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Not yet recruiting NCT07529353

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

No phase Interventional Breast Cancer Cancer Related Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EXCAP Exercise Program, 10-Hour Healthy Eating Timeframe (hEAT).
Who it may be relevant to
Registry conditions: Breast Cancer, Cancer Related Fatigue. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral EXCAP Exercise Program
    Home-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks.
  • Behavioral 10-Hour Healthy Eating Timeframe (hEAT)
    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 outcome measures

  • Proportion of Participants Meeting Pre-Specified Adherence Criteria [Time frame: Baseline to Day 42]
Secondary outcome measures (6)
  • Mean Change in Brief Fatigue Inventory Total Score [Time frame: Baseline to Day 42]
  • Mean Change in Multidimensional Fatigue Symptom Inventory Total Score [Time frame: Baseline to Day 42]
  • Mean Change in Body Mass Index [Time frame: Baseline to Day 42]
  • Mean Change in 30-Second Bicep Curl Test Repetitions [Time frame: Baseline to Day 42]
  • Mean Change in 30-Second Chair Stand Test Repetitions [Time frame: Baseline to Day 42]
  • Mean Change in Estimated Submaximal VO2 [Time frame: Baseline to Day 42]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Wilmot Cancer Institute — Rochester

Identifiers

NCT: NCT07529353 · STUDY00010857

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