A Nutritional Management Algorithm in Older Patients With Locally Advanced Esophageal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 7
- Primary Endpoint
- feasibility of a nutritional management algorithm
Study Overview
Brief Summary
Patients with esophageal and gastroesophageal junction (GEJ) cancer often have weight loss, swallowing problems, and poor appetite. This may affect their ability to tolerate cancer treatment.
The purpose of this study is to see if the researchers can apply a set of nutrition guidelines designed specifically for patients with cancer who are older than 65 years of age. The questions will allow them to assess the nutritional status and make appropriate referrals. If the patients are having swallowing problems or losing weight, the researchers want to address the nutritional problems early in the course of their treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must be ≥ age of 65; no maximum age limit.
- •Patients who will receive induction chemotherapy followed by combined chemoradiotherapy at MSKCC for localized stage I-III esophageal or gastroesophageal junction cancer.
- •Patients can receive chemoradiotherapy preoperatively prior to surgical resection or as definitive/primary chemoradiotherapy.
- •Patients can be KPS ≥60, as long as primary provider feels that patient is candidate for combined modality chemoradiotherapy
- •Be able to provide informed consent
Exclusion Criteria
- •Enrolled on a phase I trial
- •Patients with a feeding tube previously placed.
- •Not English-speaking
Arms & Interventions
nutritional management
The proposed study will be a prospective feasibility study of a nutritional management algorithm with risk-based guidelines in older adults (n=50) with newly diagnosed locally advanced esophageal cancer receiving preoperative or definitive chemoradiotherapy with an induction chemotherapy approach. Eligible patients must be age ≥ 65 years old. While all patients with esophageal cancer may benefit from this intervention, we wish to target the most vulnerable population (older patients who are at highest risk of malnutrition) in this pilot study.
Intervention: nutritional and functional assessments (Other)
Outcomes
Primary Outcomes
feasibility of a nutritional management algorithm
Time Frame: 2 years
Various validated assessments of nutritional status have been described. Nutritional status can be evaluated using: 1) anthropometric measures (i.e. weight loss, body mass index (BMI), triceps skin fold thickness, arm circumference), 2) immunological measurements (i.e. absolute lymphocyte count), and 3) serum protein markers (i.e. albumin, prealbumin, transferrin, and retinol-binding protein)
Secondary Outcomes
- treatment toxicity of chemoradiotherapy(2 years)