- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027948
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (Consent only)
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Consent only)
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center at Commack (Consent Only)
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering West Harrison (consent only)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth Won, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-264
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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