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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Personalized Nutrition

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 Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Chia-Hsun Hsieh; Phone Number: 0975366137; Email: wisdom5000@gmail.com
• Study Contact Backup: Name: Hsuan-Chih Kuo; Phone Number: 0975360665; Email: hsuanchihkuo@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 236
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Hsuan-Chih Kuo; Phone Number: 0975366137; Email: wisdom2000@gmail.com
    • Contact: Chia-Hsun Hsieh; Phone Number: 0975360665; Email: hsuanchihkuo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Esophageal cancer or head and neck cancer patients undergoing concurrent chemoradiotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Hsuan-Chih Kuo, Division of Oncology, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Esophageal cancer; Concurrent chemoradiotherapy; Personalized nutrition
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 202300755B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No