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Bioelectrical Impedance Analysis for Head and Neck Cancer
N/A
Waitlist Available
Led By Clifton D Fuller
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial measures body mass (muscle and fat) and hydration levels to help researchers identify patients losing muscle mass during radiation therapy. This may help researchers make decisions about nutritional supplementation and feeding tube placement for patients receiving radiation therapy.
Who is the study for?
This trial is for patients with stage I-IV head and neck cancer who are set to undergo radiation therapy. They must have had a PET/CT scan within the last 60 days and women should test negative for pregnancy. It's not open to those who've had previous radiation for these cancers, have certain implants, are pregnant or breastfeeding, weigh over 660 lbs, or have conditions causing muscle loss.Check my eligibility
What is being tested?
The study tests how well bioelectrical impedance analysis can track body composition changes in patients undergoing radiation therapy. The goal is to better understand muscle mass loss during treatment which could influence nutritional support decisions.See study design
What are the potential side effects?
While this trial focuses on measuring body composition rather than testing a drug, side effects may arise from standard treatments like radiation therapy which can include skin irritation, fatigue, dry mouth, difficulty swallowing and potential nutritional deficiencies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lean and Fat Body Mass Composition from SECA mBCA BIA Scale Compared with Computed Tomography (CT) in Participants with Head and Neck Cancer Undergoing Radiation Therapy (RT)
Secondary outcome measures
BIA-derived body composition calculations
Other outcome measures
Bioelectrical impedance analysis (BIA) estimates of total body water
Lean body mass as a predictor of sarcopenia
Lean body mass as a predictor of therapeutic feeding tube use
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (bioelectrical impedance analysis, RT)Experimental Treatment6 Interventions
Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Bioelectric Impedance Analysis
2012
Completed Phase 2
~120
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,752 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,617 Total Patients Enrolled
Clifton D FullerPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
103 Total Patients Enrolled
Frequently Asked Questions
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