to find the effectiveness of giving intravenous fluid as precaution on improving dehydration, decreasing treatment complications, and improving treatment completion rates in patients undergoing simultaneous chemotherapy and radiation therapy for head and neck cancer.
Phase 2
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/10/058708
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients receiving chemo-radiation therapy for head and neck cancers with curative intent.
Exclusion Criteria
Medical comorbidities like chronic kidney disease or congestive heart failure where fluid supplementation should be carefully done.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Completion of 5 or more cycles of concurrent chemoradiotherapy with no or less than 3 days of break. <br/ ><br>Timepoint: Weekly assessment during the course of RT
- Secondary Outcome Measures
Name Time Method a) Incidence of grade 3 radiation mucositis <br/ ><br>b) Time to onset of grade 3 radiation mucositis <br/ ><br>c) Duration of grade 3 radiation mucositis <br/ ><br>d) Requirement of NG/FG tube placement after initiation of treatment e) Incidence of radiation breaks of > 3 days due to morbidity <br/ ><br>f) Incidence of unplanned hospital admissionsTimepoint: Weekly assessment during the course of RT
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of prophylactic IV fluids in phase II head and neck cancer chemoradiotherapy trials?
How does prophylactic IV fluid administration compare to standard hydration protocols in reducing chemoradiotherapy complications for head and neck cancer?
Which biomarkers predict response to prophylactic IV fluids in head and neck cancer patients undergoing chemoradiotherapy?
What are the potential adverse events of daily prophylactic IV fluids in the CTRI/2023/10/058708 phase II head and neck cancer trial?
Are there combination therapies with IV fluids that improve treatment completion in head and neck cancer chemoradiotherapy?