NCT05115760Active, not recruiting
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
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
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 14 May 2021
- Start date
- 5 Apr 2022
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT05115760
What you commit to
- Study type: Interventional
- Participants enrolled: 57
- From 5 Apr 2022 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation
Other illness
- Patients with allergies to any of the ingredients contained in Kate Farms nutritional replacement
Other
- Patients who refuse to use Kate Farms oral nutritional meal replacement due to its taste or other patient preference reasons
- Refusal to sign the informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California at Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.