Behaviors and Mental Disorders

All Conditions

Neoplasms

Wounds and Injuries

Depression

Depressive Disorder

Head and Neck Neoplasms

Radiation Injuries

Behavioral Symptoms

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Vortioxetine

Antidepressive Agents

Anti-Anxiety Agents

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Serotonin 5-HT1 Receptor Agonists

Serotonin Receptor Agonists

Serotonin 5-HT3 Receptor Antagonists

On the basis of general psychotherapy, cognitive behavior therapy and supportive psychotherapy, the patients were given votioxetine 10mg/tablet, one tablet each time, once a day, for 2 months.

On the basis of general psychotherapy, cognitive behavior therapy and supportive psychotherapy, the patients were given placebo, one tablet each time, once a day, for 2 months.

Vortioxetine will be used with a dosage of 10mg once a day, for 2 months.

Vortioxetine 10 mg

Placebo will be used with a dosage of one tablet once a day for 2 months.

Placebo

Yamei Tang, M.D.

Yamei Tang

The purpose of this study is to evaluate the effects of vortioxetine, once daily (QD), on mood disorders and cognitive dysfunction in patients with head and neck cancers undergoing radiotherapy.

Head and neck cancer (HNC) is the fifth most common cancer in the world, especially in South China. The incidence of depression and anxiety in HNC patients after radiotherapy is as high as 12% - 45% due to appearance changes, decreased swallowing function, dry mouth, pain and other discomfort. At the same time, radiotherapy, as mainstay of therapy for HNC, also causes different degrees of damage to the brain around the tumor, leading to secondary cognitive dysfunction. Depression, anxiety and cognitive impairment seriously affect the quality of life of HNC patients after radiotherapy. Recent studies have found that votioxetine has multimodal pharmacodynamic activity, which can not only improve symptoms of depression, but also significantly improve the cognitive function of patients. In this study, investigators will discuss the therapeutic effect of vortioxetine on the depression after radiotherapy in HNC patients through a multi-center, randomized and double-blind comparative clinical trial.

Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy

A Multicenter, Randomized, Double-blind, Controlled Clinical Trial of Votioxetine in the Treatment of Depression After Radiotherapy for Head and Neck Cancer

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms.

The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Higher scores-correct number of symbols reflects greater objective cognitive functioning.

The purpose of the RAVLT is to assess verbal learning and memory. Specifically, it assesses immediate memory span, new learning, susceptibility to interference, and recognition memory.

TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Lower scores represent better speed of processing.

MADRS response was defined as a ≥50% decrease in MADRS total score from baseline

HAM-A is a widely used and well-validated tool for measuring the severity of a patient's anxiety, Higher scores indicate greater severity of symptoms.

Change from baseline to 8 weeks and endpoint mean scores in FACT-H\&N (the Functional Assessment of Cancer Therapy-Head and Neck) Scale，Higher scores indicate greater severity of symptoms.

The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill).

Number of participants who dropped out due to adverse events during the trial

Number of participants who dropped out due to inefficacy during the trial

Sun Yat-sen University

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Brain Hospital Affiliated to Guangzhou Medical University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Professor

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Prostatic Neoplasms

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy at

1. Radiumhemmat, Karolinska University Hospital and
2. Jubileumskliniken at Sahlgrenska University Hospital in Sweden.

Prostate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy

Radiotherapy

Gunnar Steineck

The investigators plan to investigate the consequences of late effects (radiation-induced survivorship syndromes) after radiotherapy in Gynecological and Prostate cancer survivors on return to work (Yes/No) and if RTW happened then time to RTW.

In addition, whether general health, type of work (occupation), work environment factors, individual factors (lifestyle, socioeconomic status etc.), contribute to the adverse late effects of radiotherapy and these Gynecological cancer survivors have a higher risk for disability pension/long term sickness absence (NOT Return to work).

Occurrence of cancer diagnoses are rising, and both disease and treatments are aggressive. Due to advancement in medical technology, improved therapy and/or early detection the overall survival rates are also improving.

Some of the most common cancer types, such as breast cancer, prostate cancer, cervical cancer, and colorectal cancer have high cure rates when detected early and treated according to best practices. Many of these cancer survivors are of working age and are likely to return to work. Women who survive cervical cancer and men who survive testicular cancer typically have three to four decades left in working life.

However, return to work (RTW) among cancer survivors may not be similar to RTW among long-term sickness absentees due to other diagnoses. Cancer is a life threatening disease and cancer diagnose is a life changing event. The emotional shock after the cancer diagnosis may be associated with low psychological well-being even two years after prostate cancer surgery.

