Protein Supplementation for Breast Cancer

(NeoChemoPRT Trial)

Overseen By Clinical Trials Contact

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Disqualifiers: Severe arthritis, Cardiovascular, Lactose intolerance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is whey protein supplementation safe for humans?

Whey protein supplementation is generally considered safe for humans, as studies have shown it can improve body composition, muscle strength, and reduce postoperative complications in cancer patients. However, more clinical trials are needed to fully understand its safety and effects as an addition to cancer therapy. ^{1 2 3 4 5}

How does protein supplementation differ from other treatments for breast cancer?

Protein supplementation, specifically with α-lactalbumin (a component of whey protein), is unique because it may delay tumor development and reduce tumor incidence and size in breast cancer, as shown in animal studies. This approach is different from traditional treatments as it focuses on dietary intervention rather than pharmacological methods. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Whey Protein for breast cancer?

Research suggests that whey protein can improve nutritional status, boost immune function, and increase glutathione levels in cancer patients undergoing chemotherapy, which may help manage side effects and improve overall health. Additionally, higher protein intake has been associated with better breast cancer survival, indicating potential benefits of whey protein supplementation. ^{1 2 9 10 11}

Who Is on the Research Team?

Colin Champ, MD

Principal Investigator

AHN Radiation Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am between 20 and 89 years old.

I have been diagnosed with invasive breast cancer.

Exclusion Criteria

I am male.

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

Lactose intolerance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy as part of the treatment regimen

24 weeks

Exercise and Nutrition Intervention

Participants engage in high-load resistance training and receive post-workout protein supplementation

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whey Protein

Trial Overview 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.

How Is the Trial Designed?

Group I: 60 grams of protein Experimental Treatment 1 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 protein Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

52

Recruited

13,000+

Published Research Related to This Trial

In a study of 47 colorectal cancer patients undergoing chemotherapy, those who consumed whey protein showed a significant increase in lean body mass and a reduction in sarcopenia compared to those on a placebo.

Whey protein intake was associated with a better nutritional status and significantly lower rates of chemotherapy-related toxicity, suggesting it could be a valuable intervention to enhance patient outcomes during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study. Mazzuca, F., Roberto, M., Arrivi, G., et al.[2020]

Whey protein, particularly its subfractions like alpha-lactalbumin and lactoferrin, shows potential anti-cancer effects in laboratory studies, but these benefits have not been clearly observed in clinical practice.

Whey protein supplementation may help manage cancer cachexia syndrome, providing a practical and cost-effective strategy to support muscle health during cancer treatment, though further clinical trials are needed to confirm its efficacy as an adjunct therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey protein in cancer therapy: A narrative review. Teixeira, FJ., Santos, HO., Howell, SL., et al.[2020]

In a study of 42 cancer patients undergoing chemotherapy, whey protein supplementation significantly improved nutritional status, increasing albumin and immunoglobulin G levels compared to a control group.

The intervention group also experienced a notable increase in glutathione levels, suggesting that whey protein can enhance immune function and help prevent malnutrition during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey Protein Supplementation Improves Nutritional Status, Glutathione Levels, and Immune Function in Cancer Patients: A Randomized, Double-Blind Controlled Trial. Bumrungpert, A., Pavadhgul, P., Nunthanawanich, P., et al.[2018]

A humanized whey protein concentrate called IMMUNOCAL showed selective inhibitory effects on the growth of mammary carcinoma cells and Jurkat T cells, while sparing normal peripheral blood mononuclear cells.

The mechanism behind this selective inhibition is linked to a depletion of intracellular glutathione synthesis, suggesting that IMMUNOCAL could be a beneficial food supplement in conjunction with adjuvant chemotherapy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro selective modulation of cellular glutathione by a humanized native milk protein isolate in normal cells and rat mammary carcinoma model. Baruchel, S., Viau, G.[2015]

In a study of 6,348 women with stage I to III breast cancer, higher protein intake was associated with a modest improvement in survival rates, particularly with animal protein, suggesting that protein consumption may be beneficial post-diagnosis.

The study found no significant differences in survival benefits based on insulin receptor status or specific types of amino acids, indicating that women with breast cancer may not need to restrict protein intake for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein Intake and Breast Cancer Survival in the Nurses' Health Study. Holmes, MD., Wang, J., Hankinson, SE., et al.[2019]

In a study involving female rats, dietary α-lactalbumin significantly delayed breast cancer development compared to casein, with fewer tumors detected in the α-lactalbumin group after 130 days.

