Improvement of nutritional status in patients with head and neck cancer undergoing radiotherapy Cancer
Conditions
Interventions
Subjects were recruited before radiotherapy, and those meeting the inclusion criteria were randomly divided into two groups (intervention group and control group) according to computer-generated rando
Sponsors
First People's Hospital of Kunshan
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Meeting the diagnostic criteria for head and neck cancer specified in the NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancers (Version 1.2023) 3. Undergoing head and neck radiotherapy for the first time 4. Having a nutritional risk, as indicated by a score of = 3 on the Nutritional Risk Screening 2002 (NRS-2002) 5. Expected survival period > 6 months 6. Providing informed consent and voluntarily participating in the study 7. Having normal cognitive and communication abilities
Exclusion criteria
Exclusion criteria: 1. Patients with other severe physical diseases such as concurrent malignant tumors, including multiple distant metastases, multiple organ failure, and loss of independent activity ability 2. Patients for whom the disease condition needs to be concealed at the request of their family members Exclusion criteria (for withdrawal): 1. Termination of radiotherapy due to severe radiotherapy-related complications 2. Transfer to another hospital for treatment due to personal reasons 3. Voluntary withdrawal from the study or inability to complete the study for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-Generated Subjective Global Assessment (PG-SGA) . This scale consists of two parts: patient self-assessment and medical staff assessment at baseline(day1ofradiotherapy)and intervention completion (the first radiotherapy clinic follow up visit 3 months after the end of one radiotherapy cycle). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma protein concentration is measured using blood biochemical analysis at baseline (day 1 of radiotherapy) and at intervention completion (first radiotherapy clinic follow-up visit, 3 months after the end of one radiotherapy cycle) 2. Serum albumin level is measured using enzyme-linked immunosorbent assay (ELISA) at baseline and intervention completion 3. Serum prealbumin level is measured using enzyme-linked immunosorbent assay (ELISA) at baseline and intervention completion 4. Body height is measured using a stadiometer at baseline and intervention completion 5. Body weight is measured using a calibrated digital scale at baseline and intervention completion 6. Body mass index (BMI) is calculated as weight (kg) divided by the square of height (m²) at baseline and intervention completion 7. Hand-grip strength is measured using the CAMRY EH101 electronic hand dynamometer at baseline and intervention completion | — |
Countries
China
Contacts
Public ContactJuan Song
Outcome results
None listed