Head and Neck Squamous Cell CarcinomaNCT05457478
The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients With Head and Neck Cancer Undergoing Radiation Therapy
A study testing Medical Device Qardio® smart scale Usage and Evaluation and Questionnaire Administration in people with Head and Neck Squamous Cell Carcinoma and Malignant Head and Neck Neoplasm, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Malignant Head and Neck Neoplasm
- What is being tested?
- Medical Device Qardio® smart scale Usage and Evaluation and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2023to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Mid-Atlantic Permanente Medical Group
Rockville, Maryland, 20852
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of "smart" body scales in patients undergoing radiation therapy for head and neck cancer.
SECONDARY OBJECTIVE:
- 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.
- Being tested
- Medical Device Qardio® smart scale Usage and Evaluation, Questionnaire Administration
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Qardio® smart scale Usage and EvaluationOther
Also called Smart body-weight scale
Weight monitored using a Qardio® smart scale
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 (no weighing) | Active comparator | Patients do not weigh themselves using the "Smart" scale during standard radiation therapy. Receives: 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. Receives: Other: Medical Device Qardio® smart scale Usage and Evaluation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks
Secondary outcomes (3)
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire scores
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.
Measured: Baseline up to 3 months post-radiation therapy
Overall pain scores
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.
Measured: Up to 3 months post-radiation therapy
Weight loss percentage
Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Measured: Up to 3 months post-radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start13 Jan 2023
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Why it stopped: PI departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cambia Health Foundation, Oregon Health and Science University
- Responsible party
- Principal investigator, Ravi Chandra, OHSU Knight Cancer Institute
- Investigators
- Ravi Chandra, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457478
- Sponsor's protocol ID
- STUDY00022914
- Other IDs
- NCI-2022-05054, STUDY00022914
- Status last verified
- Jan 2025
- First submitted
- 1 Jul 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of "Smart" Body-Weight Scales in Patients With Head and Neck Cancer Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT05457478
- Acronym / sponsor ID
- STUDY00022914
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI departure
- Enrolment
- 2 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Cambia Health Foundation, Oregon Health and Science University
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of "smart" body scales in patients undergoing radiation therapy for head and neck cancer.
SECONDARY OBJECTIVE:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 (no weighing) | Active comparator | Other: Questionnaire AdministrationPatients do not weigh themselves using the "Smart" scale during standard radiation therapy. |
| Cohort I ('Smart" scale weighing) | Experimental | Other: Medical Device Qardio® smart scale Usage and Evaluation, Other: Questionnaire AdministrationPatients weigh themselves daily using the "Smart" scale over 5-8 weeks during standard radiation therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device Qardio® smart scale Usage and EvaluationAlso: Smart body-weight scaleWeight monitored using a Qardio® smart scale | Other | Cohort I ('Smart" scale weighing) |
| Questionnaire AdministrationAncillary studies | Other | Cohort 2 (no weighing), Cohort I ('Smart" scale weighing) |
Primary outcome
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.
3 secondary outcomes
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire scores
Time frame: Baseline up to 3 months post-radiation therapy
Overall pain scores
Time frame: Up to 3 months post-radiation therapy
Weight loss percentage
Time frame: Up to 3 months post-radiation therapy
Results and safety
The study was stopped early (reason given: PI departure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Chandra principal investigator
OHSU Knight Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device Qardio® smart scale Usage and Evaluation and Questionnaire Administration in people with Head and Neck Squamous Cell Carcinoma and Malignant Head and Neck Neoplasm, run by OHSU Knight Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI departure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to treatment (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.