Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07529353

Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' .

This study evaluates the feasibility and preliminary effects of a home based exercise and activity program for individuals with cancer. Participants will engage in a structured intervention designed to support physical activity and symptom management. The study will assess changes in patient reported outcomes, functional measures, and overall adherence to the program. Findings will help determine whether this approach is practical and potentially beneficial for improving health related outcomes in this population.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer Related Fatigue Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location contact

Lindsey Mattick, PhD MS

CONTACT

[email protected]

5852740473

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be aged 18 years or older
  • Must have a confirmed diagnosis of breast cancer (stage I-IIIC)
  • Must have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 2 - 120 months prior to enrolling,
  • Must be prescribed adjuvant endocrine therapy,
  • Must have a baseline level of fatigue, as determined by reporting a score of 4 or higher on the Symptom Inventory
  • Must have a body mass index greater than or equal to 25 kg per meter squared
  • Must have the ability to ambulate independently
  • Must be willing and able to participate in home-based exercise and eating timeframe intervention
  • Must have the ability to read and understand the English language,

Exclusion criteria

  • Must not have metastatic or recurrent breast cancer
  • Must not be currently receiving chemotherapy or radiation therapy
  • Must not have a medical condition that would preclude safe participation in intervention or study procedures
  • Must not be pregnant, or planning to become pregnant during the study period
  • Must not be in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form,
  • Must not have any condition that in the opinion of the investigator would interfere with participation or safety
  • Must not be currently using, or plan to initiate use of prescription or over-the-counter weight-loss medications

Treatment and study plan

EXCAP Exercise Program

Behavioral

Home-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks.

10-Hour Healthy Eating Timeframe (hEAT)

Behavioral

Participants will self-select and maintain a daily eating window of 10 hours or less for 6 weeks, with timing of first and last meals recorded daily.

Primary outcomes

  1. Proportion of Participants Meeting Pre-Specified Adherence Criteria

    Time frame: Baseline to Day 42

    Percentage of participants who meet all three adherence criteria during the 6-week intervention:

    Maintain a ≤10-hour eating timeframe on at least 50 percent of intervention days (21 of 42 days)

    Complete resistance band exercises at least 12 total sessions during the 6-week period

    Increase average weekly step count by at least 20 percent from baseline to Week 6

Secondary outcomes

  1. Mean Change in Brief Fatigue Inventory Total Score

    Time frame: Baseline to Day 42

    Mean difference in total BFI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue.

  2. Mean Change in Multidimensional Fatigue Symptom Inventory Total Score

    Time frame: Baseline to Day 42

    Mean difference in total MFSI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue burden.

  3. Mean Change in Body Mass Index

    Time frame: Baseline to Day 42

    Mean difference in BMI (kg/m²) measured at baseline and at Day 42.

  4. Mean Change in 30-Second Bicep Curl Test Repetitions

    Time frame: Baseline to Day 42

    Mean difference in total number of completed bicep curl repetitions within 30 seconds from baseline to Day 42.

  5. Mean Change in 30-Second Chair Stand Test Repetitions

    Time frame: Baseline to Day 42

    Mean difference in total number of completed chair stands within 30 seconds from baseline to Day 42.

  6. Mean Change in Estimated Submaximal VO2

    Time frame: Baseline to Day 42

    Mean difference in estimated VO2submax (mL/kg/min) obtained from treadmill testing at baseline and Day 42.

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsey Mattick, PhD

CONTACT

[email protected]

5852740473

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' (EXCAP-hEAT) Among Breast Cancer Survivors Receiving Adjuvant Endocrine Therapy.

Acronym: EXCAP-hEAT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.