M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT03612531
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive manual therapy
Other names: MT
Time frame: 6 weeks of MT
To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.
Time frame: 6 weeks of MT
To determine safety of Manual Therapy (MT). Participants who did not experience any adverse event while on study.
Time frame: Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)
Will be determined by cervical range of motion (CROM). CROM for each anatomic plane measured by goniometer.
Time frame: Baseline to 6 weeks (after manual therapy)
Measured by videofluoroscopy using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and Computational Analysis of Swallowing Mechanics (CASM).
Time frame: Up to 12 weeks
Measured by Therabite ruler.
Time frame: Up to 12 weeks
Measured by the MD Anderson Dysphagia Inventory (MDADI).
Time frame: Up to 12 weeks
Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN).
Time frame: Up to 12 weeks
Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale.
Time frame: Up to 12 weeks
Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN).
Time frame: Up to 12 weeks
Measured by magnetic resonance imaging.
Time frame: Baseline to 6 weeks (after manual therapy)
Electromyography (EMG) scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'
M.D. Anderson Cancer Center
Other
Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE Trial
Acronym: MANTLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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