NCT03612531

Brief 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 ability and range of motion in participants who have had treatment for head and neck cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
33mo left

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Aug 2018Dec 2028

First Submitted

Initial submission to the registry

July 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

10.4 years

First QC Date

July 26, 2018

Last Update Submit

April 20, 2026

Conditions

Cancer SurvivorDysphagiaFibrosisHead and Neck Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Feasibility

    Will be determined by completion rate. Completion rate will be defined by completion of the 6 week clinical manual therapy (MT) program without withdrawing and attending a minimum of 2 sessions and the post-treatment assessment. Session attendance will be monitored separately to assess adherence and fidelity. Will summarize fidelity and adherence to the standard MT protocol using quantitative and qualitative methods.

    Up to 12 weeks

  • Incidence of adverse events

    Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events will be tabulated and will be monitored by the trial Data Safety Monitoring Board.

    Up to 12 weeks

Secondary Outcomes (9)

  • Efficacy and durability of response

    Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)

  • Swallowing function and physiology

    Baseline to 6 weeks (after manual therapy)

  • Lingual and jaw range of motion (ROM)

    Up to 12 weeks

  • Swallowing-related quality of life

    Up to 12 weeks

  • Symptom burden

    Up to 12 weeks

  • +4 more secondary outcomes

Study Arms (1)

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.

Procedure: Manual Therapy

Interventions

Manual TherapyPROCEDURE

Receive manual therapy

Also known as: MT
Supportive Care (manual therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • McMillan 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.

    PMID: 39913160DERIVED

  • Hutcheson 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.

    PMID: 34348950DERIVED

Related Links

MeSH Terms

Conditions

Deglutition DisordersFibrosis

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Katherine A Hutcheson

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 2, 2018

Study Start

August 6, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(1)