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson or Fudan University Cancer Hospital.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qigong | – | Other: QigongPre-surgical Qigong therapy for women with breast cancer External Qi Therapy = EQT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer who are awaiting surgery.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Women with lobular carcinoma
- Prior or planned neoadjuvant treatment with chemotherapy or radiotherapy
- Evidence of metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QigongAlso: Bioenergy Therapy, External Qi Therapy, EQTEQT daily for 5 consecutive days prior to surgery. | Other | Qigong |
Primary outcome
Feasibility of conducting external qigong in women with breast cancer awaiting surgery
Time frame: 3 Years
1 secondary outcome
Initial efficacy of external qi therapy (EQT) as measured by tumor size
Time frame: Baseline to end of treatment (5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Cohen, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 15 Aug 2018. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of conducting external qigong in women with breast cancer awaiting surgery (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2018.