Breast CancerNCT02081612
Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy
A study testing Nutrition Education and Acupuncture in people with Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy. 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?
- Nutrition Education and Acupuncture
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 1 Dec 2018
- Phase
- Interventional
- 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
- Woman with a diagnosis of breast cancer, stage I, II, or III
- Age ≥ 18
- ECOG performance status ≤ 1
- Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
- BMI ≥ 30
- Adequate bone marrow and organ function as determined by the consenting/enrolling investigator
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- Signed informed consent
- Any receptor status
- Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
Who cannot join
- Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment.
- Diagnosis of metastatic breast cancer
- Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.)
- Current use of commercial or natural/herbal weight loss supplements
- Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
- Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- Personal history of an eating disorder
- Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled HIV, Hepatitis B or C), or any psychiatric disorder that prohibits obtaining informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Comparison of Weight Loss Among Early Stage Breast Cancer Patients Post Chemotherapy: Nutrition Education in Combination With Weight Loss Acupuncture Vs. Nutrition Education Alone
This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.
Read the detailed description
Obesity and weight gain are significant concerns for breast cancer survivors. Given the adverse consequences of weight gain after diagnosis, continued efforts to identify appropriate weight management interventions aimed at promoting overall health and long term survivorship are needed. In this study, the investigators will examine whether adding acupuncture to a nutrition education program for weight loss could improve short and long term weight loss among breast cancer survivors post treatment with chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Nutrition Education, Acupuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
12 educational weight management group session each addressing a different weight loss topic
AcupunctureProcedure or surgery
12 weight loss acupuncture session using both body and auricular points.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education | Active comparator | Educational weight management group sessions alone Receives: Behavioral: Nutrition Education |
| Nutrition Education Plus Acupuncture | Active comparator | Educational weight management group sessions in addition to weight loss acupuncture Receives: Behavioral: Nutrition Education; Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 24 weeks
Secondary outcomes (2)
Maintenance of weight loss
Measured: 24 months
Recurrence of breast cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startSep 2014
- Primary completion6 Mar 2018
- Study completion1 Dec 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 Icahn School of Medicine at Mount SinaiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Tiersten, Icahn School of Medicine at Mount Sinai
- Investigators
- Amy Tiersten, MD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081612
- Sponsor's protocol ID
- GCO 14-0001
- Status last verified
- Jul 2019
- First submitted
- 5 Mar 2014
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Weight Loss Among Early Stage Breast Cancer Patients Post Chemotherapy: Nutrition Education in Combination With Weight Loss Acupuncture Vs. Nutrition Education Alone
- ClinicalTrials.gov ID
- NCT02081612
- Acronym / sponsor ID
- GCO 14-0001
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 7 Mar 2014 (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.
This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.
Detailed description
Obesity and weight gain are significant concerns for breast cancer survivors. Given the adverse consequences of weight gain after diagnosis, continued efforts to identify appropriate weight management interventions aimed at promoting overall health and long term survivorship are needed. In this study, the investigators will examine whether adding acupuncture to a nutrition education program for weight loss could improve short and long term weight loss among breast cancer survivors post treatment with chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education | Active comparator | Behavioral: Nutrition EducationEducational weight management group sessions alone |
| Nutrition Education Plus Acupuncture | Active comparator | Behavioral: Nutrition Education, Procedure: AcupunctureEducational weight management group sessions in addition to weight loss acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Woman with a diagnosis of breast cancer, stage I, II, or III
- Age ≥ 18
- ECOG performance status ≤ 1
- Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
- BMI ≥ 30
Key exclusion criteria (8 listed)
- Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment.
- Diagnosis of metastatic breast cancer
- Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.)
- Current use of commercial or natural/herbal weight loss supplements
- Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
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 |
|---|---|---|
| Nutrition Education12 educational weight management group session each addressing a different weight loss topic | Behavioural | Nutrition Education, Nutrition Education Plus Acupuncture |
| Acupuncture12 weight loss acupuncture session using both body and auricular points. | Procedure or surgery | Nutrition Education Plus Acupuncture |
Primary outcome
Weight Loss
Time frame: 24 weeks
2 secondary outcomes
Maintenance of weight loss
Time frame: 24 months
Recurrence of breast cancer
Time frame: 5 years
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 19 Jul 2019.
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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.
Amy Tiersten, MD study director
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education and Acupuncture in people with Breast Cancer, run by Icahn School of Medicine at Mount Sinai 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 9 inclusion and 8 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 19 Jul 2019. 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?
Weight Loss (time frame: 24 weeks). 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 19 Jul 2019.