Breast CancerNCT04720209
Taking AIM at Breast Cancer
A study testing CARE, TARE and Home-Based Stretching in people with Breast Cancer and Breast Cancer Stage I, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- CARE, TARE and Home-Based Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2021to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 diagnosed with breast cancer (all stages excluding stage IV), low grade disease positive for estrogen and progesterone receptors
- Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
- The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. Patients must undergo a pregnancy test via urine strip that will be covered and provided by the PI. Urine strips will be utilized over bloodwork for cost effectiveness. Urine tests will be distributed once before DEXA scans.
- Are centrally obese with the following criteria[57] (determined by study team at eligibility screening): BMI >30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat >30% (estimated by bioelectrical impedance), and waist circumference >35 in.
- Have undergone a lumpectomy or mastectomy.
- If cancer treatment included neoadjuvant or adjuvant chemotherapy and/or radiation therapy, participant must have received and completed treatment.
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- Speak English
- Is in breast cancer remission with no detectable disease present
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease.
- Have not experienced a weight reduction ≥10% within the past 6 months
- Currently participate in less than 60 minutes of structured exercise/week
- No planned reconstructive surgery with flap repair during trial and follow-up period
- May use adjuvant endocrine therapy, trastuzumab or pertuzumab if use will be continued for duration of study intervention
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to Dana-Farber Cancer Institute
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease
- Is not centrally obese as defined above
- Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
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- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Participates in more than 60 minutes of structured exercise/week
- Is planning reconstructive surgery with flap repair during trial and follow-up period
- Currently smokes
- Is unable to travel to the exercise facilities
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
The purpose of this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue.
Read the detailed description
This study is about using different types of exercise to reduce inflammation in fat tissue in an effort to minimize the risk of cancer recurrence related to being overweight or obese. The investigators hope to learn whether participating in a specific exercise program can cause inflammation in the fat tissue to decrease.
The names of the study interventions involved in this study are:
- Circuit-style aerobic and resistance exercise (CARE)
- Traditional aerobic and resistance exercise (TARE)
The research study procedures include screening for eligibility, and study treatment including evaluations and follow up visits.
The study treatment will be for 4 months and participants will followed for 8 months.
The total time for participation in this study will be about 12 months. It is expected that about 300 people will take part in this research study.
- Being tested
- CARE, TARE, Home-Based Stretching
- Keywords
- Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREOther
CARE is a 16-week, supervised, periodized AE and RE program performed in a circuit fashion 3 days/week on-site
TAREOther
TARE is a 16- week, supervised AE and RE program consisting of three sessions per week on-site
Home-Based StretchingOther
This group will perform a home-based program of the same stretches utilized in the CARE and TARE groups.
| Study group | Role | What they receive |
|---|---|---|
| Circuit-style aerobic and resistance Exercise(CARE) | Experimental | This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months.
-16 weeks of circuit-style aerobic and resistance exercise Receives: Other: CARE |
| Traditional Aerobic Resistance Exercise (TARE) | Experimental | This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months
- 16 weeks of traditional aerobic and resistance exercise Receives: Other: TARE |
| Home-Based Stretching | Active comparator | Attention Control for 16 weeks home-based stretching
-structured home-based stretching program, participants will be asked to maintain their current activity level for the 4-month study duration, and will be offered the CARE program upon study completion Receives: Other: Home-Based Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in adipose tissue levels of inflammation.
Adipose tissue inflammation will be assessed by measuring: M1 and M2 adipose tissue macrophages (ATMs)
Measured: 16 Weeks
Decrease in adipose tissue levels of inflammation.
Adipose tissue inflammation will be assessed by measuring: leptin, adiponectin, IL-6 and IL-8
Measured: 16 weeks
Decrease in adipose tissue levels of inflammation.
