Cancer of the MouthNCT02663583
Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell
An observational study of Cancer of the Mouth and Oropharynx Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Mouth, Oropharynx Squamous Cell Carcinoma
- What is being tested?
- Symptom Questionnaires, Dysphagia Inventory Questionnaire and Activity Bands
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants having treatment with either proton therapy (called Intensity-Modulated Proton Therapy or IMPT) or robotic surgery (called TransOral Robotic Surgery or TORS) at MD Anderson Cancer Center in Houston, Texas.
Who may be able to join
- Age ≥ 18 years
- Histologically documented or suspected, previously untreated OPSCC (Clinical Stage I-Va; Tx,0-2, N0-2b) eligible for standard of care single-modality treatment with either IMPT or TORS. Patients with suspected OPSCC must have a diagnosis confirmed prior to treatment per the current clinical standard of care
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
MD Anderson Health Information Specialist, 877-632-6789
About this study
Official title: Observational Parallel Cohort Study of Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell Carcinoma
The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS.
Read the detailed description
Baseline Visit:
If participant agrees to take part in this study, they will complete the following tests and procedures at their baseline visit. This baseline visit will take place before participant's treatment with IMPT or TORS:
- Participant will complete questionnaires about any symptoms of cancer they may be having and how they affect their daily life at work and at home, their diet, and their speech.
- Participant will complete the Dysphagia Inventory. This is a questionnaire about how difficult it is to swallow.
- The study staff will measure how wide participant can open their jaw to see if their treatment may cause any jaw opening limitations.
It should take about 30 minutes to complete all of the questionnaires.
As part of participant's baseline visit, information below will be collected from their medical record:
- Participant's medical history
- The results of participant's physical exam including their weight and any recent weight loss.
- Any other diseases participant may have and any drugs they are currently taking.
- Participant's current smoking status and smoking history.
Activity Bands:
The study staff will either give participant an activity band at their baseline visit or they will be mailed an activity wristband. Participant will be asked to wear the band 24 hours a day for 1 week leading up to all study visits. The wristband will record how active participant is and how much they sleep. The study staff will show participant how to wear and use the wristband.
Study Visits:
Participant will complete the following study procedures after they complete treatment with either IMPT or TORS, and at 3 and 6 months after that.
- The data from participant's wristband will be collected.
- Participant will complete the same questionnaires they did at baseline.
- At participant's 3 month visit only, the study staff will measure how wide they can open their jaw to see if their treatment may cause any jaw opening limitations.
IMPT patients only:
If participant is receiving IMPT, they will complete the questionnaires they completed at the baseline visit once a week while they are receiving treatment.
Length of Study:
Participant's active participation in this study will be over after the 6 month study visit.
Participant will return the wristband to the study staff after their participation is over. If participant loses or damages the wristband while they are on study, another one will be provided to them at no cost.
This is an investigational study.
Up to 44 participants will take part in this study. All will be enrolled at MD Anderson.
- Being tested
- Symptom Questionnaires, Dysphagia Inventory Questionnaire, Activity Bands
- Keywords
- Oropharynx squamous cell carcinoma, OPSCC, Actigraph accelerometer, MD Anderson Symptom Inventory - Head and Neck module, MDASI-HN, Intensity-Modulated Proton Therapy, IMPT, TransOral Robotic Surgery, TORS, Surveys, Questionnaires
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom QuestionnairesBehavioural
Also called Surveys
Intensity-Modulated Proton Therapy or( IMPT) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months.
TransOral Robotic Surgery (TORS) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months.
Dysphagia Inventory QuestionnaireBehavioural
Also called Survey
Intensity-Modulated Proton Therapy or( IMPT) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months.
TransOral Robotic Surgery (TORS) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months.
Activity BandsBehavioural
Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
| Study group | Role | What they receive |
|---|---|---|
| Intensity-Modulated Proton Therapy or( IMPT) Group | Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months.
Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months.
Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits. Receives: Behavioral: Symptom Questionnaires; Behavioral: Dysphagia Inventory Questionnaire; Behavioral: Activity Bands | |
| TransOral Robotic Surgery (TORS) Group | Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months.
Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months.
Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits. Receives: Behavioral: Symptom Questionnaires; Behavioral: Dysphagia Inventory Questionnaire; Behavioral: Activity Bands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC)
Functional outcome measured by using longitudinal digital wristband activity monitoring of study participants.
Measured: 6 months
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC)
Functional outcome measured by using patient-reported outcome (PRO) measures from the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDADI-HN).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the MouthStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Gross, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663583
- Sponsor's protocol ID
- PA15-0744
- Status last verified
- May 2019
- First submitted
- 19 Jan 2016
- Last updated
- 23 May 2019
- 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 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Parallel Cohort Study of Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02663583
- Acronym / sponsor ID
- PA15-0744
- Keywords
- Oropharynx squamous cell carcinoma, OPSCC, Actigraph accelerometer, MD Anderson Symptom Inventory - Head and Neck module, MDASI-HN, Intensity-Modulated Proton Therapy, IMPT, TransOral Robotic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Jan 2016 (estimated)
- 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.
The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS.
Detailed description
Baseline Visit:
If participant agrees to take part in this study, they will complete the following tests and procedures at their baseline visit. This baseline visit will take place before participant's treatment with IMPT or TORS:
- Participant will complete questionnaires about any symptoms of cancer they may be having and how they affect their daily life at work and at home, their diet, and their speech.
- Participant will complete the Dysphagia Inventory. This is a questionnaire about how difficult it is to swallow.
- The study staff will measure how wide participant can open their jaw to see if their treatment may cause any jaw opening limitations.
It should take about 30 minutes to complete all of the questionnaires.
As part of participant's baseline visit, information below will be collected from their medical record:
- Participant's medical history
- The results of participant's physical exam including their weight and any recent weight loss.
- Any other diseases participant may have and any drugs they are currently taking.
- Participant's current smoking status and smoking history.
Activity Bands:
The study staff will either give participant an activity band at their baseline visit or they will be mailed an activity wristband. Participant will be asked to wear the band 24 hours a day for 1 week leading up to all study visits. The wristband will record how active participant is and how much they sleep. The study staff will show participant how to wear and use the wristband.
Study Visits:
Participant will complete the following study procedures after they complete treatment with either IMPT or TORS, and at 3 and 6 months after that.
- The data from participant's wristband will be collected.
- Participant will complete the same questionnaires they did at baseline.
- At participant's 3 month visit only, the study staff will measure how wide they can open their jaw to see if their treatment may cause any jaw opening limitations.
IMPT patients only:
If participant is receiving IMPT, they will complete the questionnaires they completed at the baseline visit once a week while they are receiving treatment.
Length of Study:
Participant's active participation in this study will be over after the 6 month study visit.
Participant will return the wristband to the study staff after their participation is over. If participant loses or damages the wristband while they are on study, another one will be provided to them at no cost.
This is an investigational study.
Up to 44 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensity-Modulated Proton Therapy or( IMPT) Group | – | Behavioral: Symptom Questionnaires, Behavioral: Dysphagia Inventory Questionnaire, Behavioral: Activity BandsSymptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months. Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months. Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits. |
| TransOral Robotic Surgery (TORS) Group | – | Behavioral: Symptom Questionnaires, Behavioral: Dysphagia Inventory Questionnaire, Behavioral: Activity BandsSymptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months. Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months. Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants having treatment with either proton therapy (called Intensity-Modulated Proton Therapy or IMPT) or robotic surgery (called TransOral Robotic Surgery or TORS) at MD Anderson Cancer Center in Houston, Texas.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Histologically documented or suspected, previously untreated OPSCC (Clinical Stage I-Va; Tx,0-2, N0-2b) eligible for standard of care single-modality treatment with either IMPT or TORS. Patients with suspected OPSCC must have a diagnosis confirmed prior to treatment per the current clinical standard of care
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Symptom QuestionnairesAlso: SurveysIntensity-Modulated Proton Therapy or( IMPT) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months. TransOral Robotic Surgery (TORS) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months. | Behavioural | Intensity-Modulated Proton Therapy or( IMPT) Group, TransOral Robotic Surgery (TORS) Group |
| Dysphagia Inventory QuestionnaireAlso: SurveyIntensity-Modulated Proton Therapy or( IMPT) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months. TransOral Robotic Surgery (TORS) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months. | Behavioural | Intensity-Modulated Proton Therapy or( IMPT) Group, TransOral Robotic Surgery (TORS) Group |
| Activity BandsActivity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits. | Behavioural | Intensity-Modulated Proton Therapy or( IMPT) Group, TransOral Robotic Surgery (TORS) Group |
Primary outcome
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC)
Time frame: 6 months
Functional outcome measured by using longitudinal digital wristband activity monitoring of study participants.
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC)
Time frame: 6 Months
Functional outcome measured by using patient-reported outcome (PRO) measures from the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDADI-HN).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Neil Gross, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Mouth and Oropharynx Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neil Gross, MD (713-792-6920, ngross@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 23 May 2019.