Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07085988

Nutritional Management During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: Impact on Immune Status, Treatment Toxicity, and Prognosis

Led by Jiangxi Provincial Cancer Hospital · Updated on 2025-07-25

109

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Nasopharyngeal carcinoma (NPC) is a cancer that develops in the lining of the nasopharynx. Malnutrition is a common complication in NPC patients, especially those receiving concurrent chemoradiotherapy, which can affect their prognosis. This trial is studying the impact of nutritional management on immune status, weight, treatment side effects, and quality of life in NPC patients undergoing concurrent chemoradiotherapy. Participants in this study will receive an immune-enhancing oral nutritional supplement called Rapid glitter starting from the first day of their radiotherapy. The study is designed to assess how this nutritional support affects patients during their chemoradiotherapy treatment course. The study is non-randomized and involves giving all patients the supplement while monitoring their condition. Throughout the treatment period, researchers will evaluate patients' immune nutritional status at various points. They will track changes in immune cell populations, weight, treatment-related toxicities, and quality of life. The primary outcome is the decrease in certain immune cell subsets after 2 weeks, with secondary outcomes including weight change at 2 weeks and disease-free survival over 3 years. Participants will be involved in regular assessments during and after treatment to monitor these outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with nasopharyngeal carcinoma confirmed by histopathology
  • Clinical stage II-IVa and receiving concurrent chemoradiotherapy as part of definitive treatment
  • Age 18 years or older, any gender
  • PG-SGA score between 0 and 8 before radiotherapy
  • KPS score 60 or higher or ECOG score 3 or lower
  • Able to receive nutritional supplementation orally or enterally
  • Signed informed consent form
  • Serum hemoglobin 90 g/L or higher, platelet count 100 x 10^9/L or higher, absolute neutrophil count 1.5 x 10^9/L or higher
  • Serum creatinine less than or equal to 1.25 times the upper limit of normal or creatinine clearance 60 mL/min or higher
  • Serum bilirubin less than or equal to 1.5 times the upper limit of normal; AST and ALT less than or equal to 2.5 times the upper limit of normal; alkaline phosphatase less than or equal to 5 times the upper limit of normal
Not Eligible

You will not qualify if you...

  • Presence of a second primary tumor
  • Not receiving concurrent chemoradiotherapy
  • Comorbid diabetes mellitus or history of severe endocrine and metabolic diseases
  • Allergy to oral nutritional meal replacements

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 weeks

Participants receive nutritional management during concurrent chemoradiotherapy for nasopharyngeal carcinoma.

Multiple visits during concurrent chemoradiotherapy

Trial Site Locations

Total: 1 location

1

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Actively Recruiting

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Research Team

Y

Yong Su, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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