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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help researchers understand how radiation therapy affects muscle mass and hydration levels in patients with head and neck cancer. Using bioelectrical impedance analysis, a method to measure body composition, the trial will assess body fat, muscle, and water content. This information could guide decisions on nutritional support and the use of feeding tubes. The trial seeks participants diagnosed with head and neck cancer who are scheduled to receive radiation therapy. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance nutritional care for future patients.

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 prior data suggests that bioelectrical impedance analysis is safe for patients undergoing radiation therapy?

Research has shown that bioelectrical impedance analysis (BIA) is a safe method for assessing body composition and hydration in patients with head and neck cancer. Many studies have used BIA with these patients to monitor changes in body tissue, and no harmful effects have been reported.

This technique is non-invasive, meaning it doesn't involve surgery or entering the body. Patients simply stand on a scale or hold electrodes while a small, painless electrical current passes through the body. This process measures levels of fat, muscle, and water. Since BIA is already used in other areas of healthcare, it has a good safety record.

Overall, BIA is well-tolerated and has not shown any serious side effects in patients with head and neck cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about bioelectrical impedance analysis (BIA) for head and neck cancer because it offers a non-invasive way to monitor patients' body composition and hydration levels during radiation therapy. Unlike traditional methods that often rely on imaging and lab tests, BIA uses a technique that sends a small electrical current through the body to provide real-time data on changes in body composition. This can help doctors more quickly and effectively adjust treatment plans to improve patient outcomes. Additionally, BIA is simple to perform and can be done frequently without discomfort, potentially leading to more personalized and responsive care.

What evidence suggests that bioelectrical impedance analysis is effective for identifying muscle mass loss in head and neck cancer patients?

Studies have shown that bioelectrical impedance analysis (BIA) is useful for assessing body composition and nutrition in patients with head and neck cancer. Research indicates that BIA can detect muscle loss and poor nutrition in patients undergoing radiation therapy. In one study, BIA measurements provided important information about muscle changes, which helped guide nutrition plans. Another study found that BIA could predict patient outcomes during treatment. Overall, BIA has shown promise in improving care by identifying patients who may need extra nutritional support. Participants in this trial will undergo BIA as part of their supportive care regimen, alongside standard radiation therapy, to monitor these factors. ^{3 6 7 8 9}

Who Is on the Research Team?

Clifton D. Fuller

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8205950/

Bioelectrical impedance analysis as a quantitative ... This prospective observational study enrolled 50 patients with head and neck cancer undergoing radiation therapy. Baseline BIA measures of skeletal muscle (SM) ...

2. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1335052/full

Prognostic value of bioelectrical impedance analysis in ... Prognostic value of bioelectrical impedance analysis in head and neck cancer patients undergoing radiotherapy: a VALOR® study

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10675768/

Bioelectrical Impedance Analysis (BIA) for the Assessment of ... Bioelectrical impedance analysis in patients undergoing major head and neck surgery: a prospective observational pilot study.

4. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/full/10.1002/oto2.70046

Bioelectrical‐Impedance‐Analysis in the Perioperative ... BIA shows promise as a preoperative tool, in conjunction with SGA, to detect malnutrition in patients undergoing surgery for head-and-neck malignancies.

5. withpower.com withpower.com/trial/early-phase-1-head-and-neck-neoplasms-10-2015-1d356

Bioelectrical 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6023554/

A bioimpedance analysis of head-and-neck cancer ... The goal of the present study was to evaluate the relationship between Φ, time, intracellular water content, and weight for head-and-neck cancer patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7139769/

Can Bioelectrical Impedance Analysis and BMI Be a ... Bioimpedance Analysis Data on Head and Neck Cancer. Four studies have evaluated the changes in the tissue electrical properties of HNC patients (Table 4) ...

8. mdpi.com mdpi.com/2072-6643/15/22/4792

Bioelectrical Impedance Analysis (BIA) for the Assessment ... Bioelectrical impedance analysis in patients undergoing major head and neck surgery: a prospective observational pilot study.

9. otolaryngologypl.com otolaryngologypl.com/article/161853/en

Application of bioelectrical impedance analysis in ... Introduction: It is estimated that about 60% of patients with head and neck cancer (HNC) show poor nutritional status, and approximately 80% lose weight during ...