The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy

NCT06472739 | Recruiting Phase 2

• 1 other identifier: GM-CSF for OM
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.

Conditions

GM-CSF

Keywords

Nasopharyngeal Carcinoma; GM-CSF; oral mucositis

Outcome Measures

Primary Outcomes (1)

• The incidence of severe oral mucositis(grade 3+)

  To evaluate the incidence of severe oral mucositis between the two arms.

  During radiotherapy, up to 1.5 months.

Secondary Outcomes (4)

• Acute toxicities

  One month.

• The last time of ≥3 grade oral mucositis

  1 months after radiotherapy

• Daily questionaire of oral mucositis (OMDQ)

  1 months after radiotherapy

• Quality of life(QOL)

  1 months after radiotherapy

Study Arms (2)

GM-CSF group

EXPERIMENTAL

Patients use GM-CSF mouthwash four times per day during radiotherpay.

Drug: GM-CSF

Convertional care group

NO INTERVENTION

Patients receive convertional care during radiotherapy.

Interventions

GM-CSF DRUG

GM-CSF mouthwash four times per day at radiotherapy initiate, during the whole radiotherapy phase

GM-CSF group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, world health organization \[WHO\] II or III).
• b. Original clinical staged as II-IVa (according to the 8 th AJCC edition) c. Male or female who are not pregnant. d. No evidence of distant metastasis (M0). e. Age between 18-65 years. f. WBC≥4×109/L, PLT≥100×109/L, HGB≥90g/L. g. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
• i. With normal renal function test (creatinine clearance rate≥60 ml/min or creatinine\< 1.5×ULN.
• j. The Eastern Cooperative Oncology Group (ECOG) Performance status less or equal to 1.
• k. Patients must be informed of the investigational nature of this study and give written informed consent.
• l. Patients receive induction chemotherapy plus concurrent chemoradiotherpy or concurrent chemoradiotherapy, or radiotherapy alone.

You may not qualify if:

• Age \<18 or \>65years. c. With clinical stage of I or IVb (according to the 8 th AJCC edition). d. Patients with tumor recurrence or distant metastasis. e. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• f. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
• g. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
• h. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
• i. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and mental disturbance.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Stomatitis

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Qiu Yan Chen, Dr

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Qiu Yan Chen, Dr

CONTACT

020-87343380; chenqy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: June 25, 2024
• Study Start: September 15, 2023
• Primary Completion: August 15, 2024
• Study Completion: November 15, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)