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

The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy: A Single-center, Phase II, Randomized Trial

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

Study Overview

• Status: Recruiting
• Conditions: GM-CSF
• Intervention / Treatment: Drug: GM-CSF

Detailed Description

Patients of GM-CSF group receive GM-CSF washmouth four times a day during radiotherapy. Control arm receive conventioanl care during radiotherapy. Visual signs of radiation or chemotherapy-induced mucosal damage were independently assessed during the course of RT by a radiation oncologist or other trained study personnel. The incidence of severe oral mucositis, the severe oral mucositis last time, quality of life between the two arms would be calculated.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiu Yan Chen, Dr; Phone Number: 020-87343380; Email: chenqy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Qiu-Yan Chen, Dr.; Phone Number: 020-87343380; Email: chenqy@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GM-CSF group; Patients use GM-CSF mouthwash four times per day during radiotherpay.	Drug: GM-CSF; GM-CSF mouthwash four times per day at radiotherapy initiate, during the whole radiotherapy phase
No Intervention: Convertional care group; Patients receive convertional care during radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute toxicities	The incidence rates of acute toxicities during treatment, evaluted by CTCAE Version5.0.	One month.
The last time of ≥3 grade oral mucositis	The time from first observed ≥3 grade oral mucositis to first observed oral mucositis decrease to less than grade 3	1 months after radiotherapy
Daily questionaire of oral mucositis (OMDQ)	Patients are required to finish daily questionaire of oral mucositis by visual signs	1 months after radiotherapy
Quality of life(QOL)	QOL is calculated by QLQ-C30.	1 months after radiotherapy

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Chair: Qiu Yan Chen, Dr, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 23, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: GM-CSF; Nasopharyngeal Carcinoma; oral mucositis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Mucositis; Stomatitis
• Other Study ID Numbers: GM-CSF for OM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No