Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05036902
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2021-08-23
Brief Title:
The Impact of Multimodality Treatment on Physical Functions and Quality of Life in Patients With Head and Neck Cancer
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
The Impact of Multimodality Treatment on Physical Functions and Quality of Life in Patients With Head and Neck Cancer A Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral cancer including the lip alone with 300373 cases worldwide in 2012 is the predominant head and neck squamous cell carcinoma With an incidence of 65 cases per 100000 south - east asia has the highest incidence worldwide Many of these cases do present at a locally advanced stage which often requires combined modality treatment that includes extensive surgery to the primary site and neck and flap reconstruction This is often followed by either adjuvant radiation or chemo-radiotherapy This treatment can come with a significant morbidity affecting the self-care ability of the patients as well as impact the quality of lifeQOL 34At the SingHealth Duke - NUS Head and Neck Centre 340 complex cases of head and neck cancer HNC involving flap reconstructions and extensive resections have been operated in 2014 alone Almost all of these patients need further adjuvant treatment radiotherapy andor chemotherapy Side-effects following such treatments Significant number of patients underwent subsequent adjuvant treatment The adjuvant treatment and surgery may render these patients weakness of the shoulder and neck muscles numbness and reduced sensation around the neck and shoulder region and a general impact on the patients fitness While survival remains the most important outcome in oncologic treatment recovery of treatment related morbidity and return to pre-treatment QOL for patients after cancer treatment is equally important
The aims of this study is to evaluate the impact of surgical and adjuvant treatment on physical functions and QOL of the patients By measuring the impact of extensive treatments for head and neck malignancies on the fitness and QOL of these patients the team aims to identify the risk factors that necessitate a more aggressive rehabilitation This is to date the first prospective study investigating the impact of multimodality treatment on fitness and QOL in HNC patients in a structured and predefined manner Ultrasound US elastography will be used to assess muscle and soft tissue stiffness and elasticity and correlate these with functional outcome measurements Elastography has been previously described as a useful tool to assess stiffness of the neck soft tissues and muscles however no study thus far has correlated these findings with functional measurements Hence this trial aims to establish the following
1 Due to the limited available data to quantify and qualify the impact of surgery as well as adjuvant treatment on the fitness physical function of the neck and shoulder QOL of HNC patients
2 To establish a workflow and assessment protocol for a subsequent larger prospective clinical trial
3 To identify performance markers in these patients that allow a more targeted rehabilitation process
4 Many patients post head and neck treatment are economically compromised since they are unable to return to mainstream work and there exists a significant unemployment rate The understanding we gain through objective analysis apart from targeted treatment for every individual patient in the future this study hopes to address and improve the economic impact to the individual and probably reduce the health care burden
The aims of this study is to evaluate the impact of surgical and adjuvant treatment on physical functions and QOL of the patients By measuring the impact of extensive treatments for head and neck malignancies on the fitness and QOL of these patients the team aims to identify the risk factors that necessitate a more aggressive rehabilitation This is to date the first prospective study investigating the impact of multimodality treatment on fitness and QOL in HNC patients in a structured and predefined manner Ultrasound US elastography will be used to assess muscle and soft tissue stiffness and elasticity and correlate these with functional outcome measurements Elastography has been previously described as a useful tool to assess stiffness of the neck soft tissues and muscles however no study thus far has correlated these findings with functional measurements Hence this trial aims to establish the following
1 Due to the limited available data to quantify and qualify the impact of surgery as well as adjuvant treatment on the fitness physical function of the neck and shoulder QOL of HNC patients
2 To establish a workflow and assessment protocol for a subsequent larger prospective clinical trial
3 To identify performance markers in these patients that allow a more targeted rehabilitation process
