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Cancer SurvivorNCT03091842

Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer

A study testing Exercise Intervention, Informational Intervention and Laboratory Biomarker Analysis in people with Cancer Survivor and Central Obesity, run by University of Southern California at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Exercise Intervention, Informational Intervention and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
29 Jul 2019to 29 Jul 2025
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

  • Postmenopausal (at time of diagnosis; including artificial menopause induced by previous hysterectomy) women newly diagnosed (stage I-III) breast cancer low grade disease positive for estrogen and progesterone receptors
  • Are centrally obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 30 kg/m^2 (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 inches (in)
  • Have undergone a lumpectomy or mastectomy
  • Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months
  • Speak English or Spanish
  • Is in breast cancer remission with no detectable disease present
Show all 14Show fewer
  • 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 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 if use will be continued for duration of study intervention
  • Does not smoke (no smoking during previous 12 months)
  • Willing to travel to the exercise facility at University of Southern California (USC)

Who cannot join

  • Patients with metastatic disease
  • Is not centrally obese
  • Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
  • 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 facility at USC

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors

This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the risk of cancer recurrence related to being overweight or obese.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on obesity-associated chronic inflammation.

SECONDARY OBJECTIVES:

  1. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.

TERTIARY OBJECTIVES:

  1. To determine the effects of a 4-month CARE intervention on breast cancer prognosis and assess whether reductions in chronic inflammation are associated with breast cancer prognosis.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.

GROUP II: Patients undergo supervised traditional aerobic and resistance exercise (TARE) program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.

GROUP III: Patients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive instructional digital video disc (DVD) and booklet of the flexibility exercises. Patients also complete a weekly activity log. After completion of the stretching program, patients may optionally undergo the CARE program as in group I.

After completion of study, patients are followed up at week 34, 8 and 12 months, and then every year for 8 years.

Being tested
Exercise Intervention, Informational Intervention, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Obesity, Abdominal, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise InterventionBehavioural

    Undergo supervised CARE program

  • Exercise InterventionBehavioural

    Undergo supervised TARE program

  • Exercise InterventionBehavioural

    Undergo home-based stretching program

  • Informational InterventionOther

    Receive instructional DVD and booklet of the flexibility exercises

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03091842
Study groupRoleWhat they receive
Group I (CARE program)ExperimentalPatients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (TARE program)ExperimentalPatients undergo supervised TARE program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment
Group III (home-based stretching program)Active comparatorPatients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive instructional DVD and booklet of the flexibility exercises. Patients also complete a weekly activity log. After completion of the stretching program, patients may optionally undergo the CARE program as in group I.
Receives: Behavioral: Exercise Intervention; Other: Informational Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of adipose tissue inflammation assessed by measuring M1 and M2 adipose tissue macrophages, crown-like structures, and adipose tissue secretion levels of inflammatory cytokines secreted

    Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes. Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period. Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month). The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes.

    Measured: Up to 16 weeks

Secondary outcomes (4)

  1. Distant DFS defined as events that are either lethal (death from any cause) or a direct threat to patient survival (distant recurrence or second primary invasive cancer)

    Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).

    Measured: Up to 8 years

  2. Overall survival

    Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).

    Measured: From randomization to death from any cause, assessed up to 8 years

  3. Recurrence-free interval defined as events directly attributable to the original breast cancer including invasive ipsilateral breast tumor recurrence; local, regional or distant recurrence; and death from breast cancer

    A competing risks analysis will be conducted, with death modeled as a competing event, using the Fine-Gray proportional hazards model. Analyses will be presented unadjusted, as well as adjusted for prognostic variables (age, estrogen receptor (ER)/HER2 status, tumor size, presence/number of positive nodes, and surgery (mastectomy vs. breast-sparing).

    Measured: Up to 8 years

  4. Sarcopenic obesity assessed using dual energy X-ray absorptiometry

    Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes. Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period. Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month). The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes.

    Measured: Up to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2017
  2. Study start29 Jul 2019 (estimated)
  3. Primary completion29 Jul 2024 (estimated)
  4. Study completion29 Jul 2025 (estimated)

Why it stopped: PI left

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03091842
Sponsor's protocol ID
1B-16-11
Other IDs
NCI-2017-00070, 1B-16-11, P30CA014089
Status last verified
Oct 2019
First submitted
21 Mar 2017
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kang DW, Wilson RL, Gonzalo-Encabo P, Norris MK, Hans M, Tahbaz M, Dawson J, Nguyen D, Normann AJ, Yunker AG, Sami N, Uno H, Ligibel JA, Mittelman SD, Dieli-Conwright CM. Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors (The AIM Trial): Rationale, Design, and Methods. Front Oncol. 2022 Jun 20;12:896995. doi: 10.3389/fonc.2022.896995. eCollection 2022.

    PubMed 35795051

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention, Informational Intervention and Laboratory Biomarker Analysis in people with Cancer Survivor and Central Obesity, run by University of Southern California 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 14 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: withdrawn, as of the sponsor's last update on 24 Oct 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 was withdrawn before enrolling participants, so there are no results.

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?

Reduction of adipose tissue inflammation assessed by measuring M1 and M2 adipose tissue macrophages, crown-like structures, and adipose tissue secretion levels of inflammatory cytokines secreted (time frame: Up to 16 weeks). 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 NCT03091842, 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 24 Oct 2019.

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