A Nutritional Management Algorithm in Older Patients With Locally Advanced Esophageal Cancer

Not Applicable

Completed

• Conditions: Localized Stage I-III Esophageal Cancer; Gastroesophageal Junction Cancer

• Registration Number: NCT02027948
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-23
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-06
• Status Verified: 2022-03
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
feasibility of a nutritional management algorithm	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 Outcome Measures

Name	Time	Method
treatment toxicity of chemoradiotherapy	2 years	Treatment toxicity of chemoradiotherapy will be summarized using descriptive statistics. Binomial proportions along with exact 95% confidence intervals will be estimated for proportions. Toxicity during the induction chemotherapy phase will be correlated with the baseline nutritional status (as determined by the MNA assessment) and baseline functional status using Fisher's exact test for categorical measures and Wilcoxon's rank sum test for numeric measures. Similarly, toxicity during chemoradiotherapy will be correlated with baseline MNA and functional status as well as with the malnutrition assessment using Fisher's exact test for categorical measures and Wilcoxon rank sum test for numeric measures.

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center at Commack (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering West Harrison (Consent Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States