Clinical trial NCT01951664: Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors
Official title: Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Neck Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2013-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Treatment for head and neck cancer can result in marked musculo-skeletal impairment (MSI). This study will examine the effects of Hatha Yoga as a therapeutic modality to address MSI.

Detailed description: The use of aggressive treatment for head and neck cancer (HNC) particularly combined modality treatment regimens has resulted in an increase in survival. Unfortunately, this improvement has come with a marked increase in acute and late-effects. Acute HNC treatment-related toxicities have been clearly and extensively documented; however, data pertaining to adverse late-effects, those most likely to impact the survivor's long term symptom burden, functionality, and overall quality of life (QOL), are limited. This pilot study will be conducted to examine the feasibility of tailored Hatha Yoga as a therapeutic modality to address MSI in patients who have survived HNC.

Eligibility criteria: Inclusion Criteria:

* \>/= 18 years of age
* \>3 months post-treatment of HNC
* no active cancer
* ability to understand English in order to complete questionnaires
* willing to participate in the guided and home Yoga practice
* willing to drive to the study site
* willing and able to provide informed consent
* completed medically indicated physical therapy
* medical clearance by study medical oncologist

Exclusion Criteria:

* a prior cancer diagnosis within the past three years (except basal cell, surgically treated squamous cell skin cancer, early prostate cancer under observation)
* have received radiation therapy or chemotherapy for any condition other than primary HNC
* medical conditions that would prohibit the safe implementation of a Yoga practice (e.g., vertigo, dementia)
* active Yoga practice within the past 6 months

Primary outcomes:
measure: Number of patients who complete a modified Yoga program for HNC survivors
timeFrame: at 8 weeks
Secondary outcomes:
measure: Change in range of motion (ROM) jaw maximal inter-incisoral opening
timeFrame: at 8 weeks
measure: Change in cervical ROM
timeFrame: at 8 weeks
measure: Change in head and neck-related treatment systems
timeFrame: at 8 weeks
measure: Change in Brief Pain Inventory
timeFrame: at 8 weeks
measure: Change in Body Image Quality of Life Inventory
timeFrame: at 8 weeks
measure: Change in Anxiety and Depression Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University School of Nursing
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Nursing
name: Sheila H Ridner, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: