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Personalized Nutrition Counseling and Nutritional Status of Esophageal Cancer and HNSCC Patients Undergoing CCRT

Personalized Nutrition Counseling to Improve the Nutritional Status of Esophageal Cancer or Head and Neck Cancer Patients Undergoing Concurrent Chemoradiotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06829095
Enrollment
90
Registered
2025-02-17
Start date
2023-08-22
Completion date
2025-06-30
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Personalized Nutrition

Keywords

Personalized nutrition, Esophageal cancer, Concurrent chemoradiotherapy

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. pathologically and CT confirmed esophageal cancer or head and neck cancer 2. CCRT therapy 3. ECOG performance status grade≦2 4. agree to participate the trial 5. over 18 years 6. no pregnant

Exclusion criteria

1. have two or more cancers 2. gastrointestinal tract cannot function 3. NYHA class 4 4. abnormal liver and kidney function 5. Abnormal bone marrow hematopoiesis

Design outcomes

Primary

MeasureTime frameDescription
CTC cell number counting in number-W1818th weekDocument of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W1212th weekDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W1818th weekDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W3030th weekDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
CTC cell number counting in number-W1baselineDocument of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status
CTC cell number counting in number-W66th weekDocument of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W22nd weekDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W1818th weekDocument of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W3030th weekDocument of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W1baselineDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W1baselineDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W22nd weekDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W33rd weekDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W44th weekDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W55th weekDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W66th weekDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W1212th weekDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W1818th weekDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
BMI in kg/m^2-W3030th weekDocument of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W1baselineDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W22nd weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W33rd weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W44th weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W55th weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W66th weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W1212th weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W1818th weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
hand grip in kg-W3030th weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W1baselineDocument of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W22nd weekDocument of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W33rd weekDocument of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W44th weekDocument of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W55th weekDocument of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W66th weekDocument of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
body fat in kg-W1212th weekDocument of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W33rd weekDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W44th weekDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W55th weekDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status
muscle weight in kg-W66th weekDocument of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status

Secondary

MeasureTime frameDescription
Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W33th weeknutrition 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.
Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W66th weeknutrition 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.
aPG SGA Questionnaire W1818th weeknutrition 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.
SGA-Questionnaire W3030th weeknutrition 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.
Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W1baselinenutrition 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.

Countries

Taiwan

Contacts

Primary ContactChia-Hsun Hsieh
wisdom5000@gmail.com0975366137
Backup ContactHsuan-Chih Kuo
hsuanchihkuo@gmail.com0975360665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026