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NCT Number: NCT07085988

Effect of Nutritional Management on Patients With Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is a malignant tumor that develops in the nasopharyngeal mucosal epithelium. Due to the disease itself and the impact of anti-tumor therapy, malnutrition has become a common clinical complication in patients with NPC, among which NPC patients receiving concurrent chemoradiotherapy are one of the groups with the highest incidence of malnutrition, and malnutrition seriously affects the prognosis of NPC patients. Nutritional management throughout the course has a positive impact on the prognosis and life management of NPC patients. As an immune-enhancing oral nutritional preparation, it is helpful to maintain the weight and immune function of patients with nasopharyngeal carcinoma during concurrent chemoradiotherapy, reduce the degree of treatment-related side effects during concurrent chemoradiotherapy for nasopharyngeal carcinoma, and delay the occurrence of acute side effects. The purpose of this study was to investigate the effect of rapid rapid rapid improvement of patients' immune status during concurrent chemoradiotherapy, and to further evaluate its impact on patients' weight, prognosis, treatment-related toxic side effects, and quality of life. In this study, 109 patients with nasopharyngeal carcinoma who received concurrent chemoradiotherapy in our hospital are planned to be included, and all patients in this group will be given oral tachyphin at a standard dose from the first day of radiotherapy. The nutritional immune status of the patient was assessed at different points during the treatment period.

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Key information

Conditions

Nasopharyngeal Carcinoma (NPC) Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Location status: Recruiting

Location contact

yong Su, MD

CONTACT

[email protected]

CHINA/360100+13699526170

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Patients with nasopharyngeal carcinoma confirmed by histopathology;2.Clinical stage stage II-IVa,Concurrent chemoradiotherapy is included in the definitive treatment regimen;3.Age ≥ 18 years, male or female;4.PG-SGA score of 0-8 before radiotherapy;5.KPS score ≥ 60 or ECOG score ≤3;6.Nutritional supplementation can be given by mouth or enterally;7.Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies;8.Serum hemoglobin ≥ 90 g/L, platelet ≥ 100×109/L, absolute neutrophil count ≥ 1.5×109/L;9.serum creatinine ≤1.25 times ULN or creatinine clearance ≥60 mL/min;10.Serum bilirubin ≤ 1.5-fold ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5-fold ULN, and alkaline phosphatase ≤ 5-fold ULN.

Exclusion criteria

  • 1.Have a second primary tumor;2.Those who do not receive concurrent chemoradiotherapy;3.Comorbid diabetes mellitus, or history of severe endocrine and metabolic diseases;4.Those who are allergic to oral nutritional meal replacements.

Treatment and study plan

Rapid glitter

Other

Patients with nasopharyngeal carcinoma are given rapid gamin during concurrent chemoradiotherapy

Primary outcomes

  1. Decreased proportion of immune cell subsets

    Time frame: 2 weeks

    The proportion of immune cell subsets that decline during chemoradiotherapy, including CD3, CD4, CD8

Secondary outcomes

  1. Change in the patient's weight

    Time frame: 2 weeks

    Change in the patient's weight during concurrent chemoradiotherapy

  2. Disease Free Survival

    Time frame: 3 Years

    DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death

Study contacts

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

Yong Su, MD

CONTACT

[email protected]

CHINA/360100+13699526170

Sponsors and collaborators

Lead sponsor

Jiangxi Provincial Cancer Hospital

Other

Registry information

Official study title

Nutritional Management During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Has an Impact on Immunonutritional Status and Therapeutic Phase Toxicity and Prognostic Effects

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jul 25, 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.

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