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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-23

Study Completion Date

2022-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Localized Stage I-III Esophageal Cancer Gastroesophageal Junction Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

nutritional and functional assessments

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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