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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05115760
The ClinicalTrials.gov registry entry for NCT05115760 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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