The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients with Head and Neck Cancer Undergoing Radiation Therapy

January 22, 2025 updated by: Ravi Chandra, OHSU Knight Cancer Institute

Evaluation of the Use of "Smart" Body-Weight Scales in Patients with Head and Neck Cancer Undergoing Radiation Therapy

This clinical trial studies the use of "smart" body-weight scales to monitor weight and nutrition among patients with head and neck cancer undergoing radiation therapy. Malnutrition affects 30-50% of patients diagnosed with head and neck cancer, and approximately 30% of patients have malnutrition prior to diagnosis. "Smart" body weight scales can possibly make self-weighing easier, faster, and more accurate through weight recordings through mobile applications available for "smart" scales. This has the potential to maximize nutritional guidance through quick weight updates, possibly delaying or removing the use of patient enteral feeding (tube feeding). By avoiding or minimizing the use of enteral feeding during radiation therapy, the risk of long-term tube dependence and swallowing ability complications may be reduced.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the feasibility of "smart" body scales in patients undergoing radiation therapy for head and neck cancer.

SECONDARY OBJECTIVE:

I. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire, overall pain scores, and weight loss percentage.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I: Patients weigh themselves daily using the "Smart" scale over 5-8 weeks during standard radiation therapy.

COHORT II: Patients do not weigh themselves using the "Smart" scale during standard radiation therapy.

After completion of study intervention, patients are followed up within 2 weeks and 3 months post-radiation therapy.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Mid-Atlantic Permanente Medical Group
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Knight Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a histologically confirmed malignancy whereby pursual of radiation therapy has potential curative benefits for the patient.
  • Criteria for selection of head and neck malignancies include squamous cell carcinoma.
  • Ability to understand and the willingness to sign a written informed consent document.
  • For the intervention group, the ability to properly utilize a "smart" body weight scale after appropriate training has been provided. This includes access to wireless internet which can be paired with the "smart" body weight scale to transmit weight scale data.

Exclusion Criteria:

  • Do not meet the criteria for histologically confirmed malignancies.
  • Refuse or do not pursue radiation therapy for curative benefit of their malignancy.
  • Who do not understand or are unwilling to sign a written informed consent document.
  • For the intervention group, the inability to utilize or pair their "smart" body weight sales to wireless internet.
  • Members of vulnerable populations as below

  • Pregnant women, children, prisoners, neonates, and decisionally impaired adults will not be included in this study. Excluding vulnerable populations, all patients who are receiving or seeking medical care at Oregon Health & Science University (OHSU) for their head and neck cancer and meet inclusion criteria will be invited to participate in this study. Potential participants will be approached by a member of the clinic staff and will be asked to review a copy of the informed consent form prior to being seen by a treating physician. The investigator, or other qualified, designated healthcare provider will review the informed consent form with potential participants and address any questions or concerns prior to obtaining written informed consent for participation in this study. The investigator or other qualified, designated healthcare provider will also address any future questions or concerns of the participant.

    • Only individuals who have provided directly their written informed consent for participation in this study and meet inclusion criteria will be placed in the study. The participation of patients who are mentally incapacitated (e.g., comatose, unresponsive) will not be sought

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cohort 2 (no weighing)
Patients do not weigh themselves using the "Smart" scale during standard radiation therapy.
Other: Questionnaire Administration
Ancillary studies
Experimental: Cohort I ('Smart" scale weighing)
Patients weigh themselves daily using the "Smart" scale over 5-8 weeks during standard radiation therapy.
Other: Questionnaire Administration
Ancillary studies
Other: Medical Device Qardio® smart scale Usage and Evaluation
Weight monitored using a Qardio® smart scale
Other Names:
  • Smart body-weight scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to treatment
Time Frame: Up to 8 weeks
Will include continuous variables (number of times participant stepped on the scale). Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire scores
Time Frame: Baseline up to 3 months post-radiation therapy
The MDASI-HN has 13 core symptoms that is scored, at their worst over the last 24 hours, on a 0-10 numeric rating scale. A "0" means that a symptom is not present and a "10" is "as bad as you can imagine." Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Baseline up to 3 months post-radiation therapy
Overall pain scores
Time Frame: Up to 3 months post-radiation therapy
Pain scores will be on a numeric rating scale, with lower numbers indicating lower pain values. Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Up to 3 months post-radiation therapy
Weight loss percentage
Time Frame: Up to 3 months post-radiation therapy
Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Up to 3 months post-radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University
Cambia Health Foundation

Investigators

  • Principal Investigator: Ravi Chandra, OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2023

Primary Completion (Actual)

September 13, 2023

Study Completion (Actual)

September 13, 2023

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00022914 (OHSU Knight Cancer Institute)
  • NCI-2022-05054 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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