Cancer SurvivorMANTLENCT03612531
Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors
A study testing Manual Therapy in people with Cancer Survivor and Dysphagia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Dysphagia, Fibrosis
- What is being tested?
- Manual Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Grade >= 2 Common Terminology Criteria for Adverse Events (CTCAE) fibrosis
- Willing and able to return for 10 sessions over 6 weeks of therapy
Who cannot join
- Active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment
- Active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (MT) regions of interest at time of enrollment
- History of subtotal or total glossectomy or total laryngectomy
- Functionally limiting cardiac, pulmonary, or neuromuscular disease
- Current tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility and safety of manual therapy for treatment of fibrosis-related dysphagia in head and neck cancer survivors.
SECONDARY OBJECTIVES:
I.To estimate effect size, dose-response (number of treatment sessions to normalized cervical range of motion), and durability of manual therapy for improving cervical range of motion in head and neck cancer survivors with fibrosis-related late dysphagia.
II. To examine functional outcomes after manual therapy in head and neck cancer survivors with fibrosis-related late effects and their association with change in dysphagia grade, cervical extension, and other cofactors.
OUTLINE:
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.
- Conditions
- Cancer Survivor, Dysphagia, Fibrosis, Head and Neck Carcinoma
- Being tested
- Manual Therapy
- Medical subject headings
- Deglutition Disorders, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyProcedure or surgery
Also called MT
Receive manual therapy
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (manual therapy) | Experimental | 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. Receives: Procedure: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors
To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.
Measured: 6 weeks of MT
Safety of Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors
To determine safety of Manual Therapy (MT). Participants who did not experience any adverse event while on study.
Measured: 6 weeks of MT
Secondary outcomes (9)
Efficacy and Durability of Response
Will be determined by cervical range of motion (CROM). CROM for each anatomic plane measured by goniometer.
Measured: Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)
Swallowing Function and Physiology
Measured by videofluoroscopy using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and Computational Analysis of Swallowing Mechanics (CASM).
Measured: Baseline to 6 weeks (after manual therapy)
Lingual and Jaw Range of Motion (ROM)
Measured by Therabite ruler.
Measured: Up to 12 weeks
Swallowing-related Quality of Life
Measured by the MD Anderson Dysphagia Inventory (MDADI).
Measured: Up to 12 weeks
Symptom Burden
Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN).
Measured: Up to 12 weeks
Lymphedema/Fibrosis Staging
Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale.
Measured: Up to 12 weeks
Performance Status
Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN).
Measured: Up to 12 weeks
Soft Tissue Fibrosis
Measured by magnetic resonance imaging.
Measured: Up to 12 weeks
Improvement in Tongue Innervation on Electromyography (EMG) Findings
Electromyography (EMG) scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'
Measured: Baseline to 6 weeks (after manual therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start6 Aug 2018
- Primary completion15 Jul 2022
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katherine A Hutcheson, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612531
- Sponsor's protocol ID
- 2018-0052
- Other IDs
- NCI-2018-01511, 2018-0052, R21CA226200
- Acronym
- MANTLE
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2018
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McMillan H, Okoro C, Buoy S, Woodman K, Anderson N, Fuller C, Lai SY, Hutcheson K. Hypoglossal Neuropathy in the Pathogenesis of Fibrosis-Related Late-Radiation Associated Dysphagia: A Correlative Analysis Utilizing Electromyography to Explore the Frequency of Clinical and Subclinical Neuropathy in a Pilot Dysphagia Trial. Head Neck. 2026 Feb;48(2):438-448. doi: 10.1002/hed.70024. Epub 2025 Sep 10.
PubMed 40927950McMillan H, Warneke CL, Buoy S, Porsche C, Savage K, Lai SY, Fuller CD, Hutcheson KA. Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The MANTLE Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Apr 1;151(4):319-327. doi: 10.1001/jamaoto.2024.5157.
PubMed 39913160Hutcheson K, McMillan H, Warneke C, Porsche C, Savage K, Buoy S, Wang J, Woodman K, Lai S, Fuller C. Manual Therapy for Fibrosis-Related Late Effect Dysphagia in head and neck cancer survivors: the pilot MANTLE trial. BMJ Open. 2021 Aug 4;11(8):e047830. doi: 10.1136/bmjopen-2020-047830.
PubMed 34348950
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE Trial
- ClinicalTrials.gov ID
- NCT03612531
- Acronym / sponsor ID
- MANTLE / 2018-0052
- Conditions
- Cancer Survivor, Dysphagia, Fibrosis, Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility and safety of manual therapy for treatment of fibrosis-related dysphagia in head and neck cancer survivors.
SECONDARY OBJECTIVES:
I.To estimate effect size, dose-response (number of treatment sessions to normalized cervical range of motion), and durability of manual therapy for improving cervical range of motion in head and neck cancer survivors with fibrosis-related late dysphagia.
II. To examine functional outcomes after manual therapy in head and neck cancer survivors with fibrosis-related late effects and their association with change in dysphagia grade, cervical extension, and other cofactors.
OUTLINE:
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (manual therapy) | Experimental | Procedure: Manual TherapyParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- Grade >= 2 Common Terminology Criteria for Adverse Events (CTCAE) fibrosis
- Willing and able to return for 10 sessions over 6 weeks of therapy
Key exclusion criteria (5 listed)
- Active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment
- Active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (MT) regions of interest at time of enrollment
- History of subtotal or total glossectomy or total laryngectomy
- Functionally limiting cardiac, pulmonary, or neuromuscular disease
- Current tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TherapyAlso: MTReceive manual therapy | Procedure or surgery | Supportive Care (manual therapy) |
Primary outcome
Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors
Time frame: 6 weeks of MT
To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.
Safety of Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors
Time frame: 6 weeks of MT
To determine safety of Manual Therapy (MT). Participants who did not experience any adverse event while on study.
9 secondary outcomes
Efficacy and Durability of Response
Time frame: Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)
Swallowing Function and Physiology
Time frame: Baseline to 6 weeks (after manual therapy)
Lingual and Jaw Range of Motion (ROM)
Time frame: Up to 12 weeks
Swallowing-related Quality of Life
Time frame: Up to 12 weeks
Symptom Burden
Time frame: Up to 12 weeks
Lymphedema/Fibrosis Staging
Time frame: Up to 12 weeks
Performance Status
Time frame: Up to 12 weeks
Soft Tissue Fibrosis
Time frame: Up to 12 weeks
Improvement in Tongue Innervation on Electromyography (EMG) Findings
Time frame: Baseline to 6 weeks (after manual therapy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40927950McMillan H, Okoro C, Buoy S, Woodman K, Anderson N, Fuller C, Lai SY, Hutcheson K. Hypoglossal Neuropathy in the Pathogenesis of Fibrosis-Related Late-Radiation Associated Dysphagia: A Correlative Analysis Utilizing Electromyography to Explore the Frequency of Clinical and Subclinical Neuropathy in a Pilot Dysphagia Trial. Head Neck. 2026 Feb;48(2):438-448. doi: 10.1002/hed.70024. Epub 2025 Sep 10.
- Derived from this study: PubMed 39913160McMillan H, Warneke CL, Buoy S, Porsche C, Savage K, Lai SY, Fuller CD, Hutcheson KA. Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The MANTLE Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Apr 1;151(4):319-327. doi: 10.1001/jamaoto.2024.5157.
- Derived from this study: PubMed 34348950Hutcheson K, McMillan H, Warneke C, Porsche C, Savage K, Buoy S, Wang J, Woodman K, Lai S, Fuller C. Manual Therapy for Fibrosis-Related Late Effect Dysphagia in head and neck cancer survivors: the pilot MANTLE trial. BMJ Open. 2021 Aug 4;11(8):e047830. doi: 10.1136/bmjopen-2020-047830.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Hutcheson principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy in people with Cancer Survivor and Dysphagia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors (time frame: 6 weeks of MT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612531, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.