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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

BIA-derived body composition calculations

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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