Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient
The Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient Receiving Neoadjuvant Chemoradiation.
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 24, 2013
CompletedFirst Posted
Study publicly available on registry
September 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 23, 2014
April 1, 2014
1.5 years
September 24, 2013
April 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Treatment tolerance
10 weeks
Study Arms (2)
nutrition consultation and exercise program
EXPERIMENTALindividual nutritional consultation and exercise
usual care
ACTIVE COMPARATORpre-CCRT education included self-care during CCRT and body weight maintenance
Interventions
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.
pre-CCRT education included self-care during CCRT and body weight maintenance
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of locally advanced esophageal cancer, neoadjuvant chemoradiation is indicated
- Informed consent signed
You may not qualify if:
- stage IV, underwent palliative chemotherapy or radiotherapy patient
- clinically significant cardiac or pulmonary disease
- Unable to walk or exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl Chia-Hui Chen
Department of Nursing, National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2013
First Posted
September 27, 2013
Study Start
June 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 23, 2014
Record last verified: 2014-04