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Breast CarcinomaNCT07819981

Prehabilitation for Improving Outcomes in Breast Cancer Patients Undergoing Neoadjuvant Systemic Treatment and Surgery

A study testing Aerobic Exercise, Bioelectric Impedance Analysis and Consultation in people with Breast Carcinoma, run by City of Hope Medical Center at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This clinical trial evaluates whether a prehabilitation program is feasible for breast cancer patients receiving neoadjuvant systemic treatment before surgery. Many people with breast cancer have problems during and after treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Carcinoma
What is being tested?
Aerobic Exercise, Bioelectric Impedance Analysis and Consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
24 Feb 2027to 24 Jul 2029
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PATIENT INCLUSION:
  • Documented informed consent of the participant and/or legally authorized representative
  • Willingness to comply with a physiatry consultation, start a tailored training program, and follow-up assessments
  • Age: >= 18 years
  • Able to read and write in English
  • A diagnosis of breast cancer planned for curative intent neoadjuvant systemic treatment (NST) with a goal of breast cancer surgery
Show all 11Show fewer
  • Plan to start NST at City of Hope Orange County
  • HEALTHCARE TEAM INCLUSION:
  • Willingness to complete the Healthcare Team Feedback Survey
  • > 18 years old
  • Physicians, advanced practice providers, nurses, medical assistants, rehabilitation therapists, social workers, dietitians, mental health professionals, and other clinical staff who interact with study participants in the course of routine care

Who cannot join

  • PATIENT EXCLUSION:
  • Current or planned cancer treatment for a second cancer not of breast origin
  • Clinically significant uncontrolled illness limiting participation with the research intervention and assessments
  • Cancer with distant metastases
  • Other active malignancy
  • Pregnant or breastfeeding
Show all 13Show fewer
  • Physician judgment (based on information gathered during consult visit) of medical instability including conditions such as unstable cardiopulmonary status, recent embolism (< 4 weeks), suspected or known dissecting aneurysm, severe hypertension (resting blood pressure > 180/110), chronic infectious disease, uncontrolled metabolic disease (e.g. diabetes with ketosis), active seizure, mental/physical impairments limiting safe exercise, or sepsis
  • Meeting or exceeding exercise guidelines over the last one month, based on the responses from the Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire
  • Started second cycle before the physiatry consult
  • Inability to independently follow instructions for study assessments for any reason such as mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with the prehabilitation interventions or with the data collection process.)
  • Unable to independently answer questionnaires in English or provide informed consent for any reason
  • HEALTHCARE TEAM EXCLUSION:
  • Healthcare workers who do not interact with study participants and therefore cannot provide relevant feedback

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • City of Hope Medical Center

    Duarte, California, 91010

    Jessica Cheng, 949-759-2863, jescheng@coh.org

    Jessica Cheng

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Jessica Cheng, 949-759-2863, jescheng@coh.org

    Jessica Cheng

Other trials in United States

About this study

Official title: Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Breast Cancer Surgery: A Pilot Feasibility Study

This clinical trial evaluates whether a prehabilitation program is feasible for breast cancer patients receiving neoadjuvant systemic treatment before surgery. Many people with breast cancer have problems during and after treatment. These issues can make daily activities harder and make it harder for a person to enjoy daily life. Some people with breast cancer already have other health problems, like joint pain or nerve problems, which can make these symptoms worse. Research shows that being stronger and more active before and during treatment may help people do better during cancer care and recover more easily. However, many patients do not get this type of support early enough. Prehabilitation is a program that helps patients get ready for cancer treatment and surgery. It may include help with medical care, exercise, food and nutrition, and mental health. The goal is to help patients stay as strong and healthy as possible before surgery. Starting prehabilitation during neoadjuvant systemic treatment before surgery may help breast cancer patients feel better, stay stronger and recover more easily during treatment.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine feasibility based on exercise as evaluated by adherence (> 70%). II. Assess feasibility of nutrition and mind/spirit practice by measuring adherence (> 70% of enrolled patients for the preoperative study period).

