Clinical trial NCT03010150: Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
Official title: Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma of Unknown Primary
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Metastatic Head and Neck Carcinoma
Metastatic Malignant Neoplasm in the Uterine Cervix
Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Stage I Hypopharyngeal Carcinoma AJCC v8
Stage I Nasopharyngeal Carcinoma AJCC v8
Stage II Hypopharyngeal Carcinoma AJCC v8
Stage II Laryngeal Cancer AJCC v8
Stage II Nasopharyngeal Carcinoma AJCC v8
Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage III Hypopharyngeal Carcinoma AJCC v8
Stage III Laryngeal Cancer AJCC v8
Stage III Nasopharyngeal Carcinoma AJCC v8
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IV Hypopharyngeal Carcinoma AJCC v8
Stage IV Laryngeal Cancer AJCC v8
Stage IV Nasopharyngeal Carcinoma AJCC v8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVA Hypopharyngeal Carcinoma AJCC v8
Stage IVA Laryngeal Cancer AJCC v8
Stage IVA Nasopharyngeal Carcinoma AJCC v8
Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVB Hypopharyngeal Carcinoma AJCC v8
Stage IVB Laryngeal Cancer AJCC v8
Stage IVB Nasopharyngeal Carcinoma AJCC v8
Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-04
Enrollment: 471
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 with head and neck cancer

Brief summary: This trial uses blood tests and questionnaires to study how well participants with head and neck cancer that has spread to other places in the body adhere to swallowing exercises to prevent future disease. Using blood tests to study cytokines (proteins related to the immune system) may help doctors learn if certain levels of cytokines affect whether or not side effects occur and if they put participants at risk for future disease. Questionnaires may help doctors learn about the reasons head and neck cancer participants may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments.

Detailed description: PRIMARY OBJECTIVES:

I. To determine whether illness perceptions significantly predict adherence to swallowing exercises at 6 months after the end of radiation.

II. To determine whether sickness behaviors (depression, fatigue, pain)'s effect on illness perceptions are mediated by pro-inflammatory cytokines.

III. To determine whether social support moderates the impact of coping on appraisal of coping.

SECONDARY OBJECTIVES:

I. As a secondary aim, to determine the feasibility and utility of cardiac impedance pre-ejection period measurement as a corollary measure for depression and distress.

II. As a secondary aim, to identify potential genetic markers for swallowing dysfunction which has developed by the 6-month follow-up.

OUTLINE:

Participants provide blood samples prior to and at the 6-month visit after receiving radiation therapy. Participants also complete questionnaires either at home, in clinic, or via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood sample collection.

After completion of study, participants are followed up periodically for up to 2 years.

Eligibility 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)

Primary outcomes:
measure: Adherence to swallowing exercises
timeFrame: Up to 6 months
measure: Illness perceptions
timeFrame: Up to 6 months
measure: Effect of social support on coping
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eileen H Shinn
role: PRINCIPAL_INVESTIGATOR
References: