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

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Behavioral: nutritional consultation and exercise program; Behavioral: usual care

• Registration Number: NCT01952210
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-22
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutrition consultation and exercise program	nutritional consultation and exercise program	individual nutritional consultation and exercise
usual care	usual care	pre-CCRT education included self-care during CCRT and body weight maintenance

Primary Outcome Measures

Name	Time	Method
General nutritional status	10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Treatment tolerance	10 weeks	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan