Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors
Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors
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.
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 estimate effect size, 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.
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