SECONDARY OBJECTIVES:

  1. Evaluate physical measures: six minute walk test, Duke Activity Status Index, 30-second sit to stand, Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3 Dimensional (3D) Profile, body composition, and Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH).

II. Assess exercise behavior measures: Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire, self-reported exercise activity and future intent, self-efficacy for home exercise programs.

III. Evaluate malnutrition risk with Malnutrition Screening Tool. IV. Assess psychological and spiritual distress with relevant measures within the Edmonton Symptom Assessment Scale- Financial and Spiritual Distress (ESAS-FS) and European Quality of Life 5 Dimensions (EQ-5D-5L).

  1. Evaluate symptom burden with ESAS-FS and health-related quality of life with EQ-5D-5L.

EXPLORATORY OBJECTIVES:

  1. Evaluate disease outcomes as measured by relative dose intensity and pathologic complete response.

II. Assess cancer treatment timing by examining time from diagnosis to surgery, time from last chemotherapy cycle to surgery, time from surgery to adjuvant treatment, hospitalizations and length of stay.

III. Evaluate cancer treatment complications measured by the incidence of chemotherapy-induced peripheral neuropathy (using Common Terminology Criteria for Adverse Events [CTCAE] 5.0).

IV. Identify future program improvements via enrollment rate, adherence to prescribed nutrition and mental health interventions assessed via weekly logs, a participant feedback survey, clinician feedback survey, reasons for non-participation, challenges to intervention adherence, and days to consult completion.

  1. Document the utilization of multidisciplinary specialty services.

OUTLINE:

Patients attend cancer physiatry consultations over 1 hour prior to surgery on days 0 and 42, as-needed after day 42 but prior to surgery, and then on day 168 following surgery. At consultation visits, patients receive prehabilitation education and tailored recommendations for a multimodal home-based program consisting of aerobic exercise, resistance exercise, nutrition, and psychospiritual care. Patients are recommended to participate in 30 minutes of light intensity aerobic exercise on "bad days" during chemotherapy and at least 30 minutes three times per week at moderate intensity on "good days" during chemotherapy. If patients complete chemotherapy, they are recommended to participate in 30 minutes of moderate intensity or 15 minutes of vigorous intensity exercise 5-10 times per week. Patients are also recommended to participate in resistance exercise 2-3 times per week, with a rest day between each session during and after completion of chemotherapy. Patients receive nutritional guidance regarding protein intake and are encouraged to consume 3-4 portions per day, ideally within 1 hour of exercise. Patients also receive recommendations for psychospiritual skills to practice, with a goal of practicing one skill or activity daily. Patients receive educational materials containing practical tips and resources for sleep hygiene, energy conservation, and maintenance of physical mobility during hospitalization. Patients may receive additional referrals to physical therapy, occupational therapy, registered dietitian, and/or clinical social work as needed.

Being tested
Aerobic Exercise, Bioelectric Impedance Analysis, Consultation, Educational Intervention, Electronic Health Record Review
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Aerobic ExerciseOther

    Also called Aerobic Activity

    Participate in aerobic exercise

  • Bioelectric Impedance AnalysisProcedure or surgery

    Also called BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis

    Ancillary studies

  • ConsultationOther

    Also called Consult

    Attend physiatry consultation

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive prehabilitation education

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Nutritional InterventionOther

    Receive nutritional guidance

  • Physical Performance TestingOther

    Also called Physical Fitness Testing, Physical Function Testing

    Ancillary studies

  • Psychosocial CareBehavioural

    Also called Psychosocial Support

    Receive psychospiritual care

  • Questionnaire AdministrationOther

    Ancillary studies

  • ReferralOther

    Also called Referred

    Receive referral(s)

  • Resistance TrainingOther

    Also called Strength Training

    Participate in resistance exercise

  • Spiritual TherapyProcedure or surgery

    Receive psychospiritual care

  • Tailored InterventionProcedure or surgery

    Receive tailored prescriptions and recommendations

Study groups in NCT07819981
Study groupRoleWhat they receive
Supportive care (prehabilitation)ExperimentalSee Detailed Description.
Receives: Other: Aerobic Exercise; Procedure: Bioelectric Impedance Analysis; Other: Consultation; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Nutritional Intervention; Other: Physical Performance Testing; Behavioral: Psychosocial Care; Other: Questionnaire Administration; Other: Referral; Other: Resistance Training; Procedure: Spiritual Therapy; Procedure: Tailored Intervention

What is being measured

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

  1. Adherence (feasibility)

    Feasibility of exercise will be determined by participant adherence to the prescribed exercise for the evaluable preoperative study period with goal of adherence of > 70% for > 70% of the preoperative time period. Adherence is defined as a ratio of completed versus planned exercise amount (90 minutes per week of moderate intensity aerobic exercise when on neoadjuvant systemic treatment (NST), 150 minutes per week when off NST, and 2 times per week resistance exercise), averaged between the types of exercise. Feasibility of nutrition and mind/spirit practice will also be determined based on participant adherence (> 70% of enrolled patients during the preoperative time period).

    Measured: Up to day 168

Secondary outcomes (16)

  1. Six minute walk test

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  2. Duke Activity Status Index

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  3. 30-second sit to stand

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  4. Short physical performance battery

    This objective assessment tool evaluates lower extremity functioning in frail older adults with good validity and reliability.[100] The three components are 1) static stance in 3 different positions, 2) usual gait speed, and 3) chair stand five times. The minimum detectable change indicates low sensitivity ranging 0.7-3.42.

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  5. Patient Reported Outcomes Measurement Information System Cancer Function Brief 3-dimensional Profile

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  6. Body composition: Body composition measures, including but not limited to fat-free mass

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  7. Quick Disabilities of Arm, Shoulder, and Hand

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  8. Godin Leisure-Time Physical Activity and Exercise Intent Questionnaire:

    Godin Leisure-Time Physical Activity and Exercise Intent this questionnaire (estimated completion time of one minute) consists of 6 self-administered questions about the number of light (minimal effort), moderate (not exhausting), and strenuous (heart beats rapidly) 15-minute bouts of leisure time physical activity (LTPA) in a typical 7-day period.

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  9. Self-reported exercise-Survey

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  10. Intent to exercise- Survey

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  11. Self-Efficacy for Home Exercise Programs

    This is a 12-question patient-reported outcome measure based on the Self-Efficacy for Exercise (SEE) scale. Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  12. Malnutrition Screening Tool

    This is a 2-question measure that is endorsed by the Academy of Nutrition and Dietetics for use in adults regardless of age, medical history, or setting. Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  13. Edmonton Symptom Assessment Scale - Financial and Spiritual Distress

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  14. European Quality of Life 5 Dimensions

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  15. Body composition: Body composition measures, including fat mass

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

  16. Body composition: Body composition measures, including phase angle

    Changes in the outcome measures between any two time points of interest will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality).

    Measured: At baseline, day 42, day 84, day 126, at pre-operative visit, and post-operative visit (21-35 days after surgery [approximately day 168])

Timeline

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

  1. First posted15 Sep 2026
  2. Study start24 Feb 2027 (estimated)
  3. Primary completion24 Jul 2029 (estimated)
  4. Study completion24 Jul 2029 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07819981
Sponsor's protocol ID
24284
Other IDs
NCI-2026-05688, 24284, P30CA033572
Status last verified
Sep 2026
First submitted
18 Aug 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise, Bioelectric Impedance Analysis and Consultation in people with Breast Carcinoma, run by City of Hope Medical Center 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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 15 Sep 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (feasibility) (time frame: Up to day 168). 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 NCT07819981.

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 15 Sep 2026.

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