Clinical trial NCT03612531: Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors
Official title: Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Survivor
Dysphagia
Fibrosis
Head and Neck Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-08-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: Up to 12 weeks
measure: Incidence of adverse events
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Efficacy and durability of response
timeFrame: Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)
measure: Swallowing function and physiology
timeFrame: Baseline to 6 weeks (after manual therapy)
measure: Lingual and jaw range of motion (ROM)
timeFrame: Up to 12 weeks
measure: Swallowing-related quality of life
timeFrame: Up to 12 weeks
measure: Symptom burden
timeFrame: Up to 12 weeks
measure: Lymphedema/fibrosis staging
timeFrame: Up to 12 weeks
measure: Performance status
timeFrame: Up to 12 weeks
measure: Soft tissue fibrosis
timeFrame: Up to 12 weeks
measure: Improvement in tongue innervation on Electromyography (EMG) findings
timeFrame: Baseline to 6 weeks (after manual therapy)
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Katherine A Hutcheson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.