Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient

Study Overview
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Brief Summary
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In this randomized pilot study, a nutritional consultation combining exercise program is planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation. The purpose of this study is to determine the effects of nutritional and exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation.

Detailed Description
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Patients with esophageal cancer are often malnourished at presentation due to the primary symptom of dysphagia. Treatments for esophageal cancer are commonly multimodal, incorporating polychemotherapy, radiotherapy and surgery. These treatments frequently cause or exacerbate poor nutritional status. Recent literature has proved that malnutrition is associated with longer hospital stays, reduced responses to and increased complications from therapies, increased costs, worse quality of life and lower survival rate. The aim of this study was to investigate the effectiveness of an intensive nutritional consultation and exercise program on nutritional status and outcomes in patients undergoing chemoradiation for esophageal cancer.

Official Title
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The Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient Receiving Neoadjuvant Chemoradiation.

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Behavioral: nutritional consultation and exercise program
* Behavioral: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of locally advanced esophageal cancer, neoadjuvant chemoradiation is indicated Informed consent signed Exclusion Criteria: stage IV, underwent palliative chemotherapy or radiotherapy patient clinically significant cardiac or pulmonary disease Unable to walk or exercise

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutrition consultation and exercise program<br>individual nutritional consultation and exercise | Behavioral: nutritional consultation and exercise program<br>* The protocol involved 20-30 minutes of individual-based nutrition consultation every week during the 8-week chemoradiation therapy. The exercise program consisted of upper extremity muscle training and walking exercise at 45%-65% of maximal heart rate reserve, 3 times per week, 20-30 minutes per session.<br>* Other names: nutritional consultation;|
| Active Comparator: usual care<br>pre-CCRT education included self-care during CCRT and body weight maintenance | Behavioral: usual care<br>* pre-CCRT education included self-care during CCRT and body weight maintenance<br>* Other names: pre-CCRT education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General nutritional status | Measure tools included patient-generated-subjective global assessment score, hand-grip strength, body weight, body composition analysis, and 6-mim walk test were used to define the general nutritional status of esophageal cancer patient. The study measures were chosen on the basis that they had been utilized in previous cancer trials examining the effects of various interventions on weight loss, endurance and strength, and simple enough to be administered in the clinical setting. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment tolerance | To evaluate the treatment tolerance, the following data were assessed: number of treatment breaks or delay for toxicity, grading of acute chemoradiation-related toxicity, number of unplanned hospitalization for adverse effects. | 10 weeks |