Manual Therapy for Swallowing Difficulty in Head and Neck Cancer Survivors

(MANTLE Trial)

Overseen By Katherine Hutcheson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active cancer, Non-healing wounds, Glossectomy, Laryngectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether manual therapy, including massage and stretching exercises, can aid those who struggle with swallowing after head and neck cancer treatment. The focus is on enhancing swallowing and movement in the neck and mouth by boosting blood flow and muscle flexibility. Individuals who have experienced swallowing difficulties and completed cancer treatment at least two years ago may be suitable candidates. Participants will attend therapy sessions and continue exercises at home to assess improvements in swallowing. As an unphased trial, this study provides a unique opportunity for patients to explore new therapeutic options that may enhance their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that manual therapy is safe for treating swallowing difficulties in head and neck cancer survivors?

Research has shown that manual therapy, including massage and stretching exercises, is generally safe and well-tolerated by individuals experiencing swallowing difficulties after head and neck cancer treatment. Studies have found that speech-language pathologists frequently use this therapy during and after cancer treatment. Reported side effects resemble those in other physical therapies, usually involving mild discomfort or soreness. However, these side effects are uncommon and typically not severe. Overall, manual therapy is considered safe for helping these patients improve their swallowing ability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for swallowing difficulties in head and neck cancer survivors focus on dietary changes and swallowing exercises. However, manual therapy is unique because it involves hands-on techniques performed by a speech pathologist to improve muscle function and mobility in the throat. This approach offers a more direct and potentially faster way to enhance swallowing ability. Researchers are excited about manual therapy because it empowers patients to continue the treatment at home, promoting long-term improvement and self-management.

What evidence suggests that manual therapy is effective for treating swallowing difficulty in head and neck cancer survivors?

Research has shown that manual therapy, including massage and stretching exercises, may aid individuals with swallowing difficulties after head and neck cancer. These exercises can increase blood flow and enhance muscle movement in the neck and throat. This trial will evaluate the effectiveness of manual therapy, with participants receiving 10 sessions from a speech pathologist over six weeks, followed by daily home exercises for another six weeks. Reports indicate that this method enhances swallowing ability and movement. Specifically, manual therapy can assist in opening the mouth and improving swallowing function. These findings suggest that manual therapy might effectively manage swallowing problems related to tissue stiffness after cancer treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Katherine A. Hutcheson

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6

6 weeks

10 visits (in-person)

Home Therapy

Participants perform manual therapy at home daily

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Manual Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Supportive Care (manual therapy) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11189010/

A Survey of Manual Therapy Techniques and Protocols ... This study aimed to better understand MT protocols employed by SLPs to prevent and treat dysphagia in HNC patients during and after Radiation Therapy (RT).

2. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e097131

Effects of manual therapy on oral opening ... Manual Therapy for Fibrosis-Related Late Effect Dysphagia in head and neck cancer survivors: the pilot MANTLE trial. ... Improving swallowing outcomes in patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6482656/

Application of Manual Therapy for Dysphagia in Head and ... This preliminary survey demonstrated that SLPs provide MT to HNC patients during and after cancer treatment, and that reported adverse events paralleled those ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/9/e097131.full.pdf

Effects of manual therapy on oral Intervention will last for 6 weeks with a total of 18 sessions, including MT targeting mastication and head and neck muscles. The control group ...

5. researchgate.net researchgate.net/publication/395205310_Effects_of_manual_therapy_on_oral_opening_swallow_function_and_upper_quarter_mobility_in_Chilean_survivors_of_head_and_neck_cancer_a_study_protocol_for_a_controlled_randomised_study_MAnual_ThErapy_for

(PDF) Effects of manual therapy on oral opening, swallow ... This study protocol aims to investigate the effects of manual therapy (MT) to determine the effectiveness and safety on oral opening, swallow ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/2164956119844151

Application of Manual Therapy for Dysphagia in Head and ... Application of Manual Therapy for Dysphagia in Head and Neck Cancer Patients: A Preliminary National Survey of Treatment Trends and Adverse ...