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

Not Applicable

Terminated

• Conditions: Head and Neck Cancer
• Interventions: 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

• Registration Number: NCT04146779
• Lead Sponsor: 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

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 Timeline

• Study Start: 2019-10-28
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Status Verified: 2020-10
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-06
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video and Written Yoga Instruction	Breath Work Video	Videos and written instructions on Hatha yoga will be provided
Video and Written Yoga Instruction	Relaxation Video	Videos and written instructions on Hatha yoga will be provided
Video, Written Yoga Instruction Plus Guided Yoga Sessions	Yoga Video	Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided
Video, Written Yoga Instruction Plus Guided Yoga Sessions	Breath Work Video	Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided
Video and Written Yoga Instruction	Yoga Video	Videos and written instructions on Hatha yoga will be provided
Video and Written Yoga Instruction	Posture and Strengthening Video	Videos and written instructions on Hatha yoga will be provided
Video and Written Yoga Instruction	Satisfaction Survey	Videos and written instructions on Hatha yoga will be provided
Video, Written Yoga Instruction Plus Guided Yoga Sessions	Relaxation Video	Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided
Video, Written Yoga Instruction Plus Guided Yoga Sessions	Satisfaction Survey	Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided
Video, Written Yoga Instruction Plus Guided Yoga Sessions	Guided Yoga Session	Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided
Video, Written Yoga Instruction Plus Guided Yoga Sessions	Written Yoga Instructions	Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided
Video and Written Yoga Instruction	Written Yoga Instructions	Videos and written instructions on Hatha yoga will be provided
Video, Written Yoga Instruction Plus Guided Yoga Sessions	Posture and Strengthening Video	Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided

Primary Outcome Measures

Name	Time	Method
Safety of Hatha yoga	Approximately 8 weeks	Number of adverse events as graded by CTCAE 4.0
Feasibility of Hatha yoga	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)

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States