Cancer Survivor, Dysphagia, Fibrosis, Head and Neck Carcinoma
Conditions
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.
Detailed description
PRIMARY OBJECTIVES: I. 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.
Interventions
PROCEDUREManual Therapy
Receive manual therapy
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors | 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 | 6 weeks of MT | To determine safety of Manual Therapy (MT). Participants who did not experience any adverse event while on study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and Durability of Response | 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. |
| Swallowing Function and Physiology | 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). |
| Lingual and Jaw Range of Motion (ROM) | Up to 12 weeks | Measured by Therabite ruler. |
| Swallowing-related Quality of Life | Up to 12 weeks | Measured by the MD Anderson Dysphagia Inventory (MDADI). |
| Symptom Burden | Up to 12 weeks | Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN). |
| Lymphedema/Fibrosis Staging | Up to 12 weeks | Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale. |
| Performance Status | Up to 12 weeks | Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN). |
| Soft Tissue Fibrosis | Up to 12 weeks | Measured by magnetic resonance imaging. |
| Improvement in Tongue Innervation on Electromyography (EMG) Findings | 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' |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine A Hutcheson
M.D. Anderson Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 1 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
None listed