Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531083
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of PRospective Surveillance and Early PhysiCal Therapy for TrIsmuS in Individuals with Head and Neck CancEr a Pilot Randomized Trial PRECISE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECISE
Brief Summary:
Trismus or restricted jaw movement can occur in individuals with head and neck cancer HNC undergoing surgery or radiation therapy There is a paucity of research examining interventions for trismus We aim to assess the feasibility of prospective surveillance and early intervention to mitigate trismus in individuals undergoing HNC treatment
Method The investigators will conduct a pilot randomized feasibility trial involving 30 individuals with HNC who will be undergoing radiation therapy Participants will be identified at the HNC new patient clinic Those consenting will be randomized to either usual care UC or to prospective surveillance PS UC participants will receive active exercises and referral to physical therapy if trismus is detected Participants in the PS group will receive early intervention including manual therapy and a device-based jaw exercise regimen if presenting with 5 or greater reduction in jaw opening compared to pre-treatment
The investigators will assess recruitment and completion rates intervention acceptability and data collection procedures Descriptive statistics will summarize feasibility metrics and participant demographics Findings will inform the design of a larger multicentre trial
Method The investigators will conduct a pilot randomized feasibility trial involving 30 individuals with HNC who will be undergoing radiation therapy Participants will be identified at the HNC new patient clinic Those consenting will be randomized to either usual care UC or to prospective surveillance PS UC participants will receive active exercises and referral to physical therapy if trismus is detected Participants in the PS group will receive early intervention including manual therapy and a device-based jaw exercise regimen if presenting with 5 or greater reduction in jaw opening compared to pre-treatment
The investigators will assess recruitment and completion rates intervention acceptability and data collection procedures Descriptive statistics will summarize feasibility metrics and participant demographics Findings will inform the design of a larger multicentre trial
Detailed Description:
1 Background and rationale Head and neck cancers HNCs originate in the nasal cavity sinuses lips mouth salivary glands throat and larynx Individuals undergoing treatment for HNC often develop side effects such as oral mucositis xerostomia and experience difficulties with swallowing and speech Along with these side effects individuals with oral and oropharyngeal cancers can develop trismus defined as restricted mouth opening 35mmThe beneficial effects of early physical therapy programs in mitigating the incidence of trismus have not yet been fully established and there are no validated protocols or guidelines regarding exercise therapy The findings of this study will be crucial in developing effective rehabilitation strategies for patients with HNC and also will contribute to the development of tailored exercise programs and rehabilitation protocols enabling physical therapists specifically to deliver personalized care for individuals with HNC
2 Research question and Objectives i To evaluate the feasibility of a prospective surveillance approach for the early detection of trismus in patients with HNC ii To determine the acceptability of implementing an early physical therapy intervention which includes jaw and neck exercises manual therapy for the jaw and the use of a jaw device for managing trismus in individuals with HNC iii To explore the preliminary effectiveness of the intervention when compared with standard care on relevant outcomes such as mouth opening jaw and neck function and quality of life
3 Methodology This will be a pilot randomized feasibility trial involving 30 individuals with HNC who are undergoing radiation therapy - chemotherapy with or without prior surgery Participants will be identified at the HNC new patient clinic Those consenting will be randomized to either usual care UC or to prospective surveillance PS UC participants will receive active exercises and referral to physical therapy if trismus is detected Participants in the PS group will receive early intervention including manual therapy and a device-based jaw exercise regimen if presenting with 5 or greater reduction in jaw opening compared to pre-treatment
2 Research question and Objectives i To evaluate the feasibility of a prospective surveillance approach for the early detection of trismus in patients with HNC ii To determine the acceptability of implementing an early physical therapy intervention which includes jaw and neck exercises manual therapy for the jaw and the use of a jaw device for managing trismus in individuals with HNC iii To explore the preliminary effectiveness of the intervention when compared with standard care on relevant outcomes such as mouth opening jaw and neck function and quality of life
3 Methodology This will be a pilot randomized feasibility trial involving 30 individuals with HNC who are undergoing radiation therapy - chemotherapy with or without prior surgery Participants will be identified at the HNC new patient clinic Those consenting will be randomized to either usual care UC or to prospective surveillance PS UC participants will receive active exercises and referral to physical therapy if trismus is detected Participants in the PS group will receive early intervention including manual therapy and a device-based jaw exercise regimen if presenting with 5 or greater reduction in jaw opening compared to pre-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None