Exercise and Healthy Eating for Cancer

(EXCAP-hEAT Trial)

LM
Overseen ByLindsey Mattick, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based exercise and healthy eating program can help people with breast cancer manage symptoms and improve health. Participants will follow a 6-week plan combining aerobic walking, resistance training, and a daily 10-hour healthy eating window (hEAT). The trial seeks individuals who have completed initial cancer treatments, experience fatigue, and are willing to try this lifestyle approach at home.

As an unphased trial, this study provides a unique opportunity to explore new lifestyle strategies for managing breast cancer symptoms.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must not be using or planning to use weight-loss medications.

What prior data suggests that this exercise and healthy eating program is safe for individuals with cancer?

Research has shown that the 10-hour healthy eating timeframe (hEAT) is generally safe and can benefit health. Studies indicate that eating within a 10-hour period can improve blood sugar and cholesterol levels. This method has also proven safe and practical for cancer survivors, helping to reduce fatigue.

The EXCAP exercise program is well-tolerated by cancer patients. Previous studies have demonstrated its ability to improve physical abilities and reduce inflammation. It also helps boost mood and overall quality of life. The program is designed to be safe, even for older adults.

Earlier research has confirmed the safety of both treatments in this study.12345

Why are researchers excited about this trial?

Researchers are excited about the EXCAP-hEAT intervention because it combines exercise and dietary timing in a novel way to support cancer patients. Unlike traditional treatments that focus mainly on medical interventions like chemotherapy or radiation, this approach empowers patients to take control of their health through lifestyle changes. The EXCAP exercise program, featuring aerobic walking and resistance band training, alongside a self-selected 10-hour healthy eating window, offers a holistic method to potentially enhance well-being and improve outcomes. By integrating physical activity and mindful eating, this intervention could provide a complementary strategy to traditional cancer care.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that the 10-hour Healthy Eating Timeframe (hEAT) can benefit people with cancer by enhancing metabolism and quality of life. Consuming all meals within a 10-hour window has been linked to improved blood sugar and cholesterol levels and may reduce cancer-related fatigue. Additionally, the EXCAP Exercise Program has improved physical abilities and reduced symptoms in cancer patients. It also correlates with reduced stress and better chances of remaining cancer-free. In this trial, participants will engage in a combined lifestyle intervention that includes both the hEAT and EXCAP programs, which together may help manage cancer symptoms and improve overall health.12367

Who Is on the Research Team?

LM

Lindsey Mattick, PhD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for adults (18+) with stage I-IIIC breast cancer who finished major treatments 2–120 months ago, have a BMI of 25 or higher, are on hormone therapy, feel moderate fatigue, can walk on their own, read English, and are willing to follow a home exercise and eating schedule.

Inclusion Criteria

I have been diagnosed with stage I-IIIC breast cancer.
* Must have a body mass index greater than or equal to 25 kg per meter squared
I have been prescribed hormone therapy after my main cancer treatment.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-week home-based exercise and activity program, including aerobic walking, resistance band training, and tracking of eating timeframes and physical activity

6 weeks
Home-based, self-monitored

Follow-up

Participants are monitored for changes in patient-reported outcomes, functional measures, and adherence to the program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 10-Hour Healthy Eating Timeframe (hEAT)
  • EXCAP Exercise Program

Trial Overview

The study tests if a home-based exercise program (EXCAP) combined with limiting daily eating to a 10-hour window (hEAT) is practical and helpful for people with breast cancer. It looks at how well participants stick to the plan and its effects on symptoms and function.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: EXCAP-hEAT InterventionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Time-restricted eating and cancer: lessons learned and ... - PMC

... 10 hours led to improved metabolic outcomes and lipid profiles.,, In one study, men with prediabetes randomly assigned to a 6-hour time-restricted eating ...

(PDF) A 10-hour time-restricted eating intervention to ...

Conclusions A 12-week, nutritionist-led TRE program led to less fatigue than control. Continued study of TRE patterns are warranted to optimize this eating ...

The Clinical Impact of Time-restricted Eating on Cancer - PMC

Preliminary findings suggest that TRE is feasible and acceptable by people with cancer, may have oncological benefits, and improves quality of life.

Eating early in the day and within a 10-hour window brings ...

Eating relatively early may be beneficial for weight loss, and keeping meals within a 10-hour period could improve blood sugar and cholesterol levels.

Eating in 10-hour window can override disease-causing ...

Eating in 10-hour window can override disease-causing genetic defects, nurture health. Salk scientists discover that periods of fasting can protect against ...

Individual Dietary Choices Can Add-or Take Away-Minutes ...

Eating more fruits, vegetables, and nuts can make a meaningful impact on a person's health—and the planet's too.

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

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 ...