Early Stage Breast CancerNCT01871116
POWER-remote Weight Loss Program in Early Stage Breast Cancer
A study testing POWER-remote and Self-directed in people with Early Stage Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This research is being done to assess the effectiveness of a weight loss program in women with early stage breast cancer whose body mass index (BMI) is in the overweight or obese range (>25). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- POWER-remote and Self-directed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2016
- 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
- Women
- 18 years or older
- Ductal carcinoma in situ (DCIS) or stage I-III invasive breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs, and willing to lose >5% of their body weight. NOTE: Participants may not have documented weight loss greater than 5% of body weight from time of diagnosis. Exceptions that are felt to be due to surgical or other procedures (e.g., mastectomies or reconstruction) may be allowed with prior approval of the Protocol Chair/designee.
- Patients must have completed local therapy (i.e. surgery and radiation therapy), and any preoperative or adjuvant chemotherapy within >3 and <60 months of registration. NOTE: Concurrent anti-HER2 therapy is permitted. Concurrent endocrine breast cancer therapy is permitted; patients may enroll >3 months after initiation of hormone therapy if expected to continue the same hormone agent for at least the first 6 months of the study. Concurrent enrollment in other interventional or drug clinical trials is at the discretion of the Protocol Chair.
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- Willingness to change diet, physical activity and weight.
- To ensure compliance with the POWER-remote and PatientViewpoint programs, patients must meet the following: prior experience with web forms and feels able to use the POWER-remote web program and PatientViewpoint; has or is able to download Internet Explorer 8+, Firefox 3.0+, Safari 4.0+, Chrome 4.0+, and Adobe Flash Player 10; familiarity with and access to internet at least 4 days per week; use of an email program or willing and able to establish one for this study; and, able to read and write the English language without assistance.
- Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Who cannot join
- History of another prior cancer within the last 5 years, with the exception of another breast cancer, adequately treated cone-biopsied in situ carcinoma of the cervix uteri, and basal or squamous cell carcinoma of the skin
- Medical condition likely to hinder accurate measurement of weight, including any condition: for which weight loss is contraindicated, which would likely cause weight loss, or which would affect adipokine and inflammatory markers (e.g., end stage renal disease (ESRD) on dialysis, cirrhosis, autoimmune disease, adrenal disease, and history of bariatric surgery).
- The use of the following medications are excluded: insulin or sulfonylureas; patients with thyroid disease who are not on stable doses of thyroid medication for at least the past 6 months; medications that cause weight loss (e.g., topiramate, bupropion, exenatide, lorcaserin, phentermine or orlistat) within the past 3 months; medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months; medications that may affect adipokine or inflammatory markers (e.g., sulfonylureas, glitazones, insulin, steroids, ACE inhibitors, beta blockers and statins) unless started ≥3 months prior to enrollment, or chronic NSAIDS (defined as use of ≥3 times a week) for ≥1 month.
- Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
- Currently enrolled or planning to enroll in a weight loss program (e.g., Innergy, Weight Watchers, Jenny Craig, Nutrisystem, and Medifast).
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-0013
About this study
Official title: A Randomized Study Evaluating the Effect of a Remote-Based Weight Loss Program (POWER-remote) on Biomarkers in Women With Early Stage Breast Cancer
This research is being done to assess the effectiveness of a weight loss program in women with early stage breast cancer whose body mass index (BMI) is in the overweight or obese range (>25). Weight loss is beneficial in improving cardiovascular risk factors and overall health, but may also decrease the chance of breast cancer coming back. A weight loss counseling program was studied in a general population and was found to be effective to help reduce weight over a 2 year period.
The main goal of this study is to determine if women with a recent diagnosis of early breast cancer will also lose weight with this program. To better understand the effect that weight loss has on women with breast cancer, we will compare the patterns in blood and breast tissue samples (tissue biopsies will be optional), and questionnaires evaluating different aspects of one's well-being, before and after a dietary intervention or no intervention.
