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

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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Key information

Conditions

Localized Stage I-III Esophageal Cancer Gastroesophageal Junction Cancer

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2022
Study completion: 2022
First posted: Jan 6, 2014
Registry last updated: Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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