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

Gastroesophageal Junction Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027948
• Other study ID #: 13-264
• Status: Completed
• Phase: N/A
• Start date: December 23, 2013
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Gastroesophageal Junction Cancer
• Localized Stage I-III Esophageal Cancer

Intervention

Other:
• nutritional and functional assessments
Patients will undergo nutritional & functional assessments along the continuum of their chemoradiotherapy treatment. The initial assessment will be measurements of height, weight, & baseline weight loss. Patients will receive chemotherapy & radiation as per standard practice at MSKCC, which is induction chemotherapy for approximately 3 weeks, followed by concurrent chemoradiotherapy. A commonly used regimen is weekly carboplatin (AUC 2) with paclitaxel (50 mg/m2) & radiation consisting of 5040 cGy over 28 fractions. Patients in this study will undergo assessments at three time points (at baseline, after induction chemotherapy, & post-treatment.) At baseline, all patients will complete the functional assessment, dysphagia scale, & Mini- Nutritional Assessment (MNA). According to the baseline MNA score, patients will be categorized as "normal nutrition," "at risk for malnutrition," or "malnourished" & receive the appropriate intervention.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)	Basking Ridge	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 Monmouth (Consent Only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of a nutritional management algorithm	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)	2 years
Secondary	treatment toxicity of chemoradiotherapy	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center