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

Not Applicable

Terminated

• Conditions: Head and Neck Cancer

• 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

Primary Outcome Measures

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

Trial Locations

Locations (1)

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