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Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146779
Recruitment Status : Terminated (COVID-19)
First Posted : October 31, 2019
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Behavioral: Yoga Video Behavioral: Posture and Strengthening Video Behavioral: Relaxation Video Behavioral: Breath Work Video Behavioral: Satisfaction Survey Behavioral: Guided Yoga Session Behavioral: Written Yoga Instructions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility Study of a Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation
Actual Study Start Date : October 28, 2019
Actual Primary Completion Date : October 6, 2020
Actual Study Completion Date : October 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Video and Written Yoga Instruction
Videos and written instructions on Hatha yoga will be provided
Behavioral: Yoga Video
A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.

Behavioral: Posture 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.

Behavioral: Relaxation Video
The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes

Behavioral: Breath Work Video
The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.

Behavioral: Satisfaction Survey
Participants will complete a questionnaire addressing satisfaction with the yoga program.

Behavioral: Written Yoga Instructions
Introduction to Yoga and Yoga poses

Experimental: Video, Written Yoga Instruction Plus Guided Yoga Sessions
Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided
Behavioral: Yoga Video
A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.

Behavioral: Posture 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.

Behavioral: Relaxation Video
The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes

Behavioral: Breath Work Video
The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.

Behavioral: Satisfaction Survey
Participants will complete a questionnaire addressing satisfaction with the yoga program.

Behavioral: Guided Yoga Session
Instructor guided yoga session twice a week

Behavioral: Written Yoga Instructions
Introduction to Yoga and Yoga poses




Primary Outcome Measures :
  1. Safety of Hatha yoga [ Time Frame: Approximately 8 weeks ]
    Number of adverse events as graded by CTCAE 4.0

  2. Feasibility of Hatha yoga [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146779


Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
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Responsible Party: Barbara Murphy, MD, Sponsor Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04146779    
Other Study ID Numbers: VICC SUPP 18154
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms