Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03010150
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : February 16, 2018
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn about the reasons head and neck cancer patients may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments. Researchers also want to learn if certain levels of cytokines affect if participant has side effects and if it puts participant at risk for future disease. Cytokines are proteins that are related to the immune system.

Condition or disease Intervention/treatment
Malignant Neoplasms of Lip Oral Cavity and Pharynx Head and Neck Cancer Behavioral: Questionnaire Procedure: Blood Draw

Detailed Description:

If participant agrees to take part in this study, participant will complete the below study tests at participant's first study visit and about 6 months after participant's radiation treatment.


Participant will complete a questionnaire (either in the clinic or at home) about how well participant is following the swallowing exercises and how participant has been coping with stress. The questionnaire will also collect information about the disease and personal information about participant, such as participant's age, sex, race, education level, and marital status. This questionnaire should take about 30 minutes to complete. On the Day 1 visit, participant will not complete the part of the questionnaire that asks about participant's swallowing exercises.

If participant prefers to complete the questionnaire online, a separate email will be sent to participant's email address. The email will contain a link to a secure online questionnaire protected by MD Anderson.

Cytokine Blood Tests:

Blood (about 1-2 teaspoons each time) will be drawn to measure the level of cytokines in participant's blood 2 times. These blood samples will be drawn at the same time as other routine blood draws so participant will not have extra needle sticks.

Researchers want to learn 1) if cytokine levels are related to changes in the types of side effects participant may have, such as fatigue and nausea, 2) which patients are at risk for developing permanent swallowing dysfunction after radiation treatment, and 3) which patients are at risk for developing recurrence after treatment.

Researchers will also study participant's genetic code to try to predict cytokine levels or what side effects participant may have. This means researchers may need to store parts of participant's blood for a long time, maybe with no time limit, to complete the genetic testing. However, these samples will only be used for research testing as described in this consent form.

Length of Study:

Participant's active participation in this study will be over after participant completes the 6 month questionnaire and blood draw.

Information from participant's medical record (such as information about participant's disease history, if the disease has gotten worse, any treatment participant receives, and any side effects participant has) will continue to be collected for up to 2 years after participant completes radiation therapy.

This is an investigational study.

Up to 230 participants will be enrolled in this study. All will take part at MD Anderson.

Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Head and Neck Cancer Group Adherence to Swallowing Exercises
Questionnaire completed at baseline and 6 months after radiation therapy. Blood drawn to measure the level of cytokines in blood at baseline and 6 months after radiation therapy.
Behavioral: Questionnaire

Participants complete an assessment questionnaire at baseline.

Six months after radiation therapy, participant completes another assessment questionnaire that will also ask about adherence to swallowing exercises.

Other Name: Survey
Procedure: Blood Draw
Blood (about 1-2 teaspoons each time) drawn to measure the level of cytokines in participant's blood at baseline, and 6 months after radiation therapy.

Primary Outcome Measures :
  1. Adherence to Swallowing Exercises Due to Illness Perceptions [ Time Frame: 6 months ]
    Participant's illness perception subscale scores', and relationship to adherence to swallowing exercises estimated using a linear mixed model.

Biospecimen Retention:   Samples With DNA
Blood (about 1-2 teaspoons each time) drawn at two different times to measure the level of cytokines.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with head and neck cancer who are starting radiation treatment at M. D. Anderson Cancer Center (MDACC).

Inclusion Criteria:

  1. Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases.
  2. Are stage II-IVb for non- HPV- related oropharyngeal cancer
  3. Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant metastasis or have HPV- related oropharynx cancer that is at least T2 with with no distant metastasis
  4. Are stage II-IVb for laryngeal cancer
  5. Are stage I-IVb for hypopharyngeal
  6. Are stage I-IVb for nasopharyngeal cancer
  7. Have stage I-III unknown primary cancer with cervical
  8. At least 18 years of age

Exclusion Criteria:

  1. Have other cancer diagnoses, except non-melanoma skin cancer
  2. Had treatment for previous head and neck cancer or radiation to the head and neck
  3. Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
  4. Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03010150

Contact: Eileen H. Shinn, PHD, MS, BA 713-745-0870

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Eileen H. Shinn, PHD, MS, BA M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT03010150     History of Changes
Other Study ID Numbers: 2016-0597
R21DE019954-01 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of lip oral cavity and pharynx
Head and Neck Cancer
Nasopharyngeal cancer
Oropharyngeal cancer
Hypopharyngeal cancer
Laryngeal cancer
Unknown primary cancer with cervical metastases
Blood draw

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lip Neoplasms
Neoplasms by Site
Mouth Neoplasms
Lip Diseases
Mouth Diseases
Stomatognathic Diseases