The α-lactalbumin group not only had a lower incidence and volume of tumors but also predominantly developed lower-grade tumors (grade I), indicating a potential protective effect against more aggressive cancer forms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection Against Dimethylbenz[a] Anthracene-Induced Breast Cancer in Female Rats by α-Lactalbumin. Roy, SS., Mukherjee, S., Ballard, BR., et al.[2021]

In a study of 166 malnourished advanced cancer patients undergoing chemotherapy, those who received 20g/day of whey protein isolate (WPI) along with nutritional counseling showed significant improvements in body composition and muscle strength compared to those who only received counseling.

WPI supplementation also reduced the risk of chemotherapy-related toxicity, particularly severe events, indicating that it may enhance the safety and efficacy of nutritional support during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey protein isolate supplementation improves body composition, muscle strength, and treatment tolerance in malnourished advanced cancer patients undergoing chemotherapy. Cereda, E., Turri, A., Klersy, C., et al.[2021]

Whey protein supplementation significantly reduced postoperative complications in cancer patients, with complications occurring in 22% of those supplemented compared to 32% in the control group, based on a meta-analysis of 10 trials involving 643 patients.

Patients who received whey protein showed improved functional walking capacity both before surgery and four weeks post-surgery, indicating enhanced physical recovery, although there were no significant differences in length of stay or thirty-day readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Whey Protein Supplementation on Perioperative Outcomes in Patients with Cancer-A Systematic Review and Meta-Analysis (PROSPERO 2020: CRD42020188666). Srinivasaraghavan, N., Das, N., Balakrishnan, K., et al.[2022]

In a study involving female Sprague Dawley rats, diets rich in soy protein isolate reduced the incidence of chemically induced mammary tumors by approximately 20% compared to casein, indicating a protective effect.

Bovine whey protein was found to be even more effective, reducing both the incidence and multiplicity of tumors by 54-62%, suggesting it may offer greater protective benefits against mammary tumors than soy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diets containing whey proteins or soy protein isolate protect against 7,12-dimethylbenz(a)anthracene-induced mammary tumors in female rats. Hakkak, R., Korourian, S., Shelnutt, SR., et al.[2015]

Whey protein hydrolysate (WPH) diets significantly reduced tumor incidence in DMBA-treated Sprague-Dawley rats compared to casein (CAS) diets, indicating a potential protective effect against cancer.

WPH diets promoted mammary gland differentiation and increased apoptosis while decreasing cell proliferation, which may be linked to higher levels of the tumor suppressor PTEN during early development, suggesting a mechanism for the observed cancer protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary exposure to whey proteins alters rat mammary gland proliferation, apoptosis, and gene expression during postnatal development. Eason, RR., Velarde, MC., Chatman, L., et al.[2023]

Young adult female Sprague-Dawley rats fed a diet with whey protein hydrolysate (WPH) showed lower levels of activated Tp53 and reduced DNA damage repair gene expression compared to those fed casein (CAS), suggesting that WPH may offer better protection against DNA damage in mammary cells.

Serum from WPH-fed rats exhibited greater apoptotic activity against MCF-7 tumor cells and higher levels of monocyte chemoattractant protein (MCP)-1, indicating that MCP-1 could serve as a biomarker for the beneficial effects of diets rich in whey protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tp53-associated growth arrest and DNA damage repair gene expression is attenuated in mammary epithelial cells of rats fed whey proteins. Dave, B., Eason, RR., Geng, Y., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Whey protein in cancer therapy: A narrative review. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Whey Protein Supplementation Improves Nutritional Status, Glutathione Levels, and Immune Function in Cancer Patients: A Randomized, Double-Blind Controlled Trial. [2018]

4. Greece pubmed.ncbi.nlm.nih.gov

In vitro selective modulation of cellular glutathione by a humanized native milk protein isolate in normal cells and rat mammary carcinoma model. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Protein Intake and Breast Cancer Survival in the Nurses' Health Study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Protection Against Dimethylbenz[a] Anthracene-Induced Breast Cancer in Female Rats by α-Lactalbumin. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Whey protein isolate supplementation improves body composition, muscle strength, and treatment tolerance in malnourished advanced cancer patients undergoing chemotherapy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Whey Protein Supplementation on Perioperative Outcomes in Patients with Cancer-A Systematic Review and Meta-Analysis (PROSPERO 2020: CRD42020188666). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Diets containing whey proteins or soy protein isolate protect against 7,12-dimethylbenz(a)anthracene-induced mammary tumors in female rats. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Dietary exposure to whey proteins alters rat mammary gland proliferation, apoptosis, and gene expression during postnatal development. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Tp53-associated growth arrest and DNA damage repair gene expression is attenuated in mammary epithelial cells of rats fed whey proteins. [2023]