Pea Protein Supplement for Head and Neck Cancer

Overseen By Jackie Hernandez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Allergies to ingredients, Swallowing dysfunction, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a plant-based pea protein supplement (Kate Farms Standard 1.4 and/or Standard 1.0) can reduce the need for gastrostomy tubes in individuals with locally advanced head and neck cancer undergoing chemoradiation. Kate Farms designed the supplement to be easy to digest and free from common allergens like dairy and gluten. Researchers aim to determine if this nutritional support can help patients maintain their nutrition without requiring a feeding tube. Suitable candidates for this trial include those with head and neck cancer recommended for chemoradiation, who do not currently have a feeding tube, and can tolerate the supplement's taste. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance nutritional care for future patients.

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

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with your doctor.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that Kate Farms' plant-based nutritional supplements, such as Standard 1.4 and Standard 1.0, prioritize safety. These supplements use organic pea protein and exclude common allergens like dairy, soy, gluten, and corn, making them easier to digest for many individuals.

Users of these supplements have not reported major safety issues. They are often used by individuals with health conditions such as cancer and Crohn's disease who require extra calories and nutrients, indicating they are generally well-tolerated.

Overall, these plant-based formulas aim to support nutrition without causing negative effects. For specific concerns, consulting a healthcare provider is recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kate Farms pea protein supplement because it offers a plant-based nutritional boost specifically designed for patients undergoing chemoradiation for head and neck cancer. Unlike traditional supplements that might contain animal-based proteins, this treatment uses pea protein, which is easier to digest and suitable for patients with dietary restrictions. Additionally, the supplement is designed to be taken during mealtimes, providing a convenient way to maintain nutrition and support recovery without adding extra stress to patients' routines.

What evidence suggests that this pea protein supplement is effective for reducing gastrostomy tube placement in head and neck cancer patients?

Research has shown that plant-based nutrition can improve treatment outcomes for cancer patients. In this trial, participants will receive Kate Farms Standard 1.4 and/or Standard 1.0, high-calorie shakes made from organic pea protein. These shakes are gentle on the stomach and can aid in weight gain. They do not contain common allergens like dairy, soy, or gluten. The shakes provide essential nutrients and calories, potentially reducing the need for a feeding tube during chemoradiation therapy for head and neck cancer patients. The aim is to offer nutritional support that may lower the risk of long-term side effects from feeding tubes, such as swallowing problems. ^{1 3 4 6 7}

Who Is on the Research Team?

Jie Deng

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with locally advanced head and neck cancer who are undergoing chemoradiation but don't yet have a gastrostomy tube or significant swallowing issues. They must be able to tolerate the taste of Kate Farms pea protein supplement, maintain a body mass index above 18kg/m^2, and women must use contraception if applicable.

Inclusion Criteria

My head or neck cancer is advanced and needs combined chemotherapy and radiation.

I am not pregnant and agree to use birth control during and 4 weeks after the study.

I have not had a G-tube placed before starting chemoradiation.

Exclusion Criteria

I have trouble swallowing that's noticeable by my doctor.

Patients with allergies to any of the ingredients contained in Kate Farms nutritional replacement

Refusal to sign the informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation Treatment

Participants receive chemoradiation therapy along with Kate Farms pea protein oral nutrition supplement during mealtimes

6-8 weeks

Weekly visits for monitoring

Post-Treatment Nutrition Support

Participants continue to receive Kate Farms pea protein oral nutrition supplement up to 1 month following chemoradiation

4 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes

Up to 2 years

Regular follow-up visits every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Kate Farms Standard 1.4 and/or Standard 1.0

Trial Overview The study tests whether using Kate Farms Standard 1.4 or Standard 1.0 pea protein supplements as primary nutrition can reduce the need for gastrostomy tubes in patients during chemoradiation therapy compared to standard care.

How Is the Trial Designed?

Group I: Supportive care (pea protein oral nutrition supplement) Experimental Treatment 3 Interventions

Patients receive Kate Farms pea protein oral nutrition supplement PO during their mealtimes as directed by their clinical dietitian during and up to 1 month following chemoradiation in the absence of unacceptable toxicity.

Kate Farms Standard 1.4 and/or Standard 1.0 is already approved in United States for the following indications:

Approved in United States as Kate Farms Standard 1.4 and/or Standard 1.0 for:

• Nutritional support for patients undergoing chemoradiation therapy for locally advanced head and neck cancer
• Support for patients with difficulty gaining or maintaining weight due to chronic diseases such as cancer, ALS, Crohn’s disease

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Kate Farms Inc

Industry Sponsor

Trials

1

Recruited

60+

Kate Farms, Inc.

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

In a study of 62 patients with head and neck cancer receiving home enteral nutrition (HEN) via feeding tubes, those who started HEN before radiotherapy maintained their Body Mass Index (BMI) and did not experience weight loss during treatment.

The main reason for initiating enteral nutrition was dysphagia, and the most common feeding method was through naso-gastric tubes, with patients receiving an average of 1,629 kcal/day from a polymeric hypercaloric diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Head and neck cancer patients included at home enteral nutrition by tube]. Cots Seignot, I., Cárdenas Lagranja, G., Puiggròs Llop, C., et al.[2013]

In a study of 65 post-surgical head and neck cancer patients, both omega-3 fatty acid enhanced diets improved serum protein levels, indicating better nutritional status after surgery.

Both diets were well-tolerated with similar rates of gastrointestinal issues and postoperative infections, suggesting that omega-3 supplementation is safe and effective for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial with two omega 3 fatty acid enhanced oral supplements in head and neck cancer ambulatory patients. de Luis, DA., Izaola, O., Aller, R., et al.[2008]

Tuna trimmings protein hydrolysate (TPA) significantly enhances the anti-tumor effects of 5-fluorouracil (5-FU) chemotherapy in S180 tumor-bearing mice, leading to a notable reduction in tumor volume with medium and high doses of TPA.

TPA also protects the intestinal mucosa during chemotherapy, as indicated by improved intestinal health markers and increased protein levels in the mice, suggesting it could be beneficial as nutritional support for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tuna trimmings (Thunnas albacares) hydrolysate alleviates immune stress and intestinal mucosal injury during chemotherapy on mice and identification of potentially active peptides. Zhao, X., Cai, B., Chen, H., et al.[2023]

In a study of 37 postsurgical head and neck cancer patients, an omega-3 fatty acid and arginine enhanced diet improved blood protein levels and lymphocyte counts, indicating better nutritional status.

Patients consuming a higher dose of the supplement (three cans per day) also experienced significant improvements in weight and body composition, while gastrointestinal tolerance was good with no reported complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial with two doses of a omega 3 fatty acids oral and arginine enhanced formula in clinical and biochemical parameters of head and neck cancer ambulatory patients. de Luis, DA., Izaola, O., Cuellar, L., et al.[2013]

In a study of 38 newly diagnosed head and neck cancer patients, those following the European Society of Parenteral and Enteral Nutrition (ESPEN) recommendations of ≥30 kcal/kg/d energy still experienced significant weight loss, averaging 10.3% from baseline to posttreatment.

Patients consuming oral nutrition supplements lost twice as much weight compared to those who did not, even when both groups met the energy intake recommendations, suggesting that current guidelines may not effectively prevent weight loss in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommended European Society of Parenteral and Enteral Nutrition protein and energy intakes and weight loss in patients with head and neck cancer. Giles, KH., Kubrak, C., Baracos, VE., et al.[2018]

In a study of 539 head and neck cancer patients, adherence to nutrition management guidelines was 81%, but significant weight loss (6% during treatment and 9% at 3 months post-treatment) was still observed, indicating that proactive interventions like gastrostomy tubes may not fully prevent malnutrition.