4 Many patients post head and neck treatment are economically compromised since they are unable to return to mainstream work and there exists a significant unemployment rate The understanding we gain through objective analysis apart from targeted treatment for every individual patient in the future this study hopes to address and improve the economic impact to the individual and probably reduce the health care burden
Detailed Description:
The investigators will conduct a prospective cohort study by recruiting patients who are admitted to NCCS for HNC surgery It will be a pilot study targeting 10 patients to compare physical functions and QOL 1 to 2 weeks pre-surgery 3-6 weeks post-surgery and 6 months post-surgery The results from phase I will be used to plan the sample size for the following phase Each visit will take approximately 4 hours
Assessment of Physical Functions
1 Shoulder Range of Motion ROM and strength for both arms 1 hour
Routinely practiced by Physiotherapists as a part of evaluation for any patient referred for shoulder physiotherapy These will be measured by the Dynamometer Biodex S4 Pro with patients in a seated position Active and passive shoulder movements include abduction adduction and flexion and extension internal and external rotation Strength test of the upper and lower limbs will also be performed using an isometric hand-held dynamometer The measures will be done in the positions stated below
1 Bilateral knee extension at 90 degree knee flexion Unit measure kg
2 Bilateral shoulder flexion at 45 degree shoulder flexion Unit measure kg Shoulder Pain and Disability Index SPADI questionnaire will also be administered to evaluate shoulder pain and impairment
2 Point of gaze measurement 30 mins
A non-invasive assessment tool to assess head and neck movement Head range of movement will be assessed pre and post treatment using a light source together with the motion capture system Participants will be seated in the middle of the room with reflective markers placed on their head and shoulder The participants will keep their gaze fixed on the light source and then rotate the head as far as possible without losing gaze fixation The light source will move in different planes This will allow the impact of surgical treatment on head and neck mobility to be assessed Head movement relative to the thorax will be measure in 3 dimensions Restrictions in flexion lateral flexion and rotation will be quantified along with angular velocity and acceleration
3 Muscle activation patterns will also be evaluated using EMG 30 mins
Routinely practiced in physiotherapy
Sternocleidomastoid muscle
Sternal head and clavicular head on cervical contralateral rotation and ipsilateral cervical flexion
Serratus anterior
Supine shoulder at 90 flexion elbow fully extended - Resistance applied into shoulder retraction
Rhomboid major muscle
Prone head rotated ipsilaterally - Scapula adducted and elevated Elbow fully flexed shoulder extended and adducted Resistance applied into shoulder abduction and depression
Upper trapezius muscle
Scapula elevation in sitting - Resistance applied into shoulder depression and cervical spine contralateral flexion
Middle trapezius muscle
Scapula elevation in sitting - Resistance applied into shoulder depression and cervical spine contralateral flexion
4 Grey-scale B-mode ultrasound and Shear-wave elastography imaging 1 hour Non-invasive and of standard clinical care practice however elastography a non-invasive test is a new dimension to this test to assess the density and rigidity of muscles practised in the area of breast surgery and new application for head and neck cancer patients
To allow assessment of tissue stiffness via elastography the following protocol will be employed
Grey-scale and shear-wave ultrasound elastography will be performed at baseline pre-op 4-weeks and 6-months post-op All examinations will be performed with the patient supine and neck extended using the SuperSonic ultrasound machine Aixplorer SuperSonic Imagine Aix-En-Provence France that equipped with a 15-MHz superficial linear transducer
Grey-scale B-mode ultrasound
The examination will begin with grey-scale ultrasound to assess the sternocleidomastoid SCM or trapezius muscle thickness In order to ensure consistency in image acquisition and reproducibility of the ultrasound scans at follow-up the thickness of the SCM or trapezius muscle will be measured on the longitudinal plane at the of the upper edge of the thyroid cartilage
The thickness measurement will be repeated once ie 2 sets of thickness measurements will be obtained and the mean values will be recorded for final analysis
After recording the grey-scale images real-time shear-wave elastography will be obtained with the participants in the same position
Shear-wave elastography imaging
On longitudinal image the SCM or trapezius muscle will be divided into proximal mid and distal sections The shear-wave elastography imaging mode will be activated
A rectangular acquisition box displaying the color map of differential tissue stiffness red stiff area blue soft area and greenyellow intermediate stiffness will be placed in the centre of the field of view The shear-wave velocity in meters per second will be measured on the longitudinal shear wave image by placing a circle ROI that covers almost the entire muscle tissues in the rectangular acquisition box
