Pea Protein Oral Nutrition Supplement for the Reduction of Gastrostomy Tube Placement Rate in Pat… (NCT05115760) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
United States57 participantsStarted 2022-04-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.