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Protein Supplementation for Breast Cancer (NeoChemoPRT Trial)

Pittsburgh, PA

N/A

Recruiting

Led By Colin Champ, MD

Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 not have

Males

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at program completion (at 24 weeks)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if giving cancer patients a high dose of protein after workouts and a specific exercise plan can help improve their body composition and physical abilities."

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Who is the study for?

This trial is for women aged 20-89 with invasive breast cancer who are undergoing neoadjuvant chemotherapy before surgery. Participants must be able to perform physical exercises, read and understand English, and consent for themselves. It excludes those with severe health conditions that prevent exercise, lactose intolerance, allergies to cow's milk or whey protein, as well as pregnant women and males.Check my eligibility

What is being tested?

The study tests if high-load resistance training combined with a high dose of post-workout whey protein (either 20 grams or 60 grams) can improve body composition and functional capacity in women receiving chemotherapy for breast cancer.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort due to the whey protein intake, especially in individuals sensitive to dairy products. The resistance training could cause muscle soreness or injury if not performed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with invasive breast cancer.

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I am a woman receiving chemotherapy before breast surgery.

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I am between 20 and 89 years old.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am male.

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I cannot squat or get up from the ground by myself.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at program completion (at 24 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at program completion (at 24 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at program completion (at 24 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Changes in Functional Mobility Score at baseline and at completion of chemotherapy

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

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 60 grams of proteinExperimental Treatment1 Intervention

Participants will be randomized (like flipping a coin) to a post-workout protein consisting of 60 grams of whey protein. The protein will be 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy, which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Participants will not know which amount of protein they receive.

Group II: 20 grams of proteinExperimental Treatment1 Intervention

Participants will be randomized (like flipping a coin) to a post-workout protein consisting of 20 grams of whey protein. The protein will be 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy, which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Participants will not know which amount of protein they receive.

0 / 5Eligibility criteria met