Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/4/2018 |
Start Date: | July 1, 2018 |
End Date: | July 31, 2020 |
Contact: | Katherine Hutcheson |
Email: | karnold@mdanderson.org |
Phone: | 713-792-6920 |
Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE Trial
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.
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.
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 examine preliminary efficacy, 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.
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 examine preliminary efficacy, 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.
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) at time of enrollment
- History of subtotal or total glossectomy or total laryngectomy
- Functionally limiting cardiac, pulmonary, or neuromuscular disease
- Current tracheostomy
We found this trial at
1
site
Click here to add this to my saved trials