RECRUITING

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

Talk to us

Conditions

Locally Advanced Head and Neck Carcinoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-04-05
Study Completion:2027-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05115760

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented locally advanced head and neck malignancies for which concurrent chemoradiation has been recommended for definitive or adjuvant treatment
  2. * Age \>= 18 years
  3. * Eastern Cooperative Oncology Group (ECOG) \<= 2
  4. * Body mass index \> 18kg/m\^2
  5. * No evidence of distant metastatic disease (M1 disease)
  6. * No G-tube placement prior to initiation of chemoradiation
  7. * Eligible to undergo concurrent chemotherapy as determined by treating oncologist
  8. * 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
  9. * 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.
  10. * Ability to understand and willingness to sign a written informed consent
  11. * Able to tolerate the taste of the Kate Farms Standard 1.4 or Standard 1.0 oral nutritional supplement at the time of screening
  12. * Able and willing to participate in the Swallow Preservation Program at the Speech Pathology Clinic
  13. * No evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation
  1. * Patients who refuse to use Kate Farms oral nutritional meal replacement due to its taste or other patient preference reasons
  2. * Patients with allergies to any of the ingredients contained in Kate Farms nutritional replacement
  3. * Evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation
  4. * Refusal to sign the informed consent

Contacts and Locations

Study Contact

Vincent Basehart
CONTACT
310 267-8954
vbasehart@mednet.ucla.edu
Jackie Hernandez
CONTACT
310 206-8477
jhernandez@mednet.ucla.edu

Principal Investigator

Jie Deng
PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

University of California at Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Jie Deng, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-05
Study Completion Date2027-06-01

Study Record Updates

Study Start Date2022-04-05
Study Completion Date2027-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Head and Neck Carcinoma