Manual Therapy for Swallowing Difficulty in Head and Neck Cancer Survivors
(MANTLE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byKatherine A. Hutcheson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Research Team

Katherine A. Hutcheson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to return for 10 sessions over 6 weeks of therapy

Grade >= 2 Common Terminology Criteria for Adverse Events (CTCAE) fibrosis

Late Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade >= 2 dysphagia on Modified Barium Swallow (MBS) >= 2 years after curative-intent radiotherapy for head and neck cancer

Exclusion 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.

See 2 more

Treatment Details

Interventions

Manual Therapy (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.