Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal CarcinomaNCT05512767
A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation
A study testing Best Practice, Consensus Auditory-Perceptual Evaluation of Voice and Diagnostic Imaging in people with Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma and Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, run by Mayo Clinic.
Trial summary
This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal Carcinoma
- What is being tested?
- Best Practice, Consensus Auditory-Perceptual Evaluation of Voice and Diagnostic Imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 22 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent
- Cognitive function adequate to understand and execute the elements of the protocol
- Willingness and ability to return to Mayo Clinic for follow-up care per protocol
- Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)
- Must demonstrate oropharyngeal competency that would allow some oral intake
Who cannot join
- Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer
- Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative
- Acute facial infection
- Active congestive heart failure (CHF) or pulmonary edema
- Symptomatic carotid artery disease or bradycardia
- Increased intracranial pressure
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- History of multiple cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs)
- > 50% internal carotid artery (ICA) blockage
- Upper quadrant deep vein thrombosis
- Known esophageal obstruction
- Percutaneous endoscopic gastrostomy (PEG) tube dependence with no oral intake
- Women of child-bearing potential
- (Active) pregnancy
About this study
Official title: Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population
This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Lymphedema can be the result of surgery, radiation therapy, chemotherapy or any combination of these procedures. Internal lymphedema has been shown to negatively affect speech production, swallowing, respiration, and voice. Flexitouch is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides pressure changes to move lymph fluid from the impaired area toward healthy regions of the body. Complete decongestive therapy (CDT) is standard of care for treating external lymphedema and involves manual lymphatic drainage (MLD) performed by licensed therapists followed by compression therapy. CDT has long been used for treating lymphedema of the limbs. Combining a pneumatic compression system with standard of care manual lymphatic drainage may have positive effects on speech, voice, and swallowing.
Read the detailed description
PRIMARY OBJECTIVES:
- Compare success rates in reducing internal and external lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). Assess efficacy of PCD and MLD.
II. Assess compliance of treatment in both groups. III. Assess changes in voice and swallowing in both groups.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.
GROUP II: Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.
- Conditions
- Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal Carcinoma, Head and Neck Carcinoma, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8
- Being tested
- Best Practice, Consensus Auditory-Perceptual Evaluation of Voice, Diagnostic Imaging, Lymphedema Management, Modified Barium Swallow
- Medical subject headings
- Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo self-manual lymphatic drainage
Consensus Auditory-Perceptual Evaluation of VoiceOther
Also called CAPE-V, Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Ancillary studies
Diagnostic ImagingProcedure or surgery
Also called Medical Imaging
Undergo photographs of face and neck
Lymphedema ManagementOther
Undergo skilled lymphedema treatment by a therapist
Modified Barium SwallowProcedure or surgery
Also called MBS, VFSS, Videofluoroscopic Swallowing Study
Undergo swallow study
Nasopharyngeal LaryngoscopyProcedure or surgery
Undergo Nasolaryngoscopy
Pneumatic Compression TherapyDevice
Also called Flexi-touch Plus System
Undergo compression therapy - Flexitouch Plus System is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides systematic and sequential pressure changes to move fluid to intact lymphatic chains.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Voice Handicap Index-10Other
Also called VHI-10, Voice Handicap Index-10 (VHI-10)
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (pneumatic therapy, lymphedema management) | Experimental | Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline. Receives: Other: Consensus Auditory-Perceptual Evaluation of Voice; Procedure: Diagnostic Imaging; Other: Lymphedema Management; Procedure: Modified Barium Swallow; Procedure: Nasopharyngeal Laryngoscopy; Device: Pneumatic Compression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Voice Handicap Index-10 |
| Group II (standard of care, lymphedema management) | Active comparator | Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline. Receives: Other: Best Practice; Other: Consensus Auditory-Perceptual Evaluation of Voice; Procedure: Diagnostic Imaging; Other: Lymphedema Management; Procedure: Modified Barium Swallow; Procedure: Nasopharyngeal Laryngoscopy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Voice Handicap Index-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare composite measurements of the face and neck for lymphatic drainage
Will be completed at baseline and at the conclusion of the study to assess and compare the effects of traditional manual lymphatic drainage to those from use of a pneumatic compression system.
Measured: Change from baseline and up to 12 weeks
Change in lymphedema of the head and neck
A reduction in one grade on the Mayo Clinic Lymphedema - head and neck (HN) Grading Scale (MCLGS) or one stage on the MD Anderson Cancer Center (MDACC) grading system for lymphedema of the head and neck.
