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

NCT05457478 | Terminated

• 2 other identifiers: STUDY00022914NCI-2022-05054
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Malignant Head and Neck Neoplasm

Outcome Measures

Primary Outcomes (1)

• Adherence to treatment

  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 Outcomes (3)

• MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire scores

  Baseline up to 3 months post-radiation therapy

• Overall pain scores

  Up to 3 months post-radiation therapy

• Weight loss percentage

  Up to 3 months post-radiation therapy

Study Arms (2)

Cohort 2 (no weighing)

ACTIVE COMPARATOR

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

Other: Questionnaire Administration

Cohort I ('Smart" scale weighing)

EXPERIMENTAL

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

Other: Medical Device Qardio® smart scale Usage and Evaluation; Other: Questionnaire Administration

Interventions

Medical Device Qardio® smart scale Usage and Evaluation OTHER

Weight monitored using a Qardio® smart scale

Also known as: Smart body-weight scale

Cohort I ('Smart" scale weighing)

Questionnaire Administration OTHER

Ancillary studies

Cohort 2 (no weighing); Cohort I ('Smart" scale weighing)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Cambia Health Foundation: collaborator
• Oregon Health and Science University: collaborator

Study Sites (2)

Mid-Atlantic Permanente Medical Group

Rockville, Maryland, 20852, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Ravi Chandra

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 14, 2022
• Study Start: January 13, 2023
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

US (2)