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

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

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Yoga Video; Behavioral: Posture and Strengthening Video; Behavioral: Relaxation Video; Behavioral: Breath Work Video; Behavioral: Satisfaction Survey; Behavioral: Written Yoga Instructions; Behavioral: Guided Yoga Session

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Written Yoga Instructions; Introduction to Yoga and Yoga poses; Behavioral: Guided Yoga Session; Instructor guided yoga session twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): October 6, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: VICC SUPP 18154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No