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

Primary Purpose

Head and Neck Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Yoga Video

Posture and Strengthening Video

Relaxation Video

Breath Work Video

Satisfaction Survey

Guided Yoga Session

Written Yoga Instructions

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Video and Written Yoga Instruction

Video, Written Yoga Instruction Plus Guided Yoga Sessions

Arm Description

Videos and written instructions on Hatha yoga will be provided

Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided

Outcomes

Primary Outcome Measures

Safety of Hatha yoga

Number of adverse events as graded by CTCAE 4.0

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04146779

First Posted

October 29, 2019

Last Updated

October 6, 2020

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04146779

Brief Title

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

Official Title

Feasibility Study of a Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Terminated

Why Stopped

COVID-19

Study Start Date

October 28, 2019 (Actual)

Primary Completion Date

October 6, 2020 (Actual)

Study Completion Date

October 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Video and Written Yoga Instruction

Arm Type

Experimental

Arm Description

Videos and written instructions on Hatha yoga will be provided

Arm Title

Video, Written Yoga Instruction Plus Guided Yoga Sessions

Arm Type

Experimental

Arm Description

Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided

Intervention Type

Behavioral

Intervention Name(s)

Yoga Video

Intervention Description

A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.

Intervention Type

Behavioral

Intervention Name(s)

Posture and Strengthening Video

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Relaxation Video

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Breath Work Video

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Satisfaction Survey

Intervention Description

Participants will complete a questionnaire addressing satisfaction with the yoga program.

Intervention Type

Behavioral

Intervention Name(s)

Guided Yoga Session

Intervention Description

Instructor guided yoga session twice a week

Intervention Type

Behavioral

Intervention Name(s)

Written Yoga Instructions

Intervention Description

Introduction to Yoga and Yoga poses

Primary Outcome Measure Information:

Title

Safety of Hatha yoga

Description

Number of adverse events as graded by CTCAE 4.0

Time Frame

Approximately 8 weeks

Title

Feasibility of Hatha yoga

Description

Time Frame

Approximately 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Murphy, MD

Organizational Affiliation

Vanderbilt-Ingram Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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