Head and Neck Cancer Clinical Trial
Official title:
Feasibility Study of a Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation
Verified date | October 2020 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 19 |
Est. completion date | October 6, 2020 |
Est. primary completion date | October 6, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of Hatha yoga | Number of adverse events as graded by CTCAE 4.0 | Approximately 8 weeks | |
Primary | 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 |
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