Houston, Texas 77030


Purpose:

This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.


Study summary:

PRIMARY OBJECTIVES: I. To determine the feasibility and safety of manual therapy for treatment of fibrosis-related dysphagia in head and neck cancer survivors. SECONDARY OBJECTIVES: I. To examine preliminary efficacy, dose-response (number of treatment sessions to normalized cervical range of motion), and durability of manual therapy for improving cervical range of motion in head and neck cancer survivors with fibrosis-related late dysphagia. II. To examine functional outcomes after manual therapy in head and neck cancer survivors with fibrosis-related late effects and their association with change in dysphagia grade, cervical extension, and other cofactors. OUTLINE: Participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6. After completion of 6 weeks of therapy, participants perform manual therapy at home daily for 6 weeks.


Criteria:

Inclusion Criteria: - Late Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade >= 2 dysphagia on Modified Barium Swallow (MBS) >= 2 years after curative-intent radiotherapy for head and neck cancer - Grade >= 2 Common Terminology Criteria for Adverse Events (CTCAE) fibrosis - Willing and able to return for 10 sessions over 6 weeks of therapy Exclusion Criteria: - Active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment - Active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (MT) regions of interest at time of enrollment - History of subtotal or total glossectomy or total laryngectomy - Functionally limiting cardiac, pulmonary, or neuromuscular disease - Current tracheostomy


NCT ID:

NCT03612531


Primary Contact:

Principal Investigator
Katherine A Hutcheson
M.D. Anderson Cancer Center

Katherine Hutcheson
Phone: 713-792-6920
Email: karnold@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Katherine A. Hutcheson
Phone: 713-792-6920

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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