Bioelectrical Impedance Analysis for Head and Neck Cancer

Overseen by Clifton D. Fuller

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

Bioelectrical impedance analysis measures body mass (the amount of muscle and fat in the body) and the level of hydration to help researchers identify patients who are losing muscle mass during radiation therapy. This information may help researchers make decisions about nutritional supplementation and the placement of feeding tubes in patients receiving radiation therapy.

Research Team

Clifton D. Fuller

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Histologically documented head and neck cancer (clinical stage I-IVB; Tx,1-4, N0-3)

Patients dispositioned to receive radiation therapy (dose >= 60 gray [Gy])

Patient received staging positron emission tomography/computed tomography (PET/CT) scan during 60-day period prior to initiating therapy

Exclusion Criteria

Previous radiation treatment for head and neck mucosal primary cancers (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)

Patients with pacemaker, implanted cardiac defibrillator, or vagal nerve stimulator

Pregnant or breast-feeding females

Treatment Details

Interventions

• Bioelectric Impedance Analysis (Procedure)

Trial Overview 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.

Participant Groups

Group I: Supportive Care (bioelectrical impedance analysis, RT) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School