Clinical trial NCT02663583: Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of the Mouth
Oropharynx Squamous Cell Carcinoma
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. 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
3. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2

Exclusion Criteria:

N/A

Primary outcomes:
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)
timeFrame: 6 months
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)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Neil Gross, MD
role: PRINCIPAL_INVESTIGATOR
References: