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NCT05115760 · ClinicalTrials.gov registry record · NA
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
A NA study of Locally Advanced Head and Neck Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT05115760: Active NA study of Locally Advanced Head and Neck Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
NCT05115760 is a NA study of Locally Advanced Head and Neck Carcinoma that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05115760, a NA study of Locally Advanced Head and Neck Carcinoma, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Will calculate the compliance rate and the corresponding 95% exact confidence interval.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DIETARY_SUPPLEMENT Dietary Supplement
Study Locations (1)
California
- University of California at Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2022-04-05 |
| Est. Completion | 2027-06-01 |
| Phase | NA |
What the registry record for NCT05115760 still lists
NCT05115760 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Locally Advanced Head and Neck Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05115760 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05115760 about?
NCT05115760 is a clinical study titled "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". 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 (loca...
What is the current status of trial NCT05115760?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 57 participants. The study started on 2022-04-05. Estimated completion is 2027-06-01.
What conditions does trial NCT05115760 study?
This clinical trial studies the following conditions: Locally Advanced Head and Neck Carcinoma.
What interventions are being tested in trial NCT05115760?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Dietary Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05115760?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05115760 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05115760's enrollment target sits among peer trials
57 1261st of 2000 higher than 739 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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