Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy 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 nutrition regimen focused on food quality and an observed exercise regimen utilizing high-load resistance training initiated during or after cancer treatment will improve body composition and functional capacity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-89 years

Women with a biopsy proven diagnosis of invasive carcinoma of the breast.

Women must undergo neoadjuvant chemotherapy for breast cancer treatment prior to surgery

Must be able to read and understand English and consent for themselves.

Disqualifiers

Inability to get up and down off the ground or squat body weight

Inability to safely engage in group exercise sessions as deemed by study PI

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

Lactose intolerance

Trial design

Design model

Parallel

Treatments tested in this trial

  • Whey protein (20 grams)

    Dietary supplement

    20 grams of whey protein

  • Whey protein (60 grams)

    Dietary supplement

    60 grams of whey protein.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: 20 grams of proteinExperimental treatment 1 intervention
Group B: 60 grams of proteinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in muscle mass and fat mass (pounds) at completion of chemotherapy

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

Secondary outcomes

1

Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST)

Response to chemotherapy will be assessed via the guidelines or the Response evaluation criteria in solid tumors (RECIST) criteria version 1.1 before and after chemotherapy with radiographic interpretation on either MRI of the breast or, if unable to get an MRI, PET/CT scan.

Time frame
Chemotherapy response assessment is at program completion (within 4 weeks of exercise completion)
2

Changes in EuroQol-5 Dimensions (EQ-5D) at completion of chemotherapy assessment

EuroQol-5 Dimensions-5 Levels total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). This is calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of "no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"/"unable to", respectively. Higher scores mean worse outcomes.

Time frame
Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
3

Changes in Patient Health Questionnaire-9 (PHQ9) depression score at completion of chemotherapy assessment

Patient Health Questionnaire-9 total score for the 9 questions ranges from 0 (no depression) to 27 (highest level of depression). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. Higher scores mean a worse outcome.

Time frame
Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
4

Changes in General Anxiety Disorder-7 (GAD7) anxiety score at completion of chemotherapy assessment

General Anxiety Disorder-7 total score for the seven questions ranges from 0 (no anxiety) to 21 (highest level of anxiety). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. Higher scores mean a worse outcome.

Time frame
Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).

Other outcomes

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