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

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Nov 1, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at whether a plant-based oral nutrition supplement called Kate Farms can help reduce the need for feeding tubes in patients with locally advanced head and neck cancer who are undergoing chemoradiation therapy. Feeding tubes, also known as gastrostomy tubes, are sometimes necessary for patients who have difficulty swallowing, but they can lead to long-term issues. The Kate Farms supplement is designed to provide complete nutrition in a form that is easy to digest and free from common allergens like dairy and gluten.

To be eligible for this trial, participants should be adults aged 18 or older with locally advanced head and neck cancer, and they must not have had a feeding tube placed before starting treatment. They'll also need to agree to participate in a special program to help preserve their swallowing ability. If you or a loved one are considering joining this trial, you can expect to receive nutritional support through the Kate Farms supplement, and you’ll have the opportunity to help researchers learn more about improving care for patients in similar situations.

Gender

ALL

Eligibility criteria

• 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 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