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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT02027948

Collaborator

(none)

Enrollment

Locations

Arm

98.2

Actual Duration (Months)

3.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Localized Stage I-III Esophageal Cancer Gastroesophageal Junction Cancer	Other: nutritional and functional assessments	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 23, 2013

Actual Primary Completion Date :

Mar 1, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)	Basking Ridge	New Jersey	United States
2	Memorial Sloan Kettering Monmouth (Consent Only)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Consent only)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Cancer Center at Commack (Consent Only)	Commack	New York	United States	11725
6	Memorial Sloan Kettering West Harrison (Consent Only)	Harrison	New York	United States	10604
7	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065