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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04146779
• Other study ID #: VICC SUPP 18154
• Status: Terminated
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: October 6, 2020

Study information

• Verified date: October 2020
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Behavioral:
• Yoga Video
A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.
• 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.
• Relaxation Video
The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes
• Breath Work Video
The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.
• Satisfaction Survey
Participants will complete a questionnaire addressing satisfaction with the yoga program.
• Guided Yoga Session
Instructor guided yoga session twice a week
• Written Yoga Instructions
Introduction to Yoga and Yoga poses

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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