Non-adherence to nutrition guidelines was linked to increased weight loss, and patients with higher body mass index (BMI) had greater odds of losing weight, suggesting that tailored interventions based on individual risk factors are crucial for improving nutrition outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition outcomes following implementation of validated swallowing and nutrition guidelines for patients with head and neck cancer. Brown, T., Ross, L., Jones, L., et al.[2022]

In a study of 17 patients with oropharyngeal and hypopharyngeal cancer undergoing chemoradiotherapy, the nutritional supplement Prosure®, rich in omega-3 fatty acids, significantly reduced body weight loss compared to a historical control group (7.3% vs 10.3%, p<0.01).

Prosure® also led to a significant reduction in the incidence of severe oral mucositis (Grade 3-4) among patients, with rates of 24% in the Prosure® group compared to 58% in the control group (p<0.05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Nutritional Supplement with a High Blend Ratio of ω-3 Fatty Acids(Prosure®) Reduces Severe Oral Mucositis and Body Weight Loss for Head and Neck Cancer Patients Treated with Chemoradiotherapy]. Mizumachi, T., Kano, S., Homma, A., et al.[2019]

In a study involving 62 malnourished patients with head and neck cancer, an EPA-enriched nutritional supplement did not lead to significant changes in body weight or composition during the perioperative period.

The addition of EPA to nutritional supplements did not affect hospitalization duration or postoperative complications, suggesting that it may not provide additional benefits in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of EPA-enriched supplement compared with standard formula on body weight changes in malnourished patients with head and neck cancer undergone surgery: a randomized study. Jantharapattana, K., Orapipatpong, O.[2021]

Citations

1. shop.katefarms.com shop.katefarms.com/products/standard-1-4

Standard 1.4 Vanilla Kate Farms Standard 1.4 is a high-calorie shake with USDA Organic plant-based pea protein designed to help support weight gain.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05115760/pea-protein-oral-nutrition-supplement-for-the-reduction-of-gastrostomy-tube-placement-rate-in-patients-with-locally-advanced-head-and-neck-cancer-undergoing-chemoradiation-therapy

Pea Protein Oral Nutrition Supplement for the Reduction of ... This phase II trial studies the effect of a plant-based oral nutrition supplement, Kate Farms Standard 1.4 and/or Standard 1.0. as a primary ...

3. katefarms.com katefarms.com/resources/health-guides/nutrition-during-cancer/

Nutrition During Cancer For people in cancer treatment, fruits, vegetables, whole grains, lean proteins, healthy fats, and hydration support positive treatment outcomes and side ...

4. katefarmsmedical.com katefarmsmedical.com/products/standard-1-4-plain/

Standard 1.4 Plain Features · Made for Tolerance · Easily digested organic pea protein · Low osmolality that may support GI tolerance · Organic MCT oil for easy fat absorption.

5. katefarms.com katefarms.com/news-and-press/press-releases/improved-outcomes-for-pediatric-patients-with-kate-farms-plant-based-nutrition-formulas/

Kate Farms Releases New Clinical Study Demonstrating ... Kate Farms Releases New Clinical Study Demonstrating Improved Outcomes for Pediatric Patients when using the Company's Plant-Based Nutrition ...

6. shop.katefarms.com shop.katefarms.com/products/standard-1-0

Standard 1.0 Kate Farms Standard 1.0 has 27 essential vitamins and minerals, is made without common allergens, and provides 16 grams of organic pea protein. Certified ...

7. katefarms.com katefarms.com/news-and-press/press-releases/kate-farms-introduces-two-new-medical-nutrition-formulas-leading-the-way-for-plant-based-nutrition-in-healthcare/

Kate Farms Introduces Two New Medical Nutrition ... Kate Farms Standard 1.4 will be effective among patients with cancer, ALS, Crohn's disease, and other conditions who can benefit from calorie- ...