Adipose tissue inflammation will be assessed by measuring: hs-CRP and TNF-a
Measured: 16 weeks
Secondary outcomes (1)
4-month CARE intervention on sarcopenic obesity.
sarcopenic obesity will be assessed via dual energy X-ray absorptiometry using a validated equation.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start13 Aug 2021
- Primary completion31 Oct 2026 (estimated)
- Study completionDec 2028 (estimated)
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 Dana-Farber Cancer InstituteThe 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina M Dieli-Conwright, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720209
- Sponsor's protocol ID
- 20-172
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04720209
- Acronym / sponsor ID
- 20-172
- Keywords
- Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jan 2021 (actual)
- 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 this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue.
Detailed description
This study is about using different types of exercise to reduce inflammation in fat tissue in an effort to minimize the risk of cancer recurrence related to being overweight or obese. The investigators hope to learn whether participating in a specific exercise program can cause inflammation in the fat tissue to decrease.
The names of the study interventions involved in this study are:
- Circuit-style aerobic and resistance exercise (CARE)
- Traditional aerobic and resistance exercise (TARE)
The research study procedures include screening for eligibility, and study treatment including evaluations and follow up visits.
The study treatment will be for 4 months and participants will followed for 8 months.
The total time for participation in this study will be about 12 months. It is expected that about 300 people will take part in this research study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circuit-style aerobic and resistance Exercise(CARE) | Experimental | Other: CAREThis research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months. -16 weeks of circuit-style aerobic and resistance exercise |
| Traditional Aerobic Resistance Exercise (TARE) | Experimental | Other: TAREThis research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months - 16 weeks of traditional aerobic and resistance exercise |
| Home-Based Stretching | Active comparator | Other: Home-Based StretchingAttention Control for 16 weeks home-based stretching -structured home-based stretching program, participants will be asked to maintain their current activity level for the 4-month study duration, and will be offered the CARE program upon study completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Women diagnosed with breast cancer (all stages excluding stage IV), low grade disease positive for estrogen and progesterone receptors
- Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
- The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. Patients must undergo a pregnancy test via urine strip that will be covered and provided by the PI. Urine strips will be utilized over bloodwork for cost effectiveness. Urine tests will be distributed once before DEXA scans.
- Are centrally obese with the following criteria[57] (determined by study team at eligibility screening): BMI >30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat >30% (estimated by bioelectrical impedance), and waist circumference >35 in.
- Have undergone a lumpectomy or mastectomy.
Key exclusion criteria (12 listed)
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease
- Is not centrally obese as defined above
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 |
|---|---|---|
| CARECARE is a 16-week, supervised, periodized AE and RE program performed in a circuit fashion 3 days/week on-site | Other | Circuit-style aerobic and resistance Exercise(CARE) |
| TARETARE is a 16- week, supervised AE and RE program consisting of three sessions per week on-site | Other | Traditional Aerobic Resistance Exercise (TARE) |
| Home-Based StretchingThis group will perform a home-based program of the same stretches utilized in the CARE and TARE groups. | Other | Home-Based Stretching |
Primary outcome
Decrease in adipose tissue levels of inflammation.
Time frame: 16 Weeks
Adipose tissue inflammation will be assessed by measuring: M1 and M2 adipose tissue macrophages (ATMs)
Decrease in adipose tissue levels of inflammation.
Time frame: 16 weeks
Adipose tissue inflammation will be assessed by measuring: leptin, adiponectin, IL-6 and IL-8
Decrease in adipose tissue levels of inflammation.
Time frame: 16 weeks
Adipose tissue inflammation will be assessed by measuring: hs-CRP and TNF-a
1 secondary outcome
4-month CARE intervention on sarcopenic obesity.
Time frame: 16 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Christina M Dieli-Conwright, PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE, TARE and Home-Based Stretching in people with Breast Cancer and Breast Cancer Stage I, run by Dana-Farber Cancer Institute at 2 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 17 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Decrease in adipose tissue levels of inflammation. (time frame: 16 Weeks). The study lists 3 primary outcomes in all. 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 8 Oct 2026.