Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Head and Neck Neoplasms

Congenital Abnormalities

Abnormalities, Radiation-Induced

Radiation Injuries

Age-matched with the patient group, with no oral pathologies and comorbidities

Head-and-neck cancer patients who had undergone radiation therapy and developed late radiation side ffects

Alex I Vitkin, PhD

Radiation therapy of the head and neck cancer patients causes late oral radiation complications such as xerostomia (dry mouth) or mucosal atrophy. Currently, methods such as hyperbaric oxygen are used to treat these complications; however, there are no quantifiable means of assessing the outcome of these methods. At present, subjective methods such as superficial examination of the oral cavity are used, yet complications are known to mostly start in the subsurface layers. In this feasibility study, we apply an imaging technique called optical coherence tomography (OCT) as a means of providing objective and quantifiable images of the subsurface micro-structural and micro-vascular changes of oral tissue. Depth-resolved, micrometer-resolution OCT images provide information on changes associated with late radiation complications.

Patient imaging

At the imaging session, the patient will be asked to sit on the chair and put her/his chin on the chin-rest and the height of the chair will be adjusted accordingly. Before turning on the light source, the patient will be asked to wear the safety goggles and open her/his mouth while the probe is slowly moved inside the oral cavity. At this point, by looking at the superficial oral tissue, we will find regions in the oral cavity with superficial changes. When such regions are found, OCT images of these regions will be taken. Imaging of each location is expected to take about 3 to 4 minutes (including the time required to find the region of interest, acquisition of structural, Doppler and speckle variance images, and the time between each of these processes). After this, the patient can close her/his mouth and rest for couple of minutes. The same procedure will be performed on another site of complication. The 3-4 minute imaging procedure is repeated 3 to 5 times (depending on the patients' ability to keep the mouth open), after which the patient is dismissed and the sterile probe cover will be disposed. All the acquired data will be stored in a computer which is kept in a locked office. The data will be processed within the week after the imaging session so that structural, Doppler and speckle variance images of the imaged sites of complication can be compared.

During imaging, structural OCT real-time images are shown on the monitor to facilitate the task of finding the region of interest and keeping track of the patient's movements and move the probe accordingly. During the Doppler or speckle variance imaging (approximately 7 seconds each within the 3-4 minutes interval mentioned before), the patient is asked to keep as still as possible, in order to avoid any motion artifact in the OCT images.

Note that time frame for this study is 1 day, since subjects are only imaged once with no follow-up assessments.

Imaging healthy volunteers

The imaging session of the volunteers takes between 30 to 60 minutes. The imaging procedure of these healthy volunteers is very similar to that explained for the patients; however, all the acquired OCT images of this group would be of healthy oral tissue.

Note that time frame for this study is 1 day, since the volunteers are only imaged once with no follow-up assessments.

\*\*Important note: The aim of this study is to compare the images from patients with those of healthy volunteers and show that there are specific changes in the structural and vascular features of the patients (due to radiation toxicity) when compared to the volunteers. So, the comparison is done between the two cohorts of the study.

Data analysis

For the healthy volunteers, the gathered OCT data will be processed to form structural, Doppler and speckle variance images of healthy oral tissue to serve as a reference. The same procedure will be performed on late oral radiation toxicity patients to reconstruct structural, Doppler and speckle variance images of the site of oral complications. Then, the images of healthy volunteers and patients will be compared in terms of the layer thickness, the back-reflection properties of each layer, and the size and profile of blood flow of the microvasculature. In order to compare these two sets of images quantitatively, certain metrics will be defined based on the images of the healthy volunteers. All these quantitative comparisons of healthy oral tissue and tissue with radiation complication will be used to form an OCT atlas of oral radiation toxicity. Moreover, white-light images of the regions of OCT study will be taken in order to serve as a reference for the superficial complications caused by radiation.

Optical Coherence Tomography for Monitoring Late Oral Radiation Toxicity After Radiotherapy of Head and Neck Cancer Patients

Structural OCT images of the oral tissue of the late radiation toxicity patients will be taken and will be processed to highlight any differences between them and the healthy human oral tissue. An example of the expected differences (in the patients compared to healthy volunteers) is total loss of basal layer and thus loss of differentiation between epithelium and lamina propria in the patients.

Doppler OCT and speckle variance OCT images will be taken to reveal information on the blood flow and vascular structure, respectively. These images will be processed and information about the blood flow, size of the vasculature, and vessel density of the radiation toxicity patients will be extracted and the average values will be compared to those of healthy human volunteer cases

University Health Network, Toronto

Symptoms and General Pathology

Pain

The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; vein visibility, the catheter number used in the procedure, the time to identify the appropriate vein, the successful PIVC placement time, the number of attempts for successful catheter placement, the vein in which the catheter was placed, the pain and fear levels before, during and after the procedure. These data will be recorded in the data form regarding the PIVC application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. The vein imaging device will be opened with transilluminator, the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; the pain and fear levels before, during and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

The patient's vital signs, skin color, and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. Vein imaging will not be performed. No intervention will be carried out the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data will obtained on PIVC placement; the pain and fear levels before, during, and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

Experimental group - Vascular imaging device with the infrared light group: Before PIVC, infrared light will be directed to the vein area and the procedure will be started after vein visibility is achieved.

Experimental group - Vascular access transillumination group: Before PIVC, a transilluminator will be inserted to the vein area and the procedure will be started after vein visibility is achieved

Vascular imaging

Yasemin Karacan, PhD

Türkkan Evrensel, Prof, PhD

Purpose: This study will be conducted on the effect of infrared light on PIVC procedure fear, procedure pain, and patient satisfaction in oncology patients receiving chemotherapy treatment. The investigators will implement the study during the insert on PIVC; the vascular imaging device with the infrared light group; the vascular access transillumination group; and the control group.

Design: This is a prospective, randomized controlled experimental study.

The population of the research will be cancer patients who applied to Bursa Uludag University Medical Faculty Hospital Oncology unit between June 2023 and July 2025. The population of the study will consist of patients who applied to the Chemotherapy Unit in Bursa Uludağ University Health Research and Application Center Hospital Oncology Polyclinic for outpatient treatment. It is aimed to reach all patients who agreed to participate in the study and who met the inclusion criteria of the study, rather than using the research sample selection method. However, this data does not show the number of patients who applied to the unit because of the repeated visits of the patients during the chemotherapy treatment process. For this reason, direct sample selection was not made in the study, and the sample calculation was made according to the number of patients registered in the unit and the results of previous research. Calculations were made using the "G.Power-3.17" program with 95% confidence, an effect size of 0.4, and a statistical test power of at least 80%. Accordingly, it was aimed to reach 126 patients, at least 42 in each group.However, since the losses will be ignored, it is aimed to reach 150 patients in total. The hypotheses of the research;

H0,1: In patients receiving chemotherapy, the vein imaging device has no effect on the successful PIVC procedure by determining the appropriate vein.

H1,1: In patients receiving chemotherapy, the vein imaging device has an effect on the successful PIVC procedure by determining the appropriate vein.

H2: Vascular imaging device has a lower value in terms of pain in the PIVC procedure in patients receiving chemotherapy.

H3: In patients receiving chemotherapy, the vascular imaging device has a lower level of fear in the PIVC procedure.

H4: In patients receiving chemotherapy, vascular imaging device is higher in terms of patient satisfaction in PIVC procedure.

Implementation of the study in the vascular imaging device with the infrared light group: The patient will be taken to the chemotherapy application chair and rested. The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Since it is stated in the literature that the placement of the peripheral intravenous catheter in the unused arm is important in preventing complications, the PIVC procedure will be performed in the arm that the patient does not actively use. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse . The vein imaging device will be opened with infrared light, the tourniquet will be connected, and the vein visibility will be re-evaluated by the research nurse. As soon as the turnstile is connected, the stopwatch will be started. Then the PIVC placement process will be started with the help of the device. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the branule. If there is no blood, the attempt will be considered unsuccessful. In unsuccessful cases, the PIVC attempt will be repeated up to two times in each patient. All procedures will be performed by a single research nurse to ignore the operator hand manipulation difference. Data obtained on PIVC placement; Vein visibility, the catheter number used in the procedure, the time to identify the appropriate vein, the successful PIVC placement time, the number of attempts for successful catheter placement, the vein in which the catheter was placed, the pain and fear levels before, during and after the procedure. These data will be recorded in the data form regarding the PIK application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion. The satisfaction levels in the form will be evaluated on a scale ranging from 0 to 10, with 0: none, 10: many, after the application. These data will be recorded in the data form on PIVC transaction satisfaction.

Implementation of the study in the vascular access transillumination group: The processes will be repeated exactly. Transilluminator will be used instead of infrared light.

Implementation of the study in the control group: The processes will be repeated exactly. No intervention will be made for vascular access.

This is a prospective, randomized controlled experimental study.

The intervention and measurements will carried out by the researcher (for hand manipulation standard) and the patients will discovered their own groups when intervention will applied to them. Because of the nature of the intervention, blinding will not be performed.

The Effect of Infrared Light Use in Oncology Patients Receiving Chemotherapy

The Effect of Infrared Light Use on Pain, Fear, and Patient Satisfaction During Peripheral Intravenous Catheter (PIVC) Procedure in Oncology Patients Receiving Chemotherapy

Individual participant data (IPD) doesn't share any other researchers. Only research team will see data on IPD. After the data collection phase is completed and turned into a publication, other researchers can access the publication.

In this form, patients' satisfaction with the procedure will be evaluated using a visual comparison scale that can be graded from 1 to 10. It consists of questions created in line with the literature about how the nurse evaluates the patient's skills about the PIC procedure, how she evaluates your general PIC access experience, whether she sees herself as a patient with a history of DIFFICULT VASCULAR PATH, and whether the nurse who will perform PIC makes a comprehensive assessment of her veins (Eren and Çalışkan, 2021; Ramer et al., 2016). It includes minimum 0 point, maximum 10 points.

It is a one-dimensional scale used in the measurement of VAS pain. Among the one-dimensional scales used to determine the severity of pain in patients, it was determined that the VAS measures more sensitively and is more reliable. The scale consists of a 100 mm long horizontal line. On one end are the phrases "No Pain" and on the other end "Unbearable Pain" describing the most severe pain possible. The patient is asked to mark his pain on the scale.

The length of the line from the starting point of the scale to the point marked by the patient is measured and recorded in mm. It includes minimum 0 point, maximum 100 points.

It is a one-dimensional scale used in the measurement of VAS fear. Among the one-dimensional scales used to determine the severity of fear in patients, it was determined that the VAS measures more sensitively and is more reliable. The scale consists of a 100 mm long horizontal line. On one end are the phrases "No Fear" and on the other end "Unbearable Fear" describing the most severe fear possible. The patient is asked to mark his/her fear on the scale.

The length of the line from the starting point of the scale to the point marked by the patient is measured and recorded in mm. It includes minimum 0 point, maximum 100 points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optical Coherence Tomography for Monitoring Late Oral Radiation Toxicity After Radiotherapy of Head and Neck Cancer Patients	NCT01692600	Abnormalities, ...		18 Years -	University Health Network, Toronto
The Effect of Infrared Light Use in Oncology Patients Receiving Chemotherapy	NCT05892978	Pain Fear Needles Satisfaction, P...	Vascular imagin...	18 Years - 74 Years	Uludag University

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