Trial Outcomes & Findings for Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors (NCT NCT03612531)

Results Overview

To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

6 weeks of MT

Results posted on

2026-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Study All patients
Overall Study STARTED	26
Overall Study Completed Intervention Without COVID-19 Interruption	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study All patients
Overall Study COVID-19 interruption	2

Baseline Characteristics

Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=24 Participants All patients
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=20 Participants
Age, Categorical >=65 years	20 Participants n=20 Participants
Sex: Female, Male Female	4 Participants n=20 Participants
Sex: Female, Male Male	20 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants
Race (NIH/OMB) White	23 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Region of Enrollment United States	24 participants n=20 Participants

PRIMARY outcome

Timeframe: 6 weeks of MT

To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.

Outcome measures

Outcome measures
Measure	Overall Study n=24 Participants All patients
Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors	22 Participants

PRIMARY outcome

Timeframe: 6 weeks of MT

To determine safety of Manual Therapy (MT). Participants who did not experience any adverse event while on study.

Outcome measures

Outcome measures
Measure	Overall Study n=24 Participants All patients
Safety of Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors	23 Participants

SECONDARY outcome

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

Will be determined by cervical range of motion (CROM). CROM for each anatomic plane measured by goniometer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 weeks (after manual therapy)

Measured by videofluoroscopy using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and Computational Analysis of Swallowing Mechanics (CASM).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Measured by Therabite ruler.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Measured by the MD Anderson Dysphagia Inventory (MDADI).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Measured by magnetic resonance imaging.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 weeks (after manual therapy)

Electromyography (EMG) scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'

Outcome measures

Outcome data not reported

Adverse Events

Overall Study

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Overall Study n=24 participants at risk All patients
Respiratory, thoracic and mediastinal disorders Dyspnea	4.2% 1/24 • Number of events 1 • baseline to 6 weeks

Additional Information

Katherine Hutcheson, BA,MS,PHD

The University of Texas MD Anderson Cancer Center

Phone: (713) 792-6513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place