Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
nutritional consultation and exercise program
usual care
Sponsored by
About this trial
This is an interventional prevention trial for Esophageal Cancer
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nutrition consultation and exercise program
usual care
Arm Description
individual nutritional consultation and exercise
pre-CCRT education included self-care during CCRT and body weight maintenance
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01952210
First Posted
September 24, 2013
Last Updated
April 22, 2014
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01952210
Brief Title
Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient
Official Title
The Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient Receiving Neoadjuvant Chemoradiation.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nutrition consultation and exercise program
Arm Type
Experimental
Arm Description
individual nutritional consultation and exercise
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
pre-CCRT education included self-care during CCRT and body weight maintenance
Intervention Type
Behavioral
Intervention Name(s)
nutritional consultation and exercise program
Other Intervention Name(s)
nutritional consultation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Other Intervention Name(s)
pre-CCRT education
Intervention Description
pre-CCRT education included self-care during CCRT and body weight maintenance
Primary Outcome Measure Information:
Title
General nutritional status
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Treatment tolerance
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Chia-Hui Chen
Organizational Affiliation
Department of Nursing, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient
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