60 Participants Needed

Pea Protein Supplement for Head and Neck Cancer

VB
JH
Overseen ByJackie Hernandez
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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.

What data supports the effectiveness of the treatment Kate Farms Standard 1.4 and/or Standard 1.0 for head and neck cancer?

Research on similar nutritional supplements, like those with omega-3 fatty acids, shows they can help stabilize weight and improve nutritional health in head and neck cancer patients. This suggests that nutritional support, like the Kate Farms supplements, might also be beneficial in managing weight and nutrition during cancer treatment.12345

How is the pea protein supplement treatment for head and neck cancer different from other treatments?

The pea protein supplement treatment, using Kate Farms Standard 1.4 and 1.0, is unique because it focuses on nutritional support, which may help maintain body weight and improve overall nutrition during cancer treatment. Unlike other treatments that may focus on direct cancer-fighting properties, this approach emphasizes the importance of nutrition in managing side effects and supporting recovery.14678

What is the purpose of this trial?

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 source of nutrition in reducing the gastrostomy tube placement rate in patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and who are undergoing chemoradiation therapy. Gastrostomy tube (G-tube) placement can be used for enteral feedings and may lead to long term side effects such as swallowing dysfunction and lead to higher rates of permanent G-tube dependence. The Kate Farms pea protein oral nutrition supplement is formulated with organic, planted-based protein for easier digestibility without artificial sweeteners or additives and without common allergens such as dairy, soy, gluten or corn. It is nutritionally complete, calorie and protein dense and available in multiple flavors that can be consumed directly or as a base for other recipes. Giving pea protein oral nutrition supplement may provide nutritional support to decrease the need for therapeutic G-tube rate during chemoradiation compared to standard supportive care.

Research Team

JD

Jie Deng

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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.
See 8 more

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
I refuse to use Kate Farms meal replacement due to its taste or my personal preferences.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Supportive care (pea protein oral nutrition supplement)Experimental Treatment3 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

Find a Clinic Near You

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+

Findings from Research

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).
[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 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.
[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 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.
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]

References

[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]. [2019]
[Head and neck cancer patients included at home enteral nutrition by tube]. [2013]
Nutrition outcomes following implementation of validated swallowing and nutrition guidelines for patients with head and neck cancer. [2022]
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. [2013]
A randomized clinical trial with two omega 3 fatty acid enhanced oral supplements in head and neck cancer ambulatory patients. [2008]
Recommended European Society of Parenteral and Enteral Nutrition protein and energy intakes and weight loss in patients with head and neck cancer. [2018]
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. [2021]
Tuna trimmings (Thunnas albacares) hydrolysate alleviates immune stress and intestinal mucosal injury during chemotherapy on mice and identification of potentially active peptides. [2023]
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