Clinical trial NCT02027948: A Nutritional Management Algorithm in Older Patients With Locally Advanced Esophageal Cancer
Official title: A Nutritional Management Algorithm in Older Patients With Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Localized Stage I-III Esophageal Cancer
Gastroesophageal Junction Cancer
Keywords: nutritional management algorithm
nutritional and functional assessments
13-264
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: feasibility of a nutritional management algorithm
timeFrame: 2 years
Secondary outcomes:
measure: treatment toxicity of chemoradiotherapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center at Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison (Consent Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Won, MD
role: PRINCIPAL_INVESTIGATOR
References: