EXERT-BC Protein: Protein Supplementation to Improve Body Composition After Treatment for Breast Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-89
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

About this trial

In this study, the investigators hypothesize that a high dose of post-workout protein after each exercise session will have greater improvements in changes in body composition, including muscle mass and percent body fat versus a workout alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-89 years

Women prescribed exercise as a SOC

Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast

Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.

Disqualifiers

Any current treatment with cytotoxic chemotherapy for breast cancer

Inability to safely engage in group sessions of resistance training as deemed by study PI

Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training

Beta blocker or GLP-1 inhibitor medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Whey protein (60 grams)

    Dietary supplement

    60 grams of whey protein

  • No protein

    Other intervention

    0 grams of whey protein

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: 60 grams of proteinExperimental treatment 1 intervention
Group B: 0 grams of proteinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine changes in pounds of muscle and fat mass after each exercise regimen

Time frame
Baseline and at program completion (within 4 weeks of exercise completion)

Secondary outcomes

1

Determine changes in resting metabolic rate in calories per day at the completion of the exercise regimen

Time frame
Baseline and at program completion (within 4 weeks of exercise completion)
2

Determine changes in body composition at the completion of the exercise regimen, including body mass in pounds, fat mass in pounds, fat-free mass in pounds, % fat, and % fat-free mass

Time frame
Baseline and at program completion (within 4 weeks of exercise completion)
3

Determine changes in Y-balance score at the completion of the exercise regimen

Y-Balance score measures the length an individual can extend their foot. The larger the score the better the balance.

Time frame
Baseline and at program completion (within 4 weeks of exercise completion)
4

Functional Movement Screen (FMS) scores at the completion of the exercise regimen

FMS measures movement patterns with scoring from 0 to 21. The large the score the better the mobility.

Time frame
Baseline and at program completion (within 4 weeks of exercise completion)

Other outcomes

Sponsors and contacts

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