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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

No Placebo-Only Group

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks) for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

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