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Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation
Feasibility Study of a Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation
1 other identifier
interventional
19
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable head-and-neck-cancer
Started Oct 2019
Shorter than P25 for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2019
CompletedFirst Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2020
CompletedOctober 8, 2020
October 1, 2020
11 months
October 29, 2019
October 6, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Video and Written Yoga Instruction
EXPERIMENTALVideos and written instructions on Hatha yoga will be provided
Video, Written Yoga Instruction Plus Guided Yoga Sessions
EXPERIMENTALVideos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided
Interventions
A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.
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.
The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes
The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.
Participants will complete a questionnaire addressing satisfaction with the yoga program.
Instructor guided yoga session twice a week
Introduction to Yoga and Yoga poses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Murphy, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sponsor Investigator
Study Record Dates
First Submitted
October 29, 2019
First Posted
October 31, 2019
Study Start
October 28, 2019
Primary Completion
October 6, 2020
Study Completion
October 6, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share