Breast CancerENERGYNCT01112839
Reducing Breast Cancer Recurrence With Weight Loss
A study testing Less Intensive and Intensive Group in people with Breast Cancer and Overweight, run by University of California, San Diego at 4 sites in United States.
Trial summary
The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Overweight, Obesity
- What is being tested?
- Less Intensive and Intensive Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2010to Feb 2015
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
- BMI between 25 to 45 kg/m2
- Able to comply with all required study procedures and schedule
Who cannot join
- Serious medical condition or psychiatric illness
- Inability to be moderately physically active
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)
- Currently enrolled in a weight loss program
- Current use of weight loss medication or supplements
- Previous surgical procedures for weight reduction
Show all 14Show fewer
- Planning weight loss surgery in the next 2 years.
- 6+ months use of meds likely to cause weight gain or prevent weight loss
- Planned surgical procedure that can impact the conduct of the study
- Currently pregnant/breastfeeding
- Planning to become pregnant within the next 2 years
- Have plans to relocate from area within 2 years
- Family relative or close friend is a trial staff member or a study participant
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3360
Moores UCSD Cancer Center
La Jolla, California, 92093
Washington University in St. Louis:
St Louis, Missouri, 63110
About this study
Official title: Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.
- Conditions
- Breast Cancer, Overweight, Obesity
- Being tested
- Less Intensive, Intensive Group
- Keywords
- Overweight, Obese, Breast cancer survivors, Weight loss, Exercise, Physical activity
- Medical subject headings
- Breast Neoplasms, Overweight, Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Less IntensiveBehavioural
Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.
Intensive GroupBehavioural
Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
| Study group | Role | What they receive |
|---|---|---|
| Less Intensive Group | Active comparator | Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later. Receives: Behavioral: Less Intensive |
| Intensive Group | Experimental | Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year. Receives: Behavioral: Intensive Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 2 years
Secondary outcomes (2)
Improvement in quality of life
Measured: 2 years
Improvement in fatigue
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, University of Colorado, Denver, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Cheryl Rock, University of California, San Diego
- Investigators
- Cheryl L. Rock, PhD, RD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112839
- Sponsor's protocol ID
- CA148791-01
- Acronym
- ENERGY
- Status last verified
- Jun 2015
- First submitted
- 26 Apr 2010
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kenzik KM, Demark-Wahnefried W, Ganz PA, Colditz G, Rock CL, Rogers LQ. Changes in Body Mass Index and Physical Activity Predict Changes in Vitality During a Weight Loss Trial in Breast Cancer Survivors. Ann Behav Med. 2018 Nov 12;52(12):999-1009. doi: 10.1093/abm/kay004.
PubMed 29617707Rock CL, Flatt SW, Byers TE, Colditz GA, Demark-Wahnefried W, Ganz PA, Wolin KY, Elias A, Krontiras H, Liu J, Naughton M, Pakiz B, Parker BA, Sedjo RL, Wyatt H. Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors. J Clin Oncol. 2015 Oct 1;33(28):3169-76. doi: 10.1200/JCO.2015.61.1095. Epub 2015 Aug 17.
PubMed 26282657
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
- ClinicalTrials.gov ID
- NCT01112839
- Acronym / sponsor ID
- ENERGY / CA148791-01
- Conditions
- Breast Cancer, Overweight, Obesity
- Keywords
- Overweight, Obese, Breast cancer survivors, Weight loss, Exercise, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, University of Colorado, Denver, University of Alabama at Birmingham
- Study start
- May 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Apr 2010 (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 purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less Intensive Group | Active comparator | Behavioral: Less IntensiveParticipants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later. |
| Intensive Group | Experimental | Behavioral: Intensive GroupParticipants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
- BMI between 25 to 45 kg/m2
- Able to comply with all required study procedures and schedule
Key exclusion criteria (14 listed)
- Serious medical condition or psychiatric illness
- Inability to be moderately physically active
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)
- Currently enrolled in a weight loss program
- Current use of weight loss medication or supplements
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 |
|---|---|---|
| Less IntensiveParticipants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later. | Behavioural | Less Intensive Group |
| Intensive GroupParticipants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year. | Behavioural | Intensive Group |
Primary outcome
Weight loss
Time frame: 2 years
2 secondary outcomes
Improvement in quality of life
Time frame: 2 years
Improvement in fatigue
Time frame: 2 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 18 Jun 2015.
- Derived from this study: PubMed 29617707Kenzik KM, Demark-Wahnefried W, Ganz PA, Colditz G, Rock CL, Rogers LQ. Changes in Body Mass Index and Physical Activity Predict Changes in Vitality During a Weight Loss Trial in Breast Cancer Survivors. Ann Behav Med. 2018 Nov 12;52(12):999-1009. doi: 10.1093/abm/kay004.
- Derived from this study: PubMed 26282657Rock CL, Flatt SW, Byers TE, Colditz GA, Demark-Wahnefried W, Ganz PA, Wolin KY, Elias A, Krontiras H, Liu J, Naughton M, Pakiz B, Parker BA, Sedjo RL, Wyatt H. Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors. J Clin Oncol. 2015 Oct 1;33(28):3169-76. doi: 10.1200/JCO.2015.61.1095. Epub 2015 Aug 17.
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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.
Cheryl L. Rock, PhD, RD principal investigator
University of California, San Diego
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Less Intensive and Intensive Group in people with Breast Cancer and Overweight, run by University of California, San Diego at 4 sites 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 3 inclusion and 14 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 18 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 4 sites 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: 2 years). 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 NCT01112839, which also lists 2 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 18 Jun 2015.