A Phase II Study Integrating SoylentTM Meal Replacement to Reduce Gastrostomy Tube Rates in Patients
Clinical Trial: Food Supplement for Weight Maintenance
Use of Soylent Meal Replacement™ as a Way to Maintain Weight During Radiation Treatment
People who receive chemotherapy and radiation (“chemoradiation”) for the treatment of head and neck cancer often develop side effects which make eating and swallowing difficult and/or painful. In order to maintain their weight, these individuals maybe replace a number of their daily meals with commonly-used, liquid meal replacements such as Boost™ or Ensure™.
If a patient’s weight becomes too low, it is often recommended to have a gastrostomy tube (“g-tube”) temporarily placed until the patient can eat normally again. A g-tube is a tube which is surgically inserted into the stomach from the abdomen, which allows direct feeding of the patient to allow for proper nutrition.
The purpose of this research study is to assess whether the liquid meal replacement product Soylent™ may reduce the risk of malnutrition and need for g-tube placement during following treatment for head and neck cancer with chemoradiation. Soylent™ is a liquid meal replacement which is commonly used for nutrition.
Subjects will undergo routine chemoradiation and will be seen regularly by a clinical nutritionist to actively measure their weight and ability to eat and swallow. If a subject’s weight drops below 5% of their total body weight, they will begin taking Soylent™ multiple times a day for about 30 days, or until their body weight recovers or they can eat other food.
Subjects will be asked to complete regular quality of life questionnaires and return to the UCLA Department of Radiation Oncology for routine follow-up visits which include physical exams, about once every three months.
Eligibility Criteria (Basic):
- Must be 18 years of age or older.
- Must be planning to undergo routine chemoradiation for head and neck cancer.
- May not have already received radiation to the head and neck.
Other eligibility criteria exist.
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