Recruiting

Resistance Exercise

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05535192

Conditions

Breast Cancer

Stage III Breast Cancer

Breast Cancer Female

Stage I Breast Cancer

Stage II Breast Cancer

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

Interventions

THRIVE

Health Education Support Program

Study Details

Brief summary:

This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.

Conditions

Breast Cancer

Stage III Breast Cancer

Breast Cancer Female

Stage I Breast Cancer

Stage II Breast Cancer

Study ID

NCT05535192

Start date

Mar 20, 2023

Status verified date

Apr, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women age >=65
  • Diagnosed with stage I-III invasive breast cancer
  • BMI between 18-50 kg/m2
  • Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent
  • If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents/doses according to patient response (e.g.; I-SPY trials)
  • Self-reported ability to walk for 6 minutes and/or 2 blocks (with or without assistive device)
  • Ability to provide written informed consent.
  • Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters.

Exclusion Criteria:

  • Following a therapeutic diet for co-morbid disease where the THRIVE-65 diet would be contraindicated as assessed by the RD
  • Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months over the past year
  • Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year
  • Presence of medical conditions or medications that would prohibit participation in an exercise program
  • Current use of weight-loss medication
  • Documented history of alcohol or substance abuse within the past 12 months
  • History of dementia

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: HEALTH EDUCATION AND SUPPORT CONTROL GROUP

The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the Heath Education Support Program will receive a tablet from the study that is pre-loaded with material to help support them during chemotherapy. The tablet materials will include supportive care and resources that focus on movement (light stretching and gentle yoga), soothing music, meditation/mindfulness, and recipes/cooking demos. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy and the amount of time they spend engaging with the tablet. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.

experimental: THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT

The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the THRIVE Exercise and Diet Intervention will work with a coach to gradually build exercise and stay active during chemotherapy treatment. Participants will work with an exercise coach to reach the muscle strengthening and aerobic exercise goals of the study. Participants will also consult with a dietician to ensure adequate protein intake during the study. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.

Interventions

THRIVE

The THRIVE Intervention will involve:

1\) one in-person exercise sessions, followed by twice-weekly, home-based exercise sessions, supervised remotely through telehealth, and 2) a remotely delivered dietary assessment and recommendations to support protein intake throughout the study

Health Education Support Program

Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy

Primary outcome measure

  • Received Dose Intensity (RDI) [ Time Frame: Baseline to 26 weeks ]

Central Contacts and Locations

Central contacts

Kathryn Schmitz, PhD, MPH

412-623-6216schmitzk@upmc.edu

Jennifer Ligibel, MD

617-632-3800jennifer_ligibel@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jennifer Ligibel, MD

617-632-3800Jennifer_Ligibel@dfci.harvard.edu

Principal Investigator:

Jennifer Ligibel, MD

Case Western Reserve University/University Hospitals Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Cynthia Owusu, MD

cxo34@case.edu

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Kathryn Schmitz, PhD, MPH

412-623-6216schmitzk@upmc.edu

Mount Nittany Medical Center

Recruiting

State College, Pennsylvania, United States, 16803

Contacts

Shannon Fisher

8142317813sfisher@mountnittany.org

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jul 17, 2026

Last verified

Apr, 2026

Keywords

  • Breast Cancer
  • Stage III Breast Cancer
  • Stage II Breast Cancer
  • Stage I Breast Cancer
  • Exercise Intervention
  • Nutrition Intervention
  • Supportive Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-07-17.