Your session is about to expire
← Back to Search
Manual Therapy for Swallowing Difficulty in Head and Neck Cancer Survivors (MANTLE Trial)
N/A
Waitlist Available
Led By Katherine A Hutcheson
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)
Awards & highlights
Summary
This trial studies the effectiveness of manual therapy (massage and stretching exercises) in treating fibrosis-related dysphagia (difficulty swallowing) in survivors of head and neck cancer.
Who is the study for?
This trial is for head and neck cancer survivors who have trouble swallowing (dysphagia) due to fibrosis from past treatments. Participants must be able to attend 10 therapy sessions over 6 weeks, have a certain level of fibrosis and swallowing difficulty as assessed by medical criteria, and be at least two years post-radiotherapy. Those with tracheostomies, non-healing wounds in the treatment area, active cancers or extensive surgery history affecting the mouth or throat are excluded.
What is being tested?
The study is testing manual therapy—a form of physical therapy involving massage and stretching exercises—on its effectiveness in improving blood flow, muscle movement, swallowing ability, and range of motion for those suffering from dysphagia caused by fibrosis after head and neck cancer treatment.
What are the potential side effects?
While not explicitly stated here, potential side effects may include discomfort or pain during or after manual therapy sessions. There could also be temporary increased swelling or bruising in treated areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility
Incidence of adverse events
Secondary study objectives
Efficacy and durability of response
Improvement in tongue innervation on Electromyography (EMG) findings
Lingual and jaw range of motion (ROM)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (manual therapy)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Manual Therapy
2018
Completed Phase 3
~1040
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,976 Total Patients Enrolled
18 Trials studying Fibrosis
3,793 Patients Enrolled for Fibrosis
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,677 Total Patients Enrolled
5 Trials studying Fibrosis
475 Patients Enrolled for Fibrosis
Katherine A HutchesonPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
165 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a surgical opening in your neck called a tracheostomy.You have a bone condition called osteoradionecrosis or any other wound that has not healed completely, such as a fistula, ulcer, or soft tissue necrosis, in areas of the body that will be treated with manual therapy during the study.You currently have cancer in your head and neck, central nervous system, or chest that has come back or is a new cancer.You have had surgery to remove part or all of your tongue or voice box.You have a condition that limits the function of your heart, lungs, or muscles.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (manual therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger