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

24 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Manual Therapy for swallowing difficulty in head and neck cancer survivors?

Some speech-language pathologists have started using manual therapy techniques to help with swallowing difficulties in head and neck cancer patients, although there is limited information about its effectiveness in this specific group. However, manual therapy is being explored as a way to prevent or rehabilitate swallowing issues in these patients. ^{1 2 3 4 5}

Is manual therapy safe for humans?

Manual therapy, often used for neck pain relief, is generally considered safe for humans, including those who have had head and neck cancer, although specific safety data for swallowing difficulties is limited. ^{1 2 6 7 8}

How is manual therapy different from other treatments for swallowing difficulty in head and neck cancer survivors?

Manual therapy is unique because it involves hands-on techniques by therapists to improve swallowing function, unlike traditional treatments like surgery or radiotherapy that can cause sensory and motor issues. It is a newer approach being explored by some speech-language pathologists to help prevent or rehabilitate swallowing difficulties in these patients. ^{1 2 3 4 9}

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

An occupational therapy program for patients with swallowing dysfunction following cancer treatment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Application of Manual Therapy for Dysphagia in Head and Neck Cancer Patients: A Preliminary National Survey of Treatment Trends and Adverse Events. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of swallowing function in patients with head and neck cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of dysphagia following head and neck cancer. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Dysphagia in head and neck cancer patients treated with radiotherapy and systemic therapies: Literature review and consensus. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Prevention and treatment of dysphagia and aspiration after chemoradiation for head and neck cancer. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Quality of life in patients with dysphagia after radiation and chemotherapy treatment for head and neck tumors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Role of Manual Therapy for Neck Pain and Quality of Life in Head and Neck Cancer Survivors: A Systematic Review. [2022]

9. Singapore pubmed.ncbi.nlm.nih.gov

Radiation-induced swallowing dysfunction in patients with head and neck cancer: A literature review. [2021]