Read the detailed description
The prevalence of obesity has increased rapidly in recent years. Epidemiological studies since the 1970's have strongly suggested that excess body weight gain may be a major risk factor for many cancers including breast cancer. In addition, once diagnosed with breast cancer, women who are overweight or obese experience worse outcomes despite standard local and adjuvant therapy. Furthermore, most women gain weight following a diagnosis of breast cancer, and this weight gain may increase risk of recurrence by 40-50% and breast cancer-related mortality by 53-60%.
A great deal of effort has been made for many years to explain the relationship between obesity and breast cancer. Molecularly, the relationship involves dynamic and complex interactions between a milieu of hormones, cytokines, adipokines, affecting cell signaling and potentially epigenetic pathways. Recently, studies in postmenopausal women have shown that weight loss modulates these cytokines and adipokines favorably. Inflammation associated with obesity can also be characterized pathologically when macrophages surround necrotic adipocytes in what are called crown-like structures (CLS). Furthermore, increased central obesity as measured by waist-to-hip ratios, may be associated with hypermethylation of certain breast cancer genes, and physical activity can reduce methylation of certain breast cancer-associated genes.
The Women's Intervention Nutrition Study (WINS) demonstrated that women with early-stage breast cancer receiving conventional cancer management randomized to a dietary intervention group had lower risk of relapse compared to those in a control group in those who lost weight. While women with a diagnosis of breast cancer are therefore recommended to maintain ideal body weight, limited progress has been made in developing feasible weight loss programs. However, collaborators from the Welch Center for Prevention, Epidemiology, and Clinical Research at the Johns Hopkins University have recently reported impressive and sustained weight loss in randomized controlled trials designated Practice-based Opportunities for Weight Reduction (POWER) in obese women with at least one cardiovascular risk factor using a remote-support weight loss intervention.
The overall goal of this study is to determine the effectiveness of the remote-support weight loss intervention of the POWER study, designated POWER-remote, in women with early breast cancer who are overweight or obese, and to assess the effects of weight loss of ≥5% body weight at 6 months and on biomarkers associated with obesity, inflammation, and breast cancer. The data will be used to implement a clinical intervention available to all overweight and obese women with breast cancer, and to design definitive studies assessing the impact of weight loss and biomarker modulation on risk of recurrent disease or development of new primary breast cancers.
- Conditions
- Early Stage Breast Cancer
- Being tested
- POWER-remote, Self-directed
- Keywords
- breast cancer, early stage, weight loss
- Medical subject headings
- Breast Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWER-remoteBehavioural
Web-based weight loss program.
Self-directedBehavioural
Pamphlet entitled "Aim for a Healthy Weight" will be given.
| Study group | Role | What they receive |
|---|---|---|
| POWER-remote | Experimental | Participants will start a weight loss program called POWER-remote for Breast Cancer Survivors. This program involves two main components: an online portion accessed on a computer through the internet and a telephone portion to help monitor progress. Receives: Behavioral: POWER-remote |
| Self-directed | Active comparator | Participants will receive a pamphlet entitled "Aim for a Healthy Weight", to help guide weight loss goals without access to the web-based POWER-remote system and coach support. Receives: Behavioral: Self-directed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
To compare the proportion of women with early stage breast cancer, who have completed all local therapy and adjuvant chemotherapy, who lose ≥5% of their baseline body weight after 6 and 12 months between a control arm (self-directed weight loss) and an experimental arm (POWER-remote)
Measured: After 12 months
Secondary outcomes (2)
Change in biomarkers
To evaluate the effects of weight loss and POWER-remote on serum biomarkers (including fasting glucose, fasting lipids, fasting insulin, insulin like growth factor (IGF), high-sensitivity C-reactive protein (hsCRP), interleukin 1 and 6 (IL-1 and IL-6), tumor necrosis factor- alpha (TNF-α), leptin, adiponectin, and estradiol) at baseline and 6 months
Measured: After 12 months
Change in PROs (Patient Reported Outcomes)
To evaluate the effects of weight loss and POWER-remote on PROs, with a specific interest in comparing the change in Physical Function at 6 months from baseline as a function of weight los
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Weight loss intervention versus self-directed weight loss.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Vered Stearns, M.D., Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871116
- Sponsor's protocol ID
- J12128
- Other IDs
- J12128
- Status last verified
- Jan 2018
- First submitted
- 3 Jun 2013
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: All participant data is deidentified and will be grouped together when presenting results.
