Bioelectrical Impedance Analysis for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pacemaker, Pregnant, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Bioelectric Impedance Analysis for head and neck cancer?

Bioelectrical Impedance Analysis (BIA) is effective in assessing the nutritional status and body composition of head and neck cancer patients, which is crucial since malnutrition is common and affects treatment outcomes. BIA helps identify high-risk patients and monitor changes after surgery or during radiotherapy, potentially improving patient management and prognosis. ^{1 2 3 4 5}

Is bioelectrical impedance analysis safe for humans?

Bioelectrical impedance analysis (BIA) is generally considered safe for humans and is used to assess body composition and nutritional status, especially in patients with conditions like head and neck cancer. ^{1 2 3 4 5}

How does bioelectrical impedance analysis differ from other treatments for head and neck cancer?

Bioelectrical impedance analysis (BIA) is unique because it is not a direct treatment for head and neck cancer, but rather a method to assess body composition and nutritional status, which can be crucial for managing the condition. Unlike traditional treatments like surgery or chemotherapy, BIA helps identify malnutrition and body composition changes, providing valuable prognostic information to improve patient care. ^{1 2 3 4 5}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care radiation therapy

6-7 weeks

Weekly visits (in-person)

Post-Treatment Assessment

Participants undergo bioelectrical impedance analysis at 10-12 weeks after completion of radiation therapy

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored every 3 months for 2 years to assess long-term outcomes and body composition changes

2 years

Quarterly visits (in-person)

Treatment Details

Interventions

• Bioelectric Impedance Analysis

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Validity of bioelectrical impedance analysis to assess fat-free mass in patients with head and neck cancer: an exploratory study. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A bioimpedance analysis of head-and-neck cancer patients undergoing radiotherapy. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Can Bioelectrical Impedance Analysis and BMI be a Prognostic Tool in Head and Neck Cancer Patients? A Review of the Evidence. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Bioelectrical impedance analysis of head and neck cancer patients at presentation. [2017]

5. Poland pubmed.ncbi.nlm.nih.gov

Application of bioelectrical impedance analysis in monitoring patients with head and neck cancer after surgical intervention. [2023]