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The purpose of the study is to improve the nutritional status of esophageal cancer patients undergoing concurrent chemoradiotherapy by the personalized nutrition counseling.Dietitians consult with participants which invited to be the experimental group and follow up weekly through communication software (Line) or telephone remote methods. Dietitians provide the dietary advice base on the guidance of the cancer diet principles, and give on assessment and diet adjustments. At the same time, Under the same condition of nutritional supplements in both the experimental group and the control group, the investigators explore the changes in the quality of life and nutritional status of the subjects by evaluating with the nutrition Index (PG-SGA) and quality of life (EORTC QLQ-C30 questionnaire Taiwan version) questionnaire evaluation and recode the basic physical data, including body weight, grip strength, body muscle fat composition. Therefore, investigators conducted this study to appoint dietitian to arrange personalized nutrition consultation for esophageal cancer patients to improve the nutritional status of these patients.
Approximately 60-85% of esophageal cancer patients present with malnutrition at diagnosis (1). Malnutrition, defined as body weight loss of more than 10% over the previous 6 months is associated with treatment response and survival (2). Around 38% of esophageal cancer patients are managed with curative intent in the form of neoadjuvant chemotherapy or chemoradiotherapy followed by esophagectomy (3). Individuals are at increased risk of malnutrition arising from disease related symptoms and neoadjuvant treatment. Nutritional status serves as an important risk factor for major complications after operation (4) Therefore, assessment of nutritional status should be undertaken for all esophageal cancer patients, especially for those who are planned to receive esophagectomy (5). The nutritional assessment includes hand grip for muscle mass (6), body composition for lean body mass and sarcopenia (7), body mass index- body weight loss grade (BMI-BWL grade) for generalized nutrition status (8). These tools are needed to be integrated and individualized to esophageal cancer patients to improve outcome. Therefore, investigators conducted this trial to appoint dietitian to arrange personalized nutrition consultation for esophageal cancer patients to improve the nutritional status of these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Under the same condition of nutritional supplements in both the experimental group and the control group,the investigators explore the changes in the quality of life and nutritional status of the subjects by evaluating with the nutrition Index (PG-SGA) and quality of life (EORTC QLQ-C30 questionnaire Taiwan version) questionnaire evaluation and recode the basic physical data, including body weight, grip strength, body muscle fat composition. | ||
| experimental | Dietitians consult with participants which invited to be the experimental group and follow up weekly through communication software (Line) or telephone remote methods. Dietitians provide the dietary advice base on the guidance of the cancer diet principles, and give on assessment and diet adjustments.Under the same condition of nutritional supplements in both the experimental group and the control group,the investigators explore the changes in the quality of life and nutritional status of the subjects by evaluating with the nutrition Index (PG-SGA) and quality of life (EORTC QLQ-C30 questionnaire Taiwan version) questionnaire evaluation and recode the basic physical data, including body weight, grip strength, body muscle fat composition. |
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| Measure | Description | Time Frame |
|---|---|---|
| BMI in kg/m^2-W1 | Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status | baseline |
| BMI in kg/m^2-W2 | Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status | 2nd week |
| BMI in kg/m^2-W3 | Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status | 3rd week |
| BMI in kg/m^2-W4 | Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status | 4th week |
| BMI in kg/m^2-W5 | Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status | 5th week |
| BMI in kg/m^2-W6 | Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status | 6th week |
| BMI in kg/m^2-W12 | Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status | 12th week |
| BMI in kg/m^2-W18 |
| Measure | Description | Time Frame |
|---|---|---|
| Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W1 | nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants. | baseline |
| Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W3 |
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Inclusion Criteria:
Exclusion Criteria:
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Esophageal cancer or head and neck cancer patients undergoing concurrent chemoradiotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chia-Hsun Hsieh | Contact | 0975366137 | wisdom5000@gmail.com | |
| Hsuan-Chih Kuo | Contact | 0975360665 | hsuanchihkuo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hsuan-Chih Kuo | Division of Oncology, Chang Gung Memorial Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | New Taipei City | 236 | 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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Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status |
| 18th week |
| BMI in kg/m^2-W30 | Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status | 30th week |
| hand grip in kg-W1 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | baseline |
| hand grip in kg-W2 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 2nd week |
| hand grip in kg-W3 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 3rd week |
| hand grip in kg-W4 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 4th week |
| hand grip in kg-W5 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 5th week |
| hand grip in kg-W6 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 6th week |
| hand grip in kg-W12 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 12th week |
| hand grip in kg-W18 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 18th week |
| hand grip in kg-W30 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 30th week |
| body fat in kg-W1 | Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status | baseline |
| body fat in kg-W2 | Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status | 2nd week |
| body fat in kg-W3 | Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status | 3rd week |
| body fat in kg-W4 | Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status | 4th week |
| body fat in kg-W5 | Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status | 5th week |
| body fat in kg-W6 | Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status | 6th week |
| body fat in kg-W12 | Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status | 12th week |
| body fat in kg-W18 | Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status | 18th week |
| body fat in kg-W30 | Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status | 30th week |
| muscle weight in kg-W1 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | baseline |
| muscle weight in kg-W2 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | 2nd week |
| muscle weight in kg-W3 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | 3rd week |
| muscle weight in kg-W4 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | 4th week |
| muscle weight in kg-W5 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | 5th week |
| muscle weight in kg-W6 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | 6th week |
| muscle weight in kg-W12 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | 12th week |
| muscle weight in kg-W18 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | 18th week |
| muscle weight in kg-W30 | Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status | 30th week |
| CTC cell number counting in number-W1 | Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status | baseline |
| CTC cell number counting in number-W6 | Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status | 6th week |
| CTC cell number counting in number-W18 | Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status | 18th week |
nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants. |
| 3th week |
| Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W6 | nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants. | 6th week |
| aPG SGA Questionnaire W18 | nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants. | 18th week |
| SGA-Questionnaire W30 | nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants. | 30th week |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |