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Manual Therapy for Swallowing Difficulty in Head and Neck Cancer Survivors (MANTLE Trial)
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.
- Fibrosis
- Cancer Survivors
- Swallowing Difficulty
- Head and Neck Cancers
MANTLE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MANTLE Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Supportive Care (manual therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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)."
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"
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."
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