A Phase II Study Integrating Soylent™ Meal Replacement to Reduce Gastrostomy Tube Rates in Patients With Head &Amp; Neck Cancer Undergoing Chemoradiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Compliance with Soylent nutritional supplementation
研究概览
简要总结
This phase II trial studies Soylent in reducing gastrostomy tube rates in patients with head and neck cancer that has spread to nearby tissues or lymph nodes (locally advanced) who are undergoing chemoradiotherapy. Soylent is a liquid meal replacement product that may reduce the risk of malnutrition and gastrostomy placement during or following treatment for head and neck cancer with chemoradiation.
详细描述
PRIMARY OBJECTIVES:
I. To determine the compliance rate of oral nutritional replacement with Soylent.
II. To determine the overall therapeutic gastrostomy (G)-tube placement rate (G-tube placement from the 1st day of chemoradiation up to 4 weeks following treatment).
SECONDARY OBJECTIVES:
I. To determine weight loss and body mass index (BMI) changes during and following treatment.
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
- •No history of prior radiotherapy to the head and neck; however, if previous treatment was superficial skin radiotherapy without regional lymph node treatment this will be allowed
- •Karnofsky performance status (KPS) >= 70
- •Body mass index >= 18 kg/m^2
- •No evidence of metastatic disease (M1 disease)
- •No G-tube placement prior to initiation of chemoradiation
- •Eligible to undergo concurrent chemotherapy as determined by treating medical oncologist
- •If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to proceeding with chemoradiation; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for at least 4 weeks after study treatment
- •Ability to understand and willingness to sign a written informed consent
- •Able to tolerate the taste of one of the flavors of the oral nutritional supplement Soylent
- •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 have previously received therapeutic radiation therapy to the head and neck except for superficial skin radiotherapy is allowed
- •Patients who had G-tube placement due to concern for aspiration or due to severe malnutrition in advance of chemoradiation
- •Patients underweight in advance of chemoradiation (BMI < 18 kg/m^2)
- •Patients who refuse to use Soylent oral nutritional supplementation due to its taste or other patient preference reasons
- •Patients with allergies to any of the ingredients contained in the nutritional supplement
- •Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
- •Refusal to sign the informed consent
- •Refusal to participate in the Swallow Preservation Program prior to start of Soylent if applicable
- •Evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation
- •Distant metastatic disease (M1 disease)
研究组 & 干预措施
Supportive care (Soylent)
Patients receive Soylent PO for up to 3 months.
干预措施: Questionnaire Administration (Other)
Supportive care (Soylent)
Patients receive Soylent PO for up to 3 months.
干预措施: Soylent Graham Dietary Supplement (Dietary Supplement)
Supportive care (Soylent)
Patients receive Soylent PO for up to 3 months.
干预措施: Laboratory Biomarker Analysis (Other)
Supportive care (Soylent)
Patients receive Soylent PO for up to 3 months.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Compliance with Soylent nutritional supplementation
时间窗: Up to 24 months
The compliance rate and the corresponding 95% exact confidence interval will be calculated.
Therapeutic gastrostomy (G)-tube placement rate
时间窗: Up to 24 months
The G-tube placement rate will be analyzed using one-sample exact binomial test. The 95% exact confidence interval will be provided.
次要结局
- C-reactive protein(Up to 24 months)
- Interleukin-6(Up to 24 months)
- Weight change(Up to 24 months)
- Body mass index(Up to 24 months)
- Treatment breaks(Up to 24 months)
- Timing and duration of G-tube placement(Up to 24 months)
- Serum human papilloma virus deoxyribonucleic acid(Up to 24 months)
- Pre-albumin(Up to 24 months)
- Albumin(Up to 24 months)
- Tumor necrosis factor(Up to 24 months)
- Vitamin A(Up to 24 months)
- Vitamin C(Up to 24 months)
- Vitamin D(Up to 24 months)
- Tryptophan(Up to 24 months)
- Kynurenine(Up to 24 months)
- Leptin(Up to 24 months)
- Adiponectin(Up to 24 months)
- Complete metabolic panel(Up to 24 months)
- Complete blood count(Up to 24 months)
- Radiosensitivity biomarker panel(Up to 24 months)
- Incidence of physician-reported acute and late toxicities(Up to 24 months)
- University of Washington and Functional Assessment of Cancer Therapy questionnaire assessment of Patient-reported quality of life(Up to 24 months)
- Local/loco-regional control(Up to 24 months)
- Distant metastasis-free survival(Up to 24 months)
- Overall survival(Up to 24 months)