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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952210
• Other study ID #: 201205017RIC
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: April 22, 2014
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Behavioral:
• nutritional consultation and exercise program
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.
• usual care
pre-CCRT education included self-care during CCRT and body weight maintenance

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No