Personalized Nutrition Counseling to Improve the Nutritional Status of Esophageal Cancer or Head and Neck Cancer Patients Undergoing Concurrent Chemoradiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- BMI in kg/m^2-W5
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pathologically and CT confirmed esophageal cancer or head and neck cancer
- •CCRT therapy
- •ECOG performance status grade≦2
- •agree to participate the trial
- •over 18 years
- •no pregnant
Exclusion Criteria
- •have two or more cancers
- •gastrointestinal tract cannot function
- •NYHA class 4
- •abnormal liver and kidney function
- •Abnormal bone marrow hematopoiesis
Outcomes
Primary Outcomes
BMI in kg/m^2-W5
Time Frame: 5th week
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W6
Time Frame: 6th week
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W30
Time Frame: 30th week
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W1
Time Frame: baseline
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W30
Time Frame: 30th week
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W1
Time Frame: baseline
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W2
Time Frame: 2nd week
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W3
Time Frame: 3rd week
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W4
Time Frame: 4th week
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W12
Time Frame: 12th week
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W18
Time Frame: 18th week
Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W2
Time Frame: 2nd week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W3
Time Frame: 3rd week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W4
Time Frame: 4th week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W5
Time Frame: 5th week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W6
Time Frame: 6th week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W12
Time Frame: 12th week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W18
Time Frame: 18th week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W30
Time Frame: 30th week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W1
Time Frame: baseline
Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W2
Time Frame: 2nd week
Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W3
Time Frame: 3rd week
Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W4
Time Frame: 4th week
Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W5
Time Frame: 5th week
Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W6
Time Frame: 6th week
Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W12
Time Frame: 12th week
Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W18
Time Frame: 18th week
Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W30
Time Frame: 30th week
Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W1
Time Frame: baseline
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W2
Time Frame: 2nd week
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W3
Time Frame: 3rd week
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W4
Time Frame: 4th week
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W5
Time Frame: 5th week
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W6
Time Frame: 6th week
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W12
Time Frame: 12th week
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W18
Time Frame: 18th week
Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
CTC cell number counting in number-W1
Time Frame: baseline
Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status
CTC cell number counting in number-W6
Time Frame: 6th week
Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status
CTC cell number counting in number-W18
Time Frame: 18th week
Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status
Secondary Outcomes
- Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W1(baseline)
- Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W3(3th week)
- Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W6(6th week)
- aPG SGA Questionnaire W18(18th week)
- SGA-Questionnaire W30(30th week)
Investigators
Hsuan-Chih Kuo
Professor Attending Physicians
Chang Gung Memorial Hospital