Clinical trial NCT06829095: Personalized Nutrition Counseling and Nutritional Status of Esophageal Cancer and HNSCC Patients Undergoing CCRT
Official title: Personalized Nutrition Counseling to Improve the Nutritional Status of Esophageal Cancer or Head and Neck Cancer Patients Undergoing Concurrent Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Personalized Nutrition
Keywords: Personalized nutrition
Esophageal cancer
Concurrent chemoradiotherapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Esophageal cancer or head and neck cancer patients undergoing 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.

Eligibility criteria: 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

Primary outcomes:
measure: BMI in kg/m^2-W1
timeFrame: baseline
measure: BMI in kg/m^2-W2
timeFrame: 2nd week
measure: BMI in kg/m^2-W3
timeFrame: 3rd week
measure: BMI in kg/m^2-W4
timeFrame: 4th week
measure: BMI in kg/m^2-W5
timeFrame: 5th week
measure: BMI in kg/m^2-W6
timeFrame: 6th week
measure: BMI in kg/m^2-W12
timeFrame: 12th week
measure: BMI in kg/m^2-W18
timeFrame: 18th week
measure: BMI in kg/m^2-W30
timeFrame: 30th week
measure: hand grip in kg-W1
timeFrame: baseline
measure: hand grip in kg-W2
timeFrame: 2nd week
measure: hand grip in kg-W3
timeFrame: 3rd week
measure: hand grip in kg-W4
timeFrame: 4th week
measure: hand grip in kg-W5
timeFrame: 5th week
measure: hand grip in kg-W6
timeFrame: 6th week
measure: hand grip in kg-W12
timeFrame: 12th week
measure: hand grip in kg-W18
timeFrame: 18th week
measure: hand grip in kg-W30
timeFrame: 30th week
measure: body fat in kg-W1
timeFrame: baseline
measure: body fat in kg-W2
timeFrame: 2nd week
measure: body fat in kg-W3
timeFrame: 3rd week
measure: body fat in kg-W4
timeFrame: 4th week
measure: body fat in kg-W5
timeFrame: 5th week
measure: body fat in kg-W6
timeFrame: 6th week
measure: body fat in kg-W12
timeFrame: 12th week
measure: body fat in kg-W18
timeFrame: 18th week
measure: body fat in kg-W30
timeFrame: 30th week
measure: muscle weight in kg-W1
timeFrame: baseline
measure: muscle weight in kg-W2
timeFrame: 2nd week
measure: muscle weight in kg-W3
timeFrame: 3rd week
measure: muscle weight in kg-W4
timeFrame: 4th week
measure: muscle weight in kg-W5
timeFrame: 5th week
measure: muscle weight in kg-W6
timeFrame: 6th week
measure: muscle weight in kg-W12
timeFrame: 12th week
measure: muscle weight in kg-W18
timeFrame: 18th week
measure: muscle weight in kg-W30
timeFrame: 30th week
measure: CTC cell number counting in number-W1
timeFrame: baseline
measure: CTC cell number counting in number-W6
timeFrame: 6th week
measure: CTC cell number counting in number-W18
timeFrame: 18th week
Secondary outcomes:
measure: Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W1
timeFrame: baseline
measure: Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W3
timeFrame: 3th week
measure: Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W6
timeFrame: 6th week
measure: aPG SGA Questionnaire W18
timeFrame: 18th week
measure: SGA-Questionnaire W30
timeFrame: 30th week
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Division of Oncology, Chang Gung Memorial Hospital
name: Hsuan-Chih Kuo
role: STUDY_DIRECTOR
References: