Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06829095

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Personalized Nutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. BMI in kg/m^2-W1

    Time frame: baseline

    Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. hand grip in kg-W1

    Time frame: baseline

    Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. body fat in kg-W1

    Time frame: baseline

    Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. muscle weight in kg-W1

    Time frame: baseline

    Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  1. Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W1

    Time frame: baseline

    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.

  2. Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W3

    Time frame: 3th 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.

  3. Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W6

    Time frame: 6th 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.

  4. aPG SGA Questionnaire W18

    Time frame: 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.

  5. SGA-Questionnaire W30

    Time frame: 30th 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Hsun Hsieh

CONTACT

[email protected]

0975366137

Hsuan-Chih Kuo

CONTACT

[email protected]

0975360665

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.