- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01649583
Feasibility Study of Dynasplint to Prevent Trismus in Head and Neck Cancer
A Feasibility Study to Evaluate Use of the Jaw Dynasplint System to Prevent Trismus in Patients With Head and Neck Cancer Receiving Primary or Adjuvant Radiation-Based Therapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Data suggest that early intervention with mechanical stretching devices for head and neck cancer patients undergoing curative therapy maximizes their effectiveness in the treatment of trismus. That being said, treatment for trismus typically begins after head and neck cancer patients are found to have moderate to severe reduction in jaw range of motion. Typically, clinicians will begin therapy when the IID is 3.0 cm or less. A subset of head and neck cancer patients will develop severe or rapidly progressive trismus that will fail to respond to treatment. In this cohort, trismus may lead to permanent, severe morbidity. It may be hypothesized that preventative strategies that encourage routine stretching during and immediately after the completion of cancer therapy may prevent or minimize trismus. No studies have examined the prophylactic use of the Jaw Dynasplint® System during cancer treatment.
Furthermore, it is not known whether patients can tolerate wearing a mechanical stretching device during treatment. The investigators would like to test the hypothesis that: 1) preventive use of a mechanical stretching device during cancer treatment and early recovery is feasible, and 2) preventive use of a mechanical stretching device will result in a marked decrease in the incidence and severity of trismus in patients undergoing primary or adjuvant radiation therapy for head and neck cancer.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with histologically proven head and neck cancer
- Planned primary or adjuvant radiation treatment with 50cGy or greater delivered to a total volume of at least 2cc to the muscles of mastication, unilaterally or bilaterally, over the entire course of radiation treatment
- Patients receiving induction or concurrent chemotherapy
- Baseline interincisoral distance > 35 mm
- Willing and able to provide informed consent
- Sufficient manual dexterity to utilize the device
- All participants must be at least 21 years of age
Exclusion Criteria:
- Patients with collagen vascular disorders that may predispose to radiation fibrosis
- Patients with oral health issues that would preclude use of the device as identified during a pre-radiation dental evaluation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Kontrolarm
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Eksperimentel: Jaw Dynasplint System
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Patients on the intervention arm will wear the Jaw Dynasplint® System for 30 minutes, 3 times per day each day during the cancer treatment period and for the first 3 months after primary or adjuvant based-radiation treatment (recovery period) is completed.
Patients will maintain a daily patient log indicating the amount of time they used the Jaw Dynasplint® System.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients
Tidsramme: 2 years
|
Feasibility will be measured based on patient compliance, adverse events, and barriers to use of the Jaw Dynasplint® System.
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Preliminary Efficacy Data on Prevention of Trismus
Tidsramme: 2 years
|
Interincisoral distance (IID) will be the primary measure of efficacy.
Any patient who develops IID of 30 mm or less will be considered to have clinically significant trismus.
The incidence of trismus will be compared between the intervention arm (Arm 1) and the standard of care arm (Arm 2).
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2 years
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Symptom Burden of Patients with Trismus
Tidsramme: 2 years
|
Patient reported outcome data will be collected via questionnaires including, the Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey version 2.0 (VHNSS v2.0 plus GSS), and the Mandibular Function Impairment Questionnaire (MFIQ).
This patient reported outcome data will be collected in order to identify correlations between trismus and symptom burden.
|
2 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Lauren A Zatarain, MD, Vanderbilt University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 120727
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Jaw Dynasplint System
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University of Alabama at BirminghamDynasplint Systems, Inc.Afsluttet
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University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalUkendt
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Dynasplint Systems, Inc.Afsluttet
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Universidade Norte do ParanáHopital du Sacre-Coeur de MontrealAfsluttetErhvervet fast fleksionsdeformitet i knæet (lidelse)Canada
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United States Naval Medical Center, San DiegoAfsluttet
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University of AlbertaCross Cancer InstituteAfsluttetTrismus | Neoplasmer, hoved og halsCanada
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Dynasplint Systems, Inc.AfsluttetHallux LimitusForenede Stater
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Dynasplint Systems, Inc.Afsluttet