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Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03010150
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

January 3, 2017
January 4, 2017
February 16, 2018
December 2016
December 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03010150 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
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.

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.

Questionnaire:

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood (about 1-2 teaspoons each time) drawn at two different times to measure the level of cytokines.
Non-Probability Sample
Participants with head and neck cancer who are starting radiation treatment at M. D. Anderson Cancer Center (MDACC).
  • Malignant Neoplasms of Lip Oral Cavity and Pharynx
  • Head and Neck Cancer
  • 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.
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.
Interventions:
  • Behavioral: Questionnaire
  • Procedure: Blood Draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
Same as current
December 2020
December 2019   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Eileen H. Shinn, PHD, MS, BA 713-745-0870
United States
 
 
NCT03010150
2016-0597
R21DE019954-01 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
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
M.D. Anderson Cancer Center
February 2018