Measured: Up to 12 weeks
Secondary outcomes (3)
Improvements on quality of life (QOL) function
Measured by QOL questionnaire and Facial and Neck Composite Measurements
Status Scale:
PSS-HN
Measured: Up to 12 weeks
Improvements on voice function
Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V
Measured: Up to 12 weeks
Improvements on swallowing function
Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Dec 2022 (estimated)
- Primary completion22 Aug 2023 (estimated)
- Study completion22 Aug 2024 (estimated)
Why it stopped: PI retired and study not moving forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Crujido, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512767
- Sponsor's protocol ID
- 21-003342
- Other IDs
- NCI-2022-06767
- Status last verified
- Jan 2023
- First submitted
- 17 Aug 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population
- ClinicalTrials.gov ID
- NCT05512767
- Acronym / sponsor ID
- 21-003342
- Conditions
- Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal Carcinoma, Head and Neck Carcinoma, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI retired and study not moving forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 22 Aug 2023 (estimated)
- Study completion
- 22 Aug 2024 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Lymphedema can be the result of surgery, radiation therapy, chemotherapy or any combination of these procedures. Internal lymphedema has been shown to negatively affect speech production, swallowing, respiration, and voice. Flexitouch is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides pressure changes to move lymph fluid from the impaired area toward healthy regions of the body. Complete decongestive therapy (CDT) is standard of care for treating external lymphedema and involves manual lymphatic drainage (MLD) performed by licensed therapists followed by compression therapy. CDT has long been used for treating lymphedema of the limbs. Combining a pneumatic compression system with standard of care manual lymphatic drainage may have positive effects on speech, voice, and swallowing.
Detailed description
PRIMARY OBJECTIVES:
- Compare success rates in reducing internal and external lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). Assess efficacy of PCD and MLD.
II. Assess compliance of treatment in both groups. III. Assess changes in voice and swallowing in both groups.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.
GROUP II: Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (pneumatic therapy, lymphedema management) | Experimental | Other: Consensus Auditory-Perceptual Evaluation of Voice, Procedure: Diagnostic Imaging, Other: Lymphedema Management, Procedure: Modified Barium Swallow, Procedure: Nasopharyngeal Laryngoscopy, Device: Pneumatic Compression Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Voice Handicap Index-10Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline. |
| Group II (standard of care, lymphedema management) | Active comparator | Other: Best Practice, Other: Consensus Auditory-Perceptual Evaluation of Voice, Procedure: Diagnostic Imaging, Other: Lymphedema Management, Procedure: Modified Barium Swallow, Procedure: Nasopharyngeal Laryngoscopy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Voice Handicap Index-10Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent
- Cognitive function adequate to understand and execute the elements of the protocol
- Willingness and ability to return to Mayo Clinic for follow-up care per protocol
- Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)
- Must demonstrate oropharyngeal competency that would allow some oral intake
Key exclusion criteria (13 listed)
- Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer
- Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative
- Acute facial infection
- Active congestive heart failure (CHF) or pulmonary edema
- Symptomatic carotid artery disease or bradycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo self-manual lymphatic drainage | Other | Group II (standard of care, lymphedema management) |
| Consensus Auditory-Perceptual Evaluation of VoiceAlso: CAPE-V, Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)Ancillary studies | Other | Group I (pneumatic therapy, lymphedema management), Group II (standard of care, lymphedema management) |
| Diagnostic ImagingAlso: Medical ImagingUndergo photographs of face and neck | Procedure or surgery | Group I (pneumatic therapy, lymphedema management), Group II (standard of care, lymphedema management) |
| Lymphedema ManagementUndergo skilled lymphedema treatment by a therapist | Other | Group I (pneumatic therapy, lymphedema management), Group II (standard of care, lymphedema management) |
| Modified Barium SwallowAlso: MBS, VFSS, Videofluoroscopic Swallowing StudyUndergo swallow study | Procedure or surgery | Group I (pneumatic therapy, lymphedema management), Group II (standard of care, lymphedema management) |
| Nasopharyngeal LaryngoscopyUndergo Nasolaryngoscopy | Procedure or surgery | Group I (pneumatic therapy, lymphedema management), Group II (standard of care, lymphedema management) |
| Pneumatic Compression TherapyAlso: Flexi-touch Plus SystemUndergo compression therapy - Flexitouch Plus System is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides systematic and sequential pressure changes to move fluid to intact lymphatic chains. | Device | Group I (pneumatic therapy, lymphedema management) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (pneumatic therapy, lymphedema management), Group II (standard of care, lymphedema management) |
| Questionnaire AdministrationAncillary studies | Other | Group I (pneumatic therapy, lymphedema management), Group II (standard of care, lymphedema management) |
| Voice Handicap Index-10Also: VHI-10, Voice Handicap Index-10 (VHI-10)Ancillary studies | Other | Group I (pneumatic therapy, lymphedema management), Group II (standard of care, lymphedema management) |
Primary outcome
Compare composite measurements of the face and neck for lymphatic drainage
Time frame: Change from baseline and up to 12 weeks
Will be completed at baseline and at the conclusion of the study to assess and compare the effects of traditional manual lymphatic drainage to those from use of a pneumatic compression system.
Change in lymphedema of the head and neck
Time frame: Up to 12 weeks
A reduction in one grade on the Mayo Clinic Lymphedema - head and neck (HN) Grading Scale (MCLGS) or one stage on the MD Anderson Cancer Center (MDACC) grading system for lymphedema of the head and neck.
3 secondary outcomes
Improvements on quality of life (QOL) function
Time frame: Up to 12 weeks
Improvements on voice function
Time frame: Up to 12 weeks
Improvements on swallowing function
Time frame: Up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Crujido principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Consensus Auditory-Perceptual Evaluation of Voice and Diagnostic Imaging in people with Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma and Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare composite measurements of the face and neck for lymphatic drainage (time frame: Change from baseline and up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.