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Esophageal CancerNCT06829095

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

An observational study of Esophageal Cancer and Personalized Nutrition, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Personalized Nutrition
How many people
90 participants
Where
1 siteTaiwan
Study dates
22 Aug 2023to 30 Jun 2025
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Esophageal cancer or head and neck cancer patients undergoing concurrent chemoradiotherapy

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chia-Hsun Hsieh contact

0975366137

wisdom5000@gmail.com

Hsuan-Chih Kuo contact

0975360665

hsuanchihkuo@gmail.com

Taiwan1 site, 1 recruiting
  • Chang Gung Memorial Hospital

    New Taipei City, 236

    Hsuan-Chih Kuo, 0975366137, wisdom2000@gmail.com

    Chia-Hsun Hsieh, 0975360665, hsuanchihkuo@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Keywords
Personalized nutrition, Esophageal cancer, Concurrent chemoradiotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06829095
Study groupRoleWhat they receive
controlUnder 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.
experimentalDietitians 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI in kg/m^2-W1

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

    Measured: baseline

  2. BMI in kg/m^2-W2

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

    Measured: 2nd week

  3. BMI in kg/m^2-W3

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

    Measured: 3rd week

  4. BMI in kg/m^2-W4

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

    Measured: 4th week

  5. BMI in kg/m^2-W5

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

    Measured: 5th week

  6. BMI in kg/m^2-W6

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

    Measured: 6th week

  7. BMI in kg/m^2-W12

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

    Measured: 12th week

  8. BMI in kg/m^2-W18

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

    Measured: 18th week

  9. BMI in kg/m^2-W30

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

    Measured: 30th week

  10. hand grip in kg-W1

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

    Measured: baseline

  11. hand grip in kg-W2

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

    Measured: 2nd week

  12. hand grip in kg-W3

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

    Measured: 3rd week

  13. hand grip in kg-W4

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

    Measured: 4th week

  14. hand grip in kg-W5

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

    Measured: 5th week

  15. hand grip in kg-W6

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

    Measured: 6th week

  16. hand grip in kg-W12

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

    Measured: 12th week

  17. hand grip in kg-W18

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

    Measured: 18th week

  18. hand grip in kg-W30

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

    Measured: 30th week

  19. body fat in kg-W1

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

    Measured: baseline

  20. body fat in kg-W2

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

    Measured: 2nd week

  21. body fat in kg-W3

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

    Measured: 3rd week

  22. body fat in kg-W4

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

    Measured: 4th week

  23. body fat in kg-W5

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

    Measured: 5th week

  24. body fat in kg-W6

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

    Measured: 6th week

  25. body fat in kg-W12

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

    Measured: 12th week

  26. body fat in kg-W18

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

    Measured: 18th week

  27. body fat in kg-W30

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

    Measured: 30th week

  28. muscle weight in kg-W1

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

    Measured: baseline

  29. muscle weight in kg-W2

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

    Measured: 2nd week

  30. muscle weight in kg-W3

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

    Measured: 3rd week

  31. muscle weight in kg-W4

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

    Measured: 4th week

  32. muscle weight in kg-W5

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

    Measured: 5th week

  33. muscle weight in kg-W6

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

    Measured: 6th week

  34. muscle weight in kg-W12

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

    Measured: 12th week

  35. muscle weight in kg-W18

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

    Measured: 18th week

  36. muscle weight in kg-W30

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

    Measured: 30th week

  37. 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

    Measured: baseline

  38. 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

    Measured: 6th week

  39. 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

    Measured: 18th week

Secondary outcomes (5)
  1. 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.

    Measured: baseline

  2. 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.

    Measured: 3th week

  3. 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.

    Measured: 6th week

  4. 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.

    Measured: 18th week

  5. 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.

    Measured: 30th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start22 Aug 2023
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
90 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06829095
Sponsor's protocol ID
202300755B0
Status last verified
Feb 2025
First submitted
10 Nov 2023
Last updated
17 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Cancer and Personalized Nutrition, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chia-Hsun Hsieh (0975366137, wisdom5000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI in kg/m^2-W1 (time frame: baseline). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.

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