Management of chemo/radiation-induced oral mucositis in patients with head and neck cancer: A review of the current literature.
Dariush Moslemi, Akram Mohammadi Nokhandani, Mahsa Taheri Otaghsaraei...
https://pubmed.ncbi.nlm.nih.gov/27113797Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05892354
Efficacy of Immunonutrients in Reducing Oral Mucositis in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multicenter, Randomized Controlled Clinical Trial
Led by First Affiliated Hospital of Guangxi Medical University · Updated on 2024-08-07
190
Participants Needed
20
Research Sites
100 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Guangxi Medical University
Lead Sponsor
G
Guangdong Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess whether immunonutrition can reduce oral mucositis compared with standard nutrition in patients with locally advanced nasopharyngeal carcinoma receiving chemoradiotherapy. Oral mucositis is a common and severe side effect in these patients, causing pain, difficulty swallowing, and malnutrition, which can disrupt treatment and worsen quality of life and prognosis. Nutritional interventions like immunonutrition may help improve immune response, reduce inflammation, and enhance treatment tolerance and outcomes. Participants receive induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy with intensity-modulated radiotherapy and cisplatin. They are randomly assigned to one of two groups: one group receives enteral immunonutrition (Oral Impact®) twice daily starting 5 days before radiotherapy until treatment ends, while the other group receives a standard enteral nutrition formula (ENSURE®) three times daily over the same period. During the study, participants are monitored for the incidence, timing, and duration of severe oral mucositis over 7 weeks. Researchers also assess immune status, inflammatory markers, nutritional and physical function, quality of life, and survival rates up to 2 years after randomization. Safety and adverse events are recorded throughout the study. Participants are expected to follow scheduled visits, laboratory tests, and questionnaires.
CONDITIONS
Brief Title
Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age between 18 and 70 years, male or non-pregnant female
- Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (WHO type II or III)
- Newly diagnosed stage III-IVa nasopharyngeal carcinoma
- Adequate organ function meeting specified blood, liver, kidney, coagulation, and cardiac enzyme levels
- Signed informed consent and ability to comply with study visits, treatments, and tests
You will not qualify if you...
- Use of Oral Impact® or ENSURE® within one month before enrollment
- Allergy or intolerance to components of Oral Impact®, ENSURE®, or related chemotherapy drugs
- Poor glycemic control in diabetes
- Autoimmune diseases
- Active infections
- Previous radiation therapy or other antitumor treatments
- History of other malignant tumors
- Presence of oral mucositis or malnutrition at baseline
- Inability to eat required food amounts or soft solid foods at baseline
- History of HIV or active hepatitis B/C infection
- Participation in other intervention studies within one month
- Other serious illnesses or conditions affecting safety or data collection as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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 7 weeks
Participants receive induction chemotherapy followed by concurrent chemoradiotherapy. They also take either enteral immunonutrition or standard enteral nutrition starting 5 days before radiotherapy and continuing until the end of radiotherapy.
Multiple visits during chemotherapy and radiotherapy over 7 weeks
Follow-up
Duration - Up to 2 years after randomization
Participants are monitored for immune state, nutritional status, quality of life, and survival outcomes after completing treatment.
Periodic visits for assessments up to 2 years
Trial Site Locations
Total: 20 locations
1
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510060
Actively Recruiting
4
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China, 510070
Actively Recruiting
5
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China, 516001
Actively Recruiting
6
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
Actively Recruiting
7
Liuzhou Workers Hospital
Liuzhou, Guangxi, China, 545025
Actively Recruiting
8
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
Actively Recruiting
9
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China, 543002
Actively Recruiting
10
First People People's Hospital of Yulin City
Yulin, Guangxi, China, 537001
Actively Recruiting
11
Red Cross Hospital of Yulin City
Yulin, Guangxi, China, 537006
Actively Recruiting
12
Huizhou Municipal Central Hospital
Haikou, Hainan, China, 570208
Actively Recruiting
13
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 570311
Actively Recruiting
14
Hainan Cancer Hospital
Haikou, Hainan, China, 570314
Actively Recruiting
15
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Actively Recruiting
16
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330209
Actively Recruiting
17
Qingdao Central Hospital
Qingdao, Shandong, China, 266044
Actively Recruiting
18
Zhejiang Provincial Tongde Hospital
Hangzhou, Zhejiang, China, 310012
Actively Recruiting
19
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
20
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
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Research Team
Z
Zhen Meng, M.D
Y
Yating Qin, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Pierre Boisselier, Marie-Christine Kaminsky, Simon Thézenas...
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J Talvas, G Garrait, N Goncalves-Mendes...
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Tanadech Dechaphunkul, Tippawan Arundon, Ponpis Raungkhajon...
https://pubmed.ncbi.nlm.nih.gov/35007812