Studying how well head and neck cancer patients follow swallowing exercises after radiation
Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
M.D. Anderson Cancer Center · NCT03010150
This study looks at how well people with head and neck cancer stick to their swallowing exercises after radiation treatment and what factors might help or hinder them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 471 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03010150 on ClinicalTrials.gov |
What this trial studies
This observational study examines adherence to preventative swallowing exercises among participants with metastatic head and neck cancer. It utilizes blood tests to analyze cytokine levels and questionnaires to understand the factors influencing adherence to these exercises post-radiation therapy. The study aims to identify predictors of adherence, the role of illness perceptions, and the impact of social support on coping strategies. Participants will provide blood samples and complete questionnaires at specified intervals, with follow-up extending up to two years.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with metastatic head and neck cancer who are scheduled to receive radiation therapy.
Not a fit: Patients with other cancer diagnoses or those who have previously undergone treatment for head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve adherence to swallowing exercises, potentially reducing side effects and improving quality of life for patients with head and neck cancer.
How similar studies have performed: Other studies have shown success in using similar approaches to improve adherence to therapeutic exercises in cancer patients, indicating potential for this study's success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases * Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer * 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 no distant metastasis * Are stage II-IVb for laryngeal cancer * Are stage I-IVb for hypopharyngeal * Are stage I-IVb for nasopharyngeal cancer * Have stage I-III unknown primary cancer with cervical Exclusion Criteria: * Have other cancer diagnoses, except non-melanoma skin cancer * Had treatment for previous head and neck cancer or radiation to the head and neck * Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy) * Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Eileen H Shinn — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carcinoma of Unknown Primary, Clinical Stage I HPV-Mediated Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Carcinoma, Metastatic Malignant Neoplasm in the Uterine Cervix, Pathologic Stage I HPV-Mediated Oropharyngeal Carcinoma AJCC v8, Pathologic Stage II HPV-Mediated Oropharyngeal Carcinoma AJCC v8