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

Mouth and Tooth Diseases

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Vasodilator Agents

Respiratory System Agents

All Drugs and Chemicals

Herbal and Botanical

Nitric Oxide

Thyme

oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017)

oral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy.

thyme honey mouth rinse

saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy

saline mouth rinse

Susan Seif, professor

Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. Honey is one of the methods studied by CIM for management of HNC treatment side effects due to its properties. (Brennan et al., 2002; Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).

Thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. Due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.

28 post radiation cancer patients were randomly assigned into two equal groups.The intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Patients in the control arm followed the same protocol with normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (Charalambous et al., 2017).

Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et al., 2020).

Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients

Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients A Randomized Controlled Clinical Trial With a Biochemical Assessment

Q1. Do you feel dryness in your mouth ? Q2. Do you drink liquids to help you swallow dry food? Q3. Do you feel mouth dryness when eating a meal? Q4. Does the saliva seem to be too little in your mouth? Subjects who answered confirmatively to at least one of those questions related to dry mouth will be considered as positive for oral dryness subjective complaints.

Objective dry mouth score:

The patients will be examined for their signs of dry mouth including:

(Osailan et al., 2011).

1. pooled saliva loss
2. stickiness of mouth mirror to buccal mucosa
3. stringy or foamy appearance of saliva
4. dehydration of the lips
5. no response to parotid stimulation Calculation of Objective dry mouth scores will be according to the number of dry mouth signs observed (0-5) and patients with less than 2 score will be excluded

identification of PH according to the color of the PH paper

assessment of nitric oxide levels in the salivary samples using ELISA

assessing unstimulated salivary flow rate in 5 minutes

Ain Shams University

teaching assistant of oral medicine and periodontology

Behaviors and Mental Disorders

Quality of Life

Provides computerized PRO to the treating physician at the point of care

Provide computerized PRO (Patient Reported Outcome) to treating physician at the point of care to assess late effects after head and neck cancer

WebCan

Christoffer Johansen, Professor

Patient-reported information on outcomes such as symptom-burden and health-related quality of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer research. However, integrating patient-reported information in the routine clinical practice is often difficult due to excessive time use and practical barriers. Electronic data acquisitions, where the treating physician has immediately access to the patient-reported data in the subsequent consultation, have been shown to be beneficial in the everyday clinical decision making.

The aim of this study is to develop and test a computer-based patient-reported assessment tool that will assist the clinicians in tracking long term and late effects in head and neck cancer patients and investigate if the tool leads to improved symptom assessment of a range of head and neck cancer specific symptoms, which again may lead to improved symptom control and enhanced quality of life in the patients.

Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics at Herlev Hospital and physicians and nurses who work at the clinic will be invited to participate. The assessment tool will be developed with inspiration from prior international studies of symptom assessment in head and neck cancer patients and tailored so that it will fit into a Danish context. The tool will be tested in a controlled intervention study. In the intervention group, patients will complete the assessment tool in the patients waiting area prior to every scheduled consultation. The result will then be printed and provided to the treating physician. In the control group, the patients will complete the assessment tool prior to consultations. However, the data will not be provided to the physicians at any time.

To assess the impact of the tool on number of symptoms addressed during consultations and patients' overall quality of life, medical records will be reviewed for before start of intervention and again at 6 and 12 months follow-up. The patients will also complete the EORTC QLQ-C30 and the EORTC QLQ-H\&N35 at baseline and at 6 and 12 months follow-up. Furthermore, we will conduct a qualitative evaluation (semi structured interview and participant observations) of attitudes among clinicians and patients regarding the use of tool at the point of care.

Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care

Quality of life at baseline and 12 months follow-up

The Ministry of Science, Technology and Innovation, Denmark

Sygekassernes Helsefond

Danish Cancer Society

Phd student

Antineoplastic Agents

Cisplatin

All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment

The patients will undergo 5 DXA scans fro pre- to post treatment

DXA scan

The patients will undergo tests for maximal muscle strength and functional performance before and after treatment

Physical testing

Simon Lønbro, PhD

The goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. The main questions it aims to answer are: What is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? Is the lean body mass loss impacted by adding chemotherapy to the radiation treatment? Participants will be asked to undergo five body composition scans during treatment and undergo tests for muscle strength and functional performance before and after treatment.

The primary aim of the present study is to investigate the rate of decline in body composition (LBM, body weight and fat mass) as well as changes in maximal muscle strength and functional performance during radiation treatment in HNSCC patients and to investigate the association between the loss of LBM and impairments in maximal muscle strength and functional performance. Secondly, the study investigates whether adding cisplatin during chemoradiation induces exacerbated LBM loss compared to radiation alone.

50 patients are expected to be included in the study. Inclusion criteria are: (1) histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity, (2) prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy. Exclusion criteria were palliative radiation or participation in competing research protocols.

Five times during treatment (biweekly), patients will be asked to undergo a Dual Energy X-ray Absorptiometry scan to evaluate changes in lean body mass and fat mass. Before and after treatment patients are asked to perform three test for maximal muscle strength (one repetition maximum knee extension, chest press and leg press) as well as three functional performance test (30 s arm curl, 30 s chair rise and stair climb).

Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation

One repetition maximum in knee extension (unilateral), leg press (unilateral) and chest press (bilateral)

The fastest walking/running time in a stair climb test is recorded (two flights of stairs)

The maximum number of repetitions in 30 s arm curl test are recorded

The maximum number of repetitions in 30 s chair rise test are recorded

Lean body mass in kg determined by DXA scans

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients	NCT05859711	Head and Neck C...	thyme honey mou... saline mouth ri...	25 Years - 65 Years	Ain Shams University
Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care	NCT01803061	Head and Neck C... Late Effects	WebCan	-	Danish Cancer Society
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation	NCT05890859	Head and Neck C... Lean Body Mass Body Compositio...	DXA scan Physical testin...	18 Years -	Department of Public Health, Denmark
Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care	NCT01803061	Head and Neck C... Late Effects	WebCan	-	Danish Cancer Society
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation	NCT05890859	Head and Neck C... Lean Body Mass Body Compositio...	DXA scan Physical testin...	18 Years -	Department of Public Health, Denmark

Spots Global Cancer Trial Database for head and neck cancer patients