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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

MANTLE Trial 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.

Eligible Conditions
  • Fibrosis
  • Cancer Survivors
  • Swallowing Difficulty
  • Head and Neck Cancers

MANTLE Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility
Incidence of adverse events
Secondary outcome measures
Efficacy and durability of response
Improvement in tongue innervation on Electromyography (EMG) findings
Lingual and jaw range of motion (ROM)
+6 more

MANTLE 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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,622 Total Patients Enrolled
18 Trials studying Fibrosis
3,816 Patients Enrolled for Fibrosis
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,425 Total Patients Enrolled
4 Trials studying Fibrosis
180 Patients Enrolled for Fibrosis
Katherine A HutchesonPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
145 Total Patients Enrolled

Media Library

Manual Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03612531 — N/A
Fibrosis Research Study Groups: Supportive Care (manual therapy)
Fibrosis Clinical Trial 2023: Manual Therapy Highlights & Side Effects. Trial Name: NCT03612531 — N/A
Manual Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03612531 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the objective of this medical experiment?

"The primary evaluation metric of this trial, observed over a period of up to 12 weeks, is the incidences of adverse effects. Secondary outcomes include improvement in tongue innervation as determined by Electromyography (EMG) scores on a 4-point scale; Lymphedema/fibrosis staging through Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale.; Performance status via the Performance Status Scale for Head and neck cancer Patients (PSS-HN)."

Answered by AI

What is the overall participant count for this clinical investigation?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is actively recruiting participants, with 24 patients being sought from one centre of care since its inception on August 6th 2018 and last update occurring September 22nd 2022"

Answered by AI

Is recruitment for this experiment still ongoing?

"As indicated in the clinicaltrials.gov page, this study is actively enlisting patients. The experiment was initially posted on August 6th 2018 and its details were last updated on September 22nd 2022."

Answered by AI
~4 spots leftby Mar 2025