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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2023-09-13

Brief Summary

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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.

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TERMINATED PHASE3

Detailed Description

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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.

Conditions

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Head and Neck Squamous Cell Carcinoma Malignant Head and Neck Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cohort 2 (no weighing)

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

Group Type ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Cohort I ('Smart" scale weighing)

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

Group Type EXPERIMENTAL

Medical Device Qardio® smart scale Usage and Evaluation

Intervention Type OTHER

Weight monitored using a Qardio® smart scale

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Medical Device Qardio® smart scale Usage and Evaluation

Weight monitored using a Qardio® smart scale

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Smart body-weight scale

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No