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Clinical Trials/NCT01952210
NCT01952210
Completed
Not Applicable

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

National Taiwan University Hospital1 site in 1 country56 target enrollmentStarted: June 2012Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
1
Primary Endpoint
General nutritional status

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

General nutritional status

Time Frame: 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 Outcomes

  • Treatment tolerance(10 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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