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

NCT02027948 | Completed

• 1 other identifier: 13-264
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

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.

Conditions

Localized Stage I-III Esophageal Cancer; Gastroesophageal Junction Cancer

Keywords

nutritional management algorithm; nutritional and functional assessments; 13-264

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• treatment toxicity of chemoradiotherapy

  2 years

Study Arms (1)

nutritional management

EXPERIMENTAL

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.

Other: nutritional and functional assessments

Interventions

nutritional and functional assessments OTHER

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.

nutritional management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Enrolled on a phase I trial
• Patients with a feeding tube previously placed.
• Not English-speaking

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center at Commack (Consent Only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering West Harrison (Consent Only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Elizabeth Won, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 6, 2014
• Study Start: December 23, 2013
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

US (7)