Locally Advanced Head and Neck CarcinomaNCT05115760
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 study testing Dietary Supplement, Quality-of-Life Assessment and Questionnaire Administration in people with Locally Advanced Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Carcinoma
- What is being tested?
- Dietary Supplement, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Patients who refuse to use Kate Farms oral nutritional meal replacement due to its taste or other patient preference reasons
- Patients with allergies to any of the ingredients contained in Kate Farms nutritional replacement
- Evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation
- Refusal to sign the informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Los Angeles
Los Angeles, California, 90095
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the therapeutic G-tube placement rate during chemoradiation.
SECONDARY OBJECTIVES:
- To determine percent weight change during and following treatment. II. To determine body mass index (BMI) changes during and following treatment. III. To determine changes in nutrition status based on Global Leadership Initiative on Malnutrition (GLIM) criteria IV. To determine lean body mass before and after treatment via psoas muscle surrogate measurement on routine staging scans.
- To determine the adherence rate of Kate Farms oral nutritional replacement. VI. To determine changes in oral and gastrointestinal microbiota via 16s ribosomal ribonucleic acid (RNA) sequencing during and following treatment in an exploratory analysis.
VII. To determine changes in biomarkers during treatment. VIIa. Serum human papillomavirus (HPV) deoxyribonucleic (DNA). VIIb. 38-multiplex immune cytokine and chemokine panel in an exploratory analysis.
VIIc. Complete metabolic panel, complete blood count with differential, C-reactive protein (CRP).
VIId. Radiosensitivity germ-line biomarker panel. VIII. To determine physician-reported acute and late toxicities during and following treatment.
VIIIa. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. IX. To determine patient-reported quality of life during and following treatment.
IXa. University of Washington and Functional Assessment of Cancer Therapy questionnaires.
IXb. Functional Assessment of Cancer Therapy-Head \& Neck (FACT-H\&N). X. To determine clinical outcomes from treatment. Xa. Local/Locoregional control. Xb. Distant metastasis-free survival. Xc. Overall survival.
OUTLINE:
Patients receive Kate Farms pea protein oral nutrition supplement orally (PO) during their mealtimes as directed by their clinical dietitian during and up to 1 month following chemoradiation in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up for a minimum of 2 years.
- Conditions
- Locally Advanced Head and Neck Carcinoma
- Being tested
- Dietary Supplement, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDietary supplement
Also called Dietary Supplements, Nutritional Supplement, Supplement, supplemental nutrition
Given Kate Farms pea protein oral nutrition supplement PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (pea protein oral nutrition supplement) | Experimental | 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. Receives: Dietary Supplement: Dietary Supplement; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate
Will calculate the compliance rate and the corresponding 95% exact confidence interval.
Measured: Up to 1 month post chemoradiation
Gastrostomy (G)-tube placement rate
Will calculate the compliance rate and the corresponding 95% exact confidence interval. The 95% exact confidence interval (CI) will be provided.
Measured: Up to 1 month post chemoradiation
Secondary outcomes (9)
Weight change measurement
Weight data will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure analysis of variance (ANOVA) will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.
Measured: Up to 2 years
Body mass index change measurement (BMI)
BMI data will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure ANOVA will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.
Measured: Up to 2 years
Global Leadership Initiative on Malnutrition criteria
Will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure ANOVA will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.
Measured: Up to 2 years
Patient-reported quality of life (QOL): The University of Washington Quality of Life Questionnaire (UW-QOL).
Patient-reported QOL according to the University of Washington (UW-QOL) questionnaires will be summarized by descriptive statistics by visit time points.
The University of Washington Quality of Life Questionnaire (UW-QOL) is a self-administered scale measuring health-related quality life specifically for head and neck cancer patients. It is scored from 0-100 with higher scores indicating a better quality of life.
Measured: Up to 2 years
Patient-reported quality of life (QOL): The Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN).
Patient-reported QOL according to the Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) questionnaires will be summarized by descriptive statistics by visit time points.
Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) is a 12 item self-administered scale measuring health-related quality of life specifically for head and neck cancer patients. Response options form a Likert scale and a subscale score is computed by summing across all items, with higher scores reflecting better QOL.
Measured: Up to 2 years
Local/locoregional control
Will be estimated using the Kaplan-Meier method.
