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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutrition consultation and exercise program | Experimental | individual nutritional consultation and exercise |
|
| usual care | Active Comparator | pre-CCRT education included self-care during CCRT and body weight maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional consultation and exercise program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Chia-Hui Chen | Department of Nursing, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
|
| usual care | Behavioral | pre-CCRT education included self-care during CCRT and body weight maintenance |
|
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |