Not provided
Not provided
Not provided
Not provided
Not provided
COVID-19
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video and Written Yoga Instruction | Experimental | Videos and written instructions on Hatha yoga will be provided |
|
| Video, Written Yoga Instruction Plus Guided Yoga Sessions | Experimental | Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga Video | Behavioral | A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Hatha yoga | Number of adverse events as graded by CTCAE 4.0 | Approximately 8 weeks |
| Feasibility of Hatha yoga | 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) | Approximately 8 weeks |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barbara Murphy, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Posture and Strengthening Video | Behavioral | 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. |
|
| Relaxation Video | Behavioral | The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes |
|
| Breath Work Video | Behavioral | The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes. |
|
| Satisfaction Survey | Behavioral | Participants will complete a questionnaire addressing satisfaction with the yoga program. |
|
| Guided Yoga Session | Behavioral | Instructor guided yoga session twice a week |
|
| Written Yoga Instructions | Behavioral | Introduction to Yoga and Yoga poses |
|
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011187 | Posture |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided