Pea Protein Supplement for Head and Neck Cancer
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation Treatment
Participants receive chemoradiation therapy along with Kate Farms pea protein oral nutrition supplement during mealtimes
Post-Treatment Nutrition Support
Participants continue to receive Kate Farms pea protein oral nutrition supplement up to 1 month following chemoradiation
Follow-up
Participants are monitored for safety, effectiveness, and quality of life outcomes
Treatment Details
Interventions
- Kate Farms Standard 1.4 and/or Standard 1.0
Kate Farms Standard 1.4 and/or Standard 1.0 is already approved in United States for the following indications:
- 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
Kate Farms Inc
Industry Sponsor
Kate Farms, Inc.
Collaborator