Pea protein nutrition supplement to reduce feeding tube placement in head and neck cancer patients
Intervention With Pea Protein Oral Nutrition Supplement Meal Replacement to Reduce Therapeutic Gastrostomy Tube Rates in Patients With Head and Neck Cancer Undergoing Chemoradiation Therapy
This study is testing if a plant-based nutrition supplement can help people with head and neck cancer avoid needing feeding tubes during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05115760 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a plant-based oral nutrition supplement, specifically Kate Farms Standard 1.4 and/or Standard 1.0, on reducing the need for gastrostomy tube placement in patients with locally advanced head and neck cancer undergoing chemoradiation therapy. The study aims to assess various outcomes, including weight change, body mass index, nutritional status, and quality of life, while also exploring changes in microbiota and biomarkers. Participants will receive the supplement as their primary source of nutrition during treatment, with the goal of minimizing long-term complications associated with feeding tubes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with locally advanced head and neck malignancies who are eligible for concurrent chemoradiation and have not previously required a gastrostomy tube.
Not a fit: Patients with distant metastatic disease or those who have already had a gastrostomy tube placed prior to treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for feeding tubes and improve the quality of life for patients undergoing treatment for head and neck cancer.
How similar studies have performed: While the specific use of pea protein supplements in this context may be novel, similar studies exploring nutritional interventions in cancer care have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented locally advanced head and neck malignancies for which concurrent chemoradiation has been recommended for definitive or adjuvant treatment * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) \<= 2 * Body mass index \> 18kg/m\^2 * No evidence of distant metastatic disease (M1 disease) * No G-tube placement prior to initiation of chemoradiation * Eligible to undergo concurrent chemotherapy as determined by treating oncologist * If a woman is of childbearing potential, a negative urine pregnancy test must be documented prior to proceeding with chemoradiation. Women of childbearing potential must agree to use medically acceptable forms of adequate contraception (hormonal or barrier method of birth control; or abstinence) for the entire study period and for up to 4 weeks after study treatment * While negative pregnancy would be verified by urine test routinely prior to chemo-radiation therapy, we do not ask for verification of a negative urine pregnancy test. * Ability to understand and willingness to sign a written informed consent * Able to tolerate the taste of the Kate Farms Standard 1.4 or Standard 1.0 oral nutritional supplement at the time of screening * Able and willing to participate in the Swallow Preservation Program at the Speech Pathology Clinic * No evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation Exclusion Criteria: * Patients who refuse to use Kate Farms oral nutritional meal replacement due to its taste or other patient preference reasons * Patients with allergies to any of the ingredients contained in Kate Farms nutritional replacement * Evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation * Refusal to sign the informed consent
Where this trial is running
Los Angeles, California
- University of California at Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jie Deng — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Vincent Basehart
- Email: vbasehart@mednet.ucla.edu
- Phone: 310 267-8954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.