Publications
Sheng JY, Chen R, Rosner GL, Snyder CF, Appel LJ, Stearns V, Smith MT, Coughlin JW. The Impact of Baseline Sleep as a Potential Moderator of Weight Loss Intervention in Breast Cancer Survivors: Results From the POWER-Remote Trial. Obesity (Silver Spring). 2026 Feb;34(2):334-343. doi: 10.1002/oby.70096. Epub 2025 Dec 15.
PubMed 41397701
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating the Effect of a Remote-Based Weight Loss Program (POWER-remote) on Biomarkers in Women With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01871116
- Acronym / sponsor ID
- J12128
- Conditions
- Early Stage Breast Cancer
- Keywords
- breast cancer, early stage, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Jun 2013 (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 research is being done to assess the effectiveness of a weight loss program in women with early stage breast cancer whose body mass index (BMI) is in the overweight or obese range (>25). Weight loss is beneficial in improving cardiovascular risk factors and overall health, but may also decrease the chance of breast cancer coming back. A weight loss counseling program was studied in a general population and was found to be effective to help reduce weight over a 2 year period.
The main goal of this study is to determine if women with a recent diagnosis of early breast cancer will also lose weight with this program. To better understand the effect that weight loss has on women with breast cancer, we will compare the patterns in blood and breast tissue samples (tissue biopsies will be optional), and questionnaires evaluating different aspects of one's well-being, before and after a dietary intervention or no intervention.
Detailed description
The prevalence of obesity has increased rapidly in recent years. Epidemiological studies since the 1970's have strongly suggested that excess body weight gain may be a major risk factor for many cancers including breast cancer. In addition, once diagnosed with breast cancer, women who are overweight or obese experience worse outcomes despite standard local and adjuvant therapy. Furthermore, most women gain weight following a diagnosis of breast cancer, and this weight gain may increase risk of recurrence by 40-50% and breast cancer-related mortality by 53-60%.
A great deal of effort has been made for many years to explain the relationship between obesity and breast cancer. Molecularly, the relationship involves dynamic and complex interactions between a milieu of hormones, cytokines, adipokines, affecting cell signaling and potentially epigenetic pathways. Recently, studies in postmenopausal women have shown that weight loss modulates these cytokines and adipokines favorably. Inflammation associated with obesity can also be characterized pathologically when macrophages surround necrotic adipocytes in what are called crown-like structures (CLS). Furthermore, increased central obesity as measured by waist-to-hip ratios, may be associated with hypermethylation of certain breast cancer genes, and physical activity can reduce methylation of certain breast cancer-associated genes.
The Women's Intervention Nutrition Study (WINS) demonstrated that women with early-stage breast cancer receiving conventional cancer management randomized to a dietary intervention group had lower risk of relapse compared to those in a control group in those who lost weight. While women with a diagnosis of breast cancer are therefore recommended to maintain ideal body weight, limited progress has been made in developing feasible weight loss programs. However, collaborators from the Welch Center for Prevention, Epidemiology, and Clinical Research at the Johns Hopkins University have recently reported impressive and sustained weight loss in randomized controlled trials designated Practice-based Opportunities for Weight Reduction (POWER) in obese women with at least one cardiovascular risk factor using a remote-support weight loss intervention.