The shear-wave image acquisition will be repeated for mid and distal third SCM sections 2 sets of muscle velocity msec and elasticity kpasc values will be recorded for each SCM section The mean of the measurements will be used for final analysis Note The velocity of shear wave propagation is directly related to tissue stiffness Velocity increases with stiffness The entire length of SCM muscle is approximately 13-15cm The transducer length is 5cm The investigators divide each SCM muscle into thirds for evaluation to allow overlapping scans and maximise assessment of SCM muscle stiffness
5 Fitness
Treadmill Modified Bruce protocol 45 mins
Treadmill is a time tested test as a part of cardiac and pre-anesthetic work up however in this study the application is new perspective to assess fitness in head and neck cancer patients The modified Bruce commenced at 27kmh at 0 incline for 3 minutes followed by 27kmh at 5 incline for 3 minutes before going to the next stage which is the real STAGE 1 of the Bruce protocol As for estimating the VO2- there is a linear relationship between HR and VO2 peak or HRR and VO2R provided the subjects HR is not attenuated eg those on beta blockers
6-minute walk test 6MWT 10 mins For the 6MWT subjects are require to walk laps of 20m at the fastest they are able to perform over the period of 6 minutes Subjects would be allowed to stop and rest within the allocated time period
1 Total distance Unit measure m
2 Predicted distance Unit measure
3 Predicted VO2 max Unit measure mLkgmin 6 Assessing sensory loss secondary to incision flap elevation and adjuvant therapy 5 mins Routinely practised in Neurology the application specifically for head and neck cancer patients is focused way of assessing post-operative outcome may not be routinely practiced
Mapping Sensory Loss Dermatomes C2 to T5 via the sharp blunt test as routinely used in neurological assessment 7 Assessment of QOL 10 mins Has been routinely practiced in head and neck cancer and is a component of standard clinical care however not mandatory
QOL will be evaluated by administering the evaluated SPADI EORTC QLQ HN35 and EORTC QLQ C30 questionnaires which are already used as part of the general QOL assessment of the head and neck cancer patients in the Singhealth DukeNUS Head Neck Centre Besides the assessments all subjects will undergo physiotherapy intervention approx 1 hour immediately after surgery once stable and allowed by the medical team all subjects will be ambulated as tolerated as per post-operative protocol
Two weeks after surgery or when allowed by medical team whichever is later the subjects will be guided to progress follow the work-out with the following routine for the period of three to six months post-surgery
Assessment of Physical Functions
1 Shoulder Range of Motion ROM and strength for both arms 1 hour
Routinely practiced by Physiotherapists as a part of evaluation for any patient referred for shoulder physiotherapy These will be measured by the Dynamometer Biodex S4 Pro with patients in a seated position Active and passive shoulder movements include abduction adduction and flexion and extension internal and external rotation Strength test of the upper and lower limbs will also be performed using an isometric hand-held dynamometer The measures will be done in the positions stated below
1 Bilateral knee extension at 90 degree knee flexion Unit measure kg
2 Bilateral shoulder flexion at 45 degree shoulder flexion Unit measure kg Shoulder Pain and Disability Index SPADI questionnaire will also be administered to evaluate shoulder pain and impairment
2 Point of gaze measurement 30 mins
A non-invasive assessment tool to assess head and neck movement Head range of movement will be assessed pre and post treatment using a light source together with the motion capture system Participants will be seated in the middle of the room with reflective markers placed on their head and shoulder The participants will keep their gaze fixed on the light source and then rotate the head as far as possible without losing gaze fixation The light source will move in different planes This will allow the impact of surgical treatment on head and neck mobility to be assessed Head movement relative to the thorax will be measure in 3 dimensions Restrictions in flexion lateral flexion and rotation will be quantified along with angular velocity and acceleration
3 Muscle activation patterns will also be evaluated using EMG 30 mins
Routinely practiced in physiotherapy
Sternocleidomastoid muscle
Sternal head and clavicular head on cervical contralateral rotation and ipsilateral cervical flexion
Serratus anterior
Supine shoulder at 90 flexion elbow fully extended - Resistance applied into shoulder retraction
Rhomboid major muscle
Prone head rotated ipsilaterally - Scapula adducted and elevated Elbow fully flexed shoulder extended and adducted Resistance applied into shoulder abduction and depression
Upper trapezius muscle
