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

NCT06829095 | Recruiting

• 1 other identifier: 202300755B0
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Personalized Nutrition

Keywords

Personalized nutrition; Esophageal cancer; Concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (39)

• 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 Outcomes (5)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Esophageal cancer or head and neck cancer patients undergoing concurrent chemoradiotherapy

You may qualify if:

• 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

You may not qualify if:

• have two or more cancers
• gastrointestinal tract cannot function
• NYHA class 4
• abnormal liver and kidney function
• Abnormal bone marrow hematopoiesis

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

New Taipei City, 236, Taiwan

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hsuan-Chih Kuo

  Division of Oncology, Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Chia-Hsun Hsieh

CONTACT

0975366137; wisdom5000@gmail.com

Hsuan-Chih Kuo

CONTACT

0975360665; hsuanchihkuo@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Attending Physicians

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: February 17, 2025
• Study Start: August 22, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

TW (1)