Using GM-CSF to prevent oral mucositis in nasopharyngeal carcinoma patients during radiotherapy
The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy: A Single-center, Phase II, Randomized Trial
This study is testing if a GM-CSF mouthwash can help prevent painful mouth sores in patients with nasopharyngeal cancer who are getting radiation treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06472739 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of GM-CSF in preventing oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy. Participants in the GM-CSF group will use a GM-CSF mouthwash four times daily during their treatment, while the control group will receive standard care. The study will assess the incidence and severity of oral mucositis, as well as the quality of life of participants, through independent evaluations by trained personnel. The goal is to determine if GM-CSF can significantly reduce the occurrence of this painful side effect of treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with histologically confirmed non-keratinizing nasopharyngeal carcinoma at clinical stages II-IVa, without distant metastasis.
Not a fit: Patients with distant metastasis or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of oral mucositis, improving the quality of life for patients undergoing treatment.
How similar studies have performed: Previous studies have shown promising results with GM-CSF in similar contexts, suggesting potential efficacy in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qiu Yan Chen, Dr
- Email: chenqy@sysucc.org.cn
- Phone: 020-87343380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.