The overall goal of this study is to determine the effectiveness of the remote-support weight loss intervention of the POWER study, designated POWER-remote, in women with early breast cancer who are overweight or obese, and to assess the effects of weight loss of ≥5% body weight at 6 months and on biomarkers associated with obesity, inflammation, and breast cancer. The data will be used to implement a clinical intervention available to all overweight and obese women with breast cancer, and to design definitive studies assessing the impact of weight loss and biomarker modulation on risk of recurrent disease or development of new primary breast cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Weight loss intervention versus self-directed weight loss.
| Arm | Type | Receives |
|---|---|---|
| POWER-remote | Experimental | Behavioral: POWER-remoteParticipants will start a weight loss program called POWER-remote for Breast Cancer Survivors. This program involves two main components: an online portion accessed on a computer through the internet and a telephone portion to help monitor progress. |
| Self-directed | Active comparator | Behavioral: Self-directedParticipants will receive a pamphlet entitled "Aim for a Healthy Weight", to help guide weight loss goals without access to the web-based POWER-remote system and coach support. |
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)
- Women
- 18 years or older
- Ductal carcinoma in situ (DCIS) or stage I-III invasive breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs, and willing to lose >5% of their body weight. NOTE: Participants may not have documented weight loss greater than 5% of body weight from time of diagnosis. Exceptions that are felt to be due to surgical or other procedures (e.g., mastectomies or reconstruction) may be allowed with prior approval of the Protocol Chair/designee.
Key exclusion criteria (5 listed)
- History of another prior cancer within the last 5 years, with the exception of another breast cancer, adequately treated cone-biopsied in situ carcinoma of the cervix uteri, and basal or squamous cell carcinoma of the skin
- Medical condition likely to hinder accurate measurement of weight, including any condition: for which weight loss is contraindicated, which would likely cause weight loss, or which would affect adipokine and inflammatory markers (e.g., end stage renal disease (ESRD) on dialysis, cirrhosis, autoimmune disease, adrenal disease, and history of bariatric surgery).
- The use of the following medications are excluded: insulin or sulfonylureas; patients with thyroid disease who are not on stable doses of thyroid medication for at least the past 6 months; medications that cause weight loss (e.g., topiramate, bupropion, exenatide, lorcaserin, phentermine or orlistat) within the past 3 months; medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months; medications that may affect adipokine or inflammatory markers (e.g., sulfonylureas, glitazones, insulin, steroids, ACE inhibitors, beta blockers and statins) unless started ≥3 months prior to enrollment, or chronic NSAIDS (defined as use of ≥3 times a week) for ≥1 month.
- Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
- Currently enrolled or planning to enroll in a weight loss program (e.g., Innergy, Weight Watchers, Jenny Craig, Nutrisystem, and Medifast).
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 |
|---|---|---|
| POWER-remoteWeb-based weight loss program. | Behavioural | POWER-remote |
| Self-directedPamphlet entitled "Aim for a Healthy Weight" will be given. | Behavioural | Self-directed |
Primary outcome
Change in body weight
Time frame: After 12 months
To compare the proportion of women with early stage breast cancer, who have completed all local therapy and adjuvant chemotherapy, who lose ≥5% of their baseline body weight after 6 and 12 months between a control arm (self-directed weight loss) and an experimental arm (POWER-remote)
2 secondary outcomes
Change in biomarkers
Time frame: After 12 months
Change in PROs (Patient Reported Outcomes)
Time frame: After 12 months
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 5 Feb 2018.
- Derived from this study: PubMed 41397701Sheng JY, Chen R, Rosner GL, Snyder CF, Appel LJ, Stearns V, Smith MT, Coughlin JW. The Impact of Baseline Sleep as a Potential Moderator of Weight Loss Intervention in Breast Cancer Survivors: Results From the POWER-Remote Trial. Obesity (Silver Spring). 2026 Feb;34(2):334-343. doi: 10.1002/oby.70096. Epub 2025 Dec 15.
- Individual participant dataSharing planned: No. All participant data is deidentified and will be grouped together when presenting results.
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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.
Vered Stearns, M.D. study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWER-remote and Self-directed in people with Early Stage Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 5 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 5 Feb 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?
Change in body weight (time frame: After 12 months). 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 NCT01871116, which also lists 1 linked publication.
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 5 Feb 2018.