Scapula elevation in sitting - Resistance applied into shoulder depression and cervical spine contralateral flexion
Middle trapezius muscle
Scapula elevation in sitting - Resistance applied into shoulder depression and cervical spine contralateral flexion
4 Grey-scale B-mode ultrasound and Shear-wave elastography imaging 1 hour Non-invasive and of standard clinical care practice however elastography a non-invasive test is a new dimension to this test to assess the density and rigidity of muscles practised in the area of breast surgery and new application for head and neck cancer patients
To allow assessment of tissue stiffness via elastography the following protocol will be employed
Grey-scale and shear-wave ultrasound elastography will be performed at baseline pre-op 4-weeks and 6-months post-op All examinations will be performed with the patient supine and neck extended using the SuperSonic ultrasound machine Aixplorer SuperSonic Imagine Aix-En-Provence France that equipped with a 15-MHz superficial linear transducer
Grey-scale B-mode ultrasound
The examination will begin with grey-scale ultrasound to assess the sternocleidomastoid SCM or trapezius muscle thickness In order to ensure consistency in image acquisition and reproducibility of the ultrasound scans at follow-up the thickness of the SCM or trapezius muscle will be measured on the longitudinal plane at the of the upper edge of the thyroid cartilage
The thickness measurement will be repeated once ie 2 sets of thickness measurements will be obtained and the mean values will be recorded for final analysis
After recording the grey-scale images real-time shear-wave elastography will be obtained with the participants in the same position
Shear-wave elastography imaging
On longitudinal image the SCM or trapezius muscle will be divided into proximal mid and distal sections The shear-wave elastography imaging mode will be activated
A rectangular acquisition box displaying the color map of differential tissue stiffness red stiff area blue soft area and greenyellow intermediate stiffness will be placed in the centre of the field of view The shear-wave velocity in meters per second will be measured on the longitudinal shear wave image by placing a circle ROI that covers almost the entire muscle tissues in the rectangular acquisition box
The shear-wave image acquisition will be repeated for mid and distal third SCM sections 2 sets of muscle velocity msec and elasticity kpasc values will be recorded for each SCM section The mean of the measurements will be used for final analysis Note The velocity of shear wave propagation is directly related to tissue stiffness Velocity increases with stiffness The entire length of SCM muscle is approximately 13-15cm The transducer length is 5cm The investigators divide each SCM muscle into thirds for evaluation to allow overlapping scans and maximise assessment of SCM muscle stiffness
5 Fitness
Treadmill Modified Bruce protocol 45 mins
Treadmill is a time tested test as a part of cardiac and pre-anesthetic work up however in this study the application is new perspective to assess fitness in head and neck cancer patients The modified Bruce commenced at 27kmh at 0 incline for 3 minutes followed by 27kmh at 5 incline for 3 minutes before going to the next stage which is the real STAGE 1 of the Bruce protocol As for estimating the VO2- there is a linear relationship between HR and VO2 peak or HRR and VO2R provided the subjects HR is not attenuated eg those on beta blockers
6-minute walk test 6MWT 10 mins For the 6MWT subjects are require to walk laps of 20m at the fastest they are able to perform over the period of 6 minutes Subjects would be allowed to stop and rest within the allocated time period
1 Total distance Unit measure m
2 Predicted distance Unit measure
3 Predicted VO2 max Unit measure mLkgmin 6 Assessing sensory loss secondary to incision flap elevation and adjuvant therapy 5 mins Routinely practised in Neurology the application specifically for head and neck cancer patients is focused way of assessing post-operative outcome may not be routinely practiced
Mapping Sensory Loss Dermatomes C2 to T5 via the sharp blunt test as routinely used in neurological assessment 7 Assessment of QOL 10 mins Has been routinely practiced in head and neck cancer and is a component of standard clinical care however not mandatory
QOL will be evaluated by administering the evaluated SPADI EORTC QLQ HN35 and EORTC QLQ C30 questionnaires which are already used as part of the general QOL assessment of the head and neck cancer patients in the Singhealth DukeNUS Head Neck Centre Besides the assessments all subjects will undergo physiotherapy intervention approx 1 hour immediately after surgery once stable and allowed by the medical team all subjects will be ambulated as tolerated as per post-operative protocol
Two weeks after surgery or when allowed by medical team whichever is later the subjects will be guided to progress follow the work-out with the following routine for the period of three to six months post-surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None