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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Compliance rate
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. To determine the therapeutic G-tube placement rate during chemoradiation.
SECONDARY OBJECTIVES:
I. 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.
V. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Supportive care (pea protein oral nutrition supplement)
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.
干预措施: Dietary Supplement (Dietary Supplement)
Supportive care (pea protein oral nutrition supplement)
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.
干预措施: Quality-of-Life Assessment (Other)
Supportive care (pea protein oral nutrition supplement)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Compliance rate
时间窗: Up to 1 month post chemoradiation
Will calculate the compliance rate and the corresponding 95% exact confidence interval.
Gastrostomy (G)-tube placement rate
时间窗: 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.
次要结局
- Weight change measurement(Up to 2 years)
- Overall survival(Up to 2 years)
- Incidence of adverse events (AEs)(Up to 2 years)
- Local/locoregional control(Up to 2 years)
- Body mass index change measurement (BMI)(Up to 2 years)
- Patient-reported quality of life (QOL): The Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN).(Up to 2 years)
- Global Leadership Initiative on Malnutrition criteria(Up to 2 years)
- Patient-reported quality of life (QOL): The University of Washington Quality of Life Questionnaire (UW-QOL).(Up to 2 years)
- Distant metastasis-free survival(Up to 2 years)