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Dietary Supplement

Pea Protein Supplement for Head and Neck Cancer

N/A

Recruiting

Led By Jie Deng

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented locally advanced head and neck malignancies for which concurrent chemoradiation has been recommended for definitive or adjuvant treatment

No G-tube placement prior to initiation of chemoradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is studying the effect of a plant-based oral nutrition supplement on reducing the gastrostomy tube placement rate in patients with head and neck cancer undergoing chemoradiation therapy.

Who is the study for?

This trial is for adults over 18 with locally advanced head and neck cancer who are undergoing chemoradiation but don't yet have a gastrostomy tube or significant swallowing issues. They must be able to tolerate the taste of Kate Farms pea protein supplement, maintain a body mass index above 18kg/m^2, and women must use contraception if applicable.Check my eligibility

What is being tested?

The study tests whether using Kate Farms Standard 1.4 or Standard 1.0 pea protein supplements as primary nutrition can reduce the need for gastrostomy tubes in patients during chemoradiation therapy compared to standard care.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include digestive discomfort due to dietary changes from consuming the pea protein supplement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My head or neck cancer is advanced and needs combined chemotherapy and radiation.

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I have not had a G-tube placed before starting chemoradiation.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am 18 years old or older.

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I don't have trouble swallowing based on my recent exams.

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My cancer has not spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compliance rate

Gastrostomy (G)-tube placement rate

Secondary outcome measures

Body mass index change measurement (BMI)

Distant metastasis-free survival

Global Leadership Initiative on Malnutrition criteria

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (pea protein oral nutrition supplement)Experimental Treatment3 Interventions

Patients receive Kate Farms pea protein oral nutrition supplement PO during their mealtimes as directed by their clinical dietitian during and up to 1 month following chemoradiation in the absence of unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Supplement

2022

Completed Phase 2

~250

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kate Farms IncIndustry Sponsor

Jonsson Comprehensive Cancer CenterLead Sponsor

360 Previous Clinical Trials

27,652 Total Patients Enrolled

Kate Farms, Inc.UNKNOWN

Media Library

Kate Farms Standard 1.4 and/or Standard 1.0 (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05115760 — N/A

Head and Neck Cancers Research Study Groups: Supportive care (pea protein oral nutrition supplement)

Head and Neck Cancers Clinical Trial 2023: Kate Farms Standard 1.4 and/or Standard 1.0 Highlights & Side Effects. Trial Name: NCT05115760 — N/A

Kate Farms Standard 1.4 and/or Standard 1.0 (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05115760 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this scientific investigation currently taking place?

"Affirmative. Clinicaltrials.gov attests that this clinical trial is currently in search of participants, with the original posting having been made on June 15th 2021 and most recently updated on March 23rd 2022. The research aims to recruit 60 people across a single medical centre."

Answered by AI

What is the aggregate tally of individuals taking part in this investigation?

"Affirmative, the clinicaltrials.gov website confirms that this trial is still recruiting participants. It was initially posted on June 15th 2021 and recently updated on March 23rd 2022. 60 individuals are being sought from 1 medical centre for this investigation."

Answered by AI

What is the principal objective of this clinical investigation?

"Across 1 month post-chemoradiation, this clinical trial will assess patient compliance rate as the primary outcome. As secondary outcomes, Distant metastasis-free survival, Overall Survival and changes in Body Mass Index (BMI) will be evaluated using Kaplan Meier Methodology and repeated measure ANOVA respectively. Additionally, G-tube placement timing together with duration of dependence per study participant are also being recorded for data summarization."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05115760.