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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Survivor Dysphagia Fibrosis Head and Neck Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (manual therapy)

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.

Group Type EXPERIMENTAL

Manual Therapy

Intervention Type PROCEDURE

Receive manual therapy

Interventions

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Manual Therapy

Receive manual therapy

Intervention Type PROCEDURE

Other Intervention Names

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MT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No