Recruiting

IMPT & TORS

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02663583

Conditions

Cancer of the Mouth

Oropharynx Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Symptom Questionnaires

Dysphagia Inventory Questionnaire

Activity Bands

Study Details

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.

Conditions

Cancer of the Mouth

Oropharynx Squamous Cell Carcinoma

Study ID

NCT02663583

Start date

Jan, 2016

Status verified date

May, 2019

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Symptom Questionnaires

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 Questionnaire

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 Bands

Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Neil Gross, MD

713-792-6920ngross@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

MD Anderson Health Information Specialist

877-632-6789

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 23, 2019

Last verified

May, 2019

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2019-05-23.