Menu
Recruiting NCT06829095

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

— Observational Esophageal Cancer Personalized Nutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Esophageal Cancer, Personalized Nutrition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • BMI in kg/m^2-W1 [Time frame: baseline]
  • BMI in kg/m^2-W2 [Time frame: 2nd week]
  • BMI in kg/m^2-W3 [Time frame: 3rd week]
  • BMI in kg/m^2-W4 [Time frame: 4th week]
  • BMI in kg/m^2-W5 [Time frame: 5th week]
  • BMI in kg/m^2-W6 [Time frame: 6th week]
  • BMI in kg/m^2-W12 [Time frame: 12th week]
  • BMI in kg/m^2-W18 [Time frame: 18th week]
  • BMI in kg/m^2-W30 [Time frame: 30th week]
  • hand grip in kg-W1 [Time frame: baseline]
Secondary outcome measures (5)
  • Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W1 [Time frame: baseline]
  • Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W3 [Time frame: 3th week]
  • Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W6 [Time frame: 6th week]
  • aPG SGA Questionnaire W18 [Time frame: 18th week]
  • SGA-Questionnaire W30 [Time frame: 30th week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital — New Taipei City

Identifiers

NCT: NCT06829095 · 202300755B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