Head and Neck Cancer
Conditions
Brief summary
This is a randomized prospective pilot study assessing the safety and feasibility of two yoga interventions in head and neck cancer patients undergoing primary or adjuvant radiation with or without concurrent chemotherapy
Detailed description
Primary Objective: \- To assess the safety and feasibility of Hatha yoga in head and neck cancer patients undergoing treatment with primary or adjuvant radiation with or without chemotherapy.
Interventions
BEHAVIORALYoga Video
A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.
BEHAVIORALPosture and Strengthening Video
The strengthening video directs patients through a sequence of isometric exercises to strengthen neck, shoulder and core muscles that are critical for good posture and musculoskeletal integrity. The patient may opt to do the strengthening exercises standing, sitting or with their back on the floor depending on their strength. The video lasts 20 minutes.
BEHAVIORALRelaxation Video
The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes
BEHAVIORALBreath Work Video
The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.
BEHAVIORALSatisfaction Survey
Participants will complete a questionnaire addressing satisfaction with the yoga program.
BEHAVIORALGuided Yoga Session
Instructor guided yoga session twice a week
BEHAVIORALWritten Yoga Instructions
Introduction to Yoga and Yoga poses
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Locally advanced, non-metastatic, histologically confirmed malignancy involving the head and neck region o Larynx, pharynx, oral cavity, salivary gland, paranasal sinuses and unknown primary * Age greater or equal to 21 years of age * Planned for either definitive or adjuvant radiation therapy with or without chemotherapy o Patients may have received induction chemotherapy or primary surgical resection prior to proceeding to radiation therapy * Ability to understand English * Daily access to the internet * Willing and able to sign informed consent * Willing and able to participate in yoga sessions as outlined in the study protocol
Exclusion criteria
* Prior head and neck cancer radiation * Patients who in the opinion of the treating physician are physically, medically or psychologically impaired to the point that participation is not deemed appropriate or feasible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Hatha yoga | Approximately 8 weeks | Number of adverse events as graded by CTCAE 4.0 |
| Feasibility of Hatha yoga | Approximately 8 weeks | At least 50% of patients will need to moderately compliant to be feasible (Compliance will be defined as:Fully Compliant: Participation in at least 1 yoga activity on at least 70% of days on study; Moderately Compliant: Participation in at least 1 yoga activity on at least 40% of days on study;Noncompliant: Participation on less than 40% of days on study) |
Countries
United States
Outcome results
None listed