Measured: Up to 2 years
Distant metastasis-free survival
Will be estimated using the Kaplan-Meier method.
Measured: Up to 2 years
Overall survival
Will be estimated using the Kaplan-Meier method.
Measured: Up to 2 years
Incidence of adverse events (AEs)
Toxicity will be graded using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version (v) 4.0. AEs and serious (S)AEs will be reported using a CTCAE v 4.0 terminology and severity.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start5 Apr 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kate Farms Inc
- Responsible party
- Sponsor
- Investigators
- Jie Deng, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115760
- Sponsor's protocol ID
- 20-002182
- Other IDs
- NCI-2021-03612
- Status last verified
- Mar 2026
- First submitted
- 14 May 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05115760
- Acronym / sponsor ID
- 20-002182
- Conditions
- Locally Advanced Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Kate Farms Inc
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the therapeutic G-tube placement rate during chemoradiation.
SECONDARY OBJECTIVES:
- To determine percent weight change during and following treatment. II. To determine body mass index (BMI) changes during and following treatment. III. To determine changes in nutrition status based on Global Leadership Initiative on Malnutrition (GLIM) criteria IV. To determine lean body mass before and after treatment via psoas muscle surrogate measurement on routine staging scans.
- To determine the adherence rate of Kate Farms oral nutritional replacement. VI. To determine changes in oral and gastrointestinal microbiota via 16s ribosomal ribonucleic acid (RNA) sequencing during and following treatment in an exploratory analysis.
VII. To determine changes in biomarkers during treatment. VIIa. Serum human papillomavirus (HPV) deoxyribonucleic (DNA). VIIb. 38-multiplex immune cytokine and chemokine panel in an exploratory analysis.
VIIc. Complete metabolic panel, complete blood count with differential, C-reactive protein (CRP).
VIId. Radiosensitivity germ-line biomarker panel. VIII. To determine physician-reported acute and late toxicities during and following treatment.
VIIIa. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. IX. To determine patient-reported quality of life during and following treatment.
IXa. University of Washington and Functional Assessment of Cancer Therapy questionnaires.
IXb. Functional Assessment of Cancer Therapy-Head \& Neck (FACT-H\&N). X. To determine clinical outcomes from treatment. Xa. Local/Locoregional control. Xb. Distant metastasis-free survival. Xc. Overall survival.
OUTLINE:
Patients receive Kate Farms pea protein oral nutrition supplement orally (PO) during their mealtimes as directed by their clinical dietitian during and up to 1 month following chemoradiation in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up for a minimum of 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (pea protein oral nutrition supplement) | Experimental | Dietary Supplement: Dietary Supplement, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (4 listed)
- Patients who refuse to use Kate Farms oral nutritional meal replacement due to its taste or other patient preference reasons
- Patients with allergies to any of the ingredients contained in Kate Farms nutritional replacement
- Evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation
- Refusal to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary SupplementAlso: Dietary Supplements, Nutritional Supplement, Supplement, supplemental nutritionGiven Kate Farms pea protein oral nutrition supplement PO | Dietary supplement | Supportive care (pea protein oral nutrition supplement) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (pea protein oral nutrition supplement) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (pea protein oral nutrition supplement) |
Primary outcome
Compliance rate
Time frame: Up to 1 month post chemoradiation
Will calculate the compliance rate and the corresponding 95% exact confidence interval.
Gastrostomy (G)-tube placement rate
Time frame: Up to 1 month post chemoradiation
Will calculate the compliance rate and the corresponding 95% exact confidence interval. The 95% exact confidence interval (CI) will be provided.
9 secondary outcomes
Weight change measurement
Time frame: Up to 2 years
Body mass index change measurement (BMI)
Time frame: Up to 2 years
Global Leadership Initiative on Malnutrition criteria
Time frame: Up to 2 years
Patient-reported quality of life (QOL): The University of Washington Quality of Life Questionnaire (UW-QOL).
Time frame: Up to 2 years
Patient-reported quality of life (QOL): The Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN).
Time frame: Up to 2 years
Local/locoregional control
Time frame: Up to 2 years
Distant metastasis-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Incidence of adverse events (AEs)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Deng principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement, Quality-of-Life Assessment and Questionnaire Administration in people with Locally Advanced Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate (time frame: Up to 1 month post chemoradiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.