The successful cancer treatment concludes with the lifelong consequences of surgery, irradiation, cytotoxic chemotherapy, biological anticancer substances or other drugs in the treatment. The ionizing radiation that eliminates malignant cells may trigger long-lasting pathophysiological processes in the normal tissue and affect the health of the survivors with lifelong treatment-induced survivorship diseases. In a recent study, Steineck et al, identified five radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer; urgency syndrome (30%), leakage syndrome (26%), excessive gas discharge(15%), excessive mucus discharge (16%) and blood discharge (10%).

There is a lack of knowledge about how these side effects of cancer treatment affect the degree of work ability and return to work. Clinical experience suggests that many cancer survivors have reduced work ability. There is a need for scientific studies that shed light on the side effects of cancer treatment and their relation to work ability.

Gyaecological cancer survivors Prostate cancer survivors

Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes

Information on Sickness absence for more than 14 days was obtained from the official registries in Sweden.

Sickness absence (more than 14 days) until the survivor returned to work. Also obtained from the official registries in Sweden.

Vastra Gotaland Region

Sahlgrenska University Hospital, Sweden

Professor / Senior consultant

Inflammation

Fibrosis

Mitogens

This arm applies the developed rehabilitation assessment software by using two web cameras placed in the front and the side of the subject. The subject sits between two cameras. The observer asks the subject to move the head in each direction, to open the mouth, and to move the tongue. The software will measure CROM, mouth opening, and tongue movement.

This arm applies video-fluoroscopic swallowing (VFSS) and functional oral intake scale (FOIS) to measure the direct, dynamic view of oral, pharyngeal, and upper esophageal function during swallowing with food and liquid mixed with barium, and the functional intake of dysphagic patients, respectively.

In phase 2, this software will be tested in occupational therapists, and head and neck cancer patients results for reliability and validity.

In phase 3, the experiment in the oropharyngeal dysphagia specialists results in content validity, the comparison between the developed software, and VFSS and FOIS results in criterion-related validity, and the experiment in head and neck cancer patients results in reliability.

Rehabilitation assessment software

In phase 3, this study applies VFSS and FOIS for the head and neck cancer patients for comparison with the developed rehabilitation assessment software for criterion-related validity.

VFSS and FOIS

Panrasee Ritthipravat

The current cervical range of motion (CROM) and tongue movement measurement methods are not reliable between observers, which is not practical in real-world usage. This research is to develop the cervical range of motion measurement, and tongue movement estimation software, to compare between the developed software and the current measurement techniques, and to test in clinical aspects for reliability and validity assessment. The investigators investigate the developed software in healthy people in phase 1. In phases 2 and 3, the investigators compare the software to the standard measurement methods in dysphagic patients who have head and neck cancer for reliability and validity.

Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients

The data requires to be confidential. It is prohibited to share the participant-level data.

The same investigator will repeat cervical range of motion measurement by using the developed rehabilitation software and the standard cervical range of motion (CROM) measurement method from the goniometer.

The cervical range of motion (CROM) measurement by using the developed rehabilitation software and the standard CROM measurement method from the goniometer will be repeated by different observers.

The correlation of the concurrent cervical range of motion (CROM) measurement outcome at approximately the same time between the developed rehabilitation assessment software and the standard CROM measurement method from the goniometer.

The criterion-related validity of the rehabilitation assessment software will be assessed by the correlation between the cervical range of motion measurement by the developed rehabilitation assessment software and the functional swallowing assessment by videofluoroscopic Swallowing Study (VFSS), and functional oral intake scale (FOIS).

Mahidol University

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Skin and Connective Tissue Diseases

Substance Related Disorders

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm Metastasis

Breast Neoplasms

Lymphoma

Leukemia

Drug-Related Side Effects and Adverse Reactions

Cardiotoxicity

Chemically-Induced Disorders

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Heart Diseases

Breast Diseases

Skin Diseases

Lymphosarcoma

Chronic Graft Versus Host Disease

Intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care.

Current clinical practice: cardiac care is based on the onco-hematologist criteria.

Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years).

Assessment protocol: Anamnesis and physical examination; EKG; Echocardiogram; Biomarkers (troponin and natriuretic peptide); Structured counselling on healthy cardiac practices; Treatment optimization of cardiovascular risk factors and heart diseases; Quality of life (ECOG Performance status and Minnesota questionnaires); Interaction and management of patient care by the cardio-onco-hematology team. Moreover, cardiac MRI in centers participating in the CARTIER-MR sub-study.

Intensive cardiovascular monitoring

Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years).

Assessment protocol: Anamnesis and physical examination; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria

No intervention

Pedro L Sánchez, Ph. D.

Ana Martín-García, Ph. D.

Pilar Mazón-Ramos, MD

Sonia Velasco, MD

Ignacio Ferreira-González, MD

Dolores Mesa, MD

Fernando Alfonso-Manterola

Fernando Alfonso-Manterola, Md

Eduardo Zatarain-Nicolás

Eduardo Zatarain-Nicolás, MD

Ana Pardo-Sanz, MD

Luis F Navarro-del-Amo, MD

Carmen Jiménez-López-Guarch, MD

Cristina Mitroi, MD

Juan J Gómez-Doblas

Juan J Gómez-Doblas, MD

Gonzalo Baron-Esquivias

Gonzalo Baron-Esquivias, MD

Marina Revilla-Martínez, MD

The CARTIER study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria).

The primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality.

Other secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and/or urgent care due to cardiovascular complications, hospitalization and/or urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis.

A total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited.

The incidence of primary and secondary outcomes will be measured at 2 and 5 years

Randomized, multicenter, open-label clinical trial comparing, in elderly patient with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies

Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)

Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies

Cumulative incidence of all-cause mortality

Cumulative incidence of oncological mortality

Cumulative incidence of cardiovascular mortality

Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause

Cumulative incidence of hospitalization and/or emergency care for cancer cause

Incidence of tumoral recurrence or progression

Instituto de Investigación Biomédica de Salamanca

Instituto de Salud Carlos III

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Dermatitis

Radiodermatitis

Quality of Life

The control group will have usual care according to the orientation of the radiation therapy faculty responsible for the radiotherapy treatment the PBM device will be switched off

Additionally to the usual care, the patients will receive the PBM. Treatment will be done twice a week.

Photobiomodulation will be with the Cicatrillux (Cosmedical®) LED that contains 36 red light emitters in a 10x12 cm neoprene plate with 650 nm LED wave length whose optical spot diameter is 5 mm and with an average wave length of 2 \~ 5 mw for 10 minutes that will be placed over the area that will be irradiated for 10 minutes;

Photobiomodulation

Glauco Baiocchi, MD, PhD

A prospective single blind controlled randomized trial to evaluate the superiority of photobiomodulation (PBM) using LED-therapy in reducing the prevalence of radiodermatitis in breast cancer compared to usual local care.

Breast cancer is the second most common cancer in the world, the most common among women in Brazil and accounts for approximately 25% of new cases of cancer in women. One of the pillars of treatment is the radiotherapy, being able to generate a toxic effect in the neoplastic cells and also deleterious in healthy cells, with early and late side effects, being radiodermatitis one of these affections. Moreover, radiodermatitis may cause discontinuation of radiotherapy until the skin is able to receive the appropriate dose. Photobiomodulation (PBM) is a non-invasive, a-thermal treatment modality based on the effect of light in biological systems leading to the activation of epithelial healing through the modulation of several metabolic processes through photochemical reactions. PBM use in an oncologic setting has become an interesting object of study in recent years and even though there are different possibilities for the use in breast cancer and physicians are not yet familiar with this therapy. Several in vitro studies with different cell types ranging from keratinocytes, endothelial cells and fibroblasts have been performed showing that PBM is capable of enhancing cell migration, proliferation, local metabolism, inducing collagen synthesis and secretion of growth factors, self-regulation of the production of proinflammatory cytokines and cellular apoptosis, aiding in the recovery of the dermis and epidermis. The aim of this study will be to evaluate the superiority of the use of photobiomodulation using LED-therapy in relation to the development of radiodermatitis in breast cancer compared to usual local care.

The study will included 110 women after informed consent will be randomly assigned into two groups. There will be 11 groups of 10 envelopes each, where each group will contain a code that allocates patients in group A (05 patients) and group B (05 patients). After the allocation of the 10 patients, a new envelope group will be available until the total number of patients scheduled for this study is reached (110, 55 in each group). Group A (GA) will be the control group of usual care according to the orientation of the radiation therapy clinic responsible for the radiotherapy treatment and with the use of the PBM device switched off. Group B (GB) will be the intervention group, which in addition to the usual care oriented in the radiotherapy clinic responsible for the radiotherapy treatment will use the attached PBM. Both groups will use a pair of glasses that will block the visualization of the light emitted by the PBM device, precisely so that they do not know in which research group it is located. Treatment will be done twice weekly, Tuesday and Thursday. The Photobiomodulation will be with the Cicatrillux (Cosmedical®) LED that contains 36 red light emitters in a 10x12 cm neoprene plate with 650 nm LED wave length whose optical spot diameter is 5 mm and with an average wave length of 2 \~ 5 mw for 10 minutes that will be placed over the area that will be irradiated for 10 minutes; the LED board will be wrapped in a plastic film that will be changed between each use. Both, the control group and the intervention group, will be evaluated for radiodermatitis by the oncologist who accompanies them and by a nurse, and both evaluators will not know in which group the person evaluated belongs. Concomitant to the radiotherapy sessions, both groups will be evaluated by a clinical and sociodemographic questionnaire, by the "Behavioral Risk Factor Surveillance System" (BRFSS), by the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) by the Analog Visual Scale for Pain, Radiodermatitis Assessment through the Radiation Therapy Oncology Group (RTOG), application of the European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire questionnaire (EORTC QLQ-BR23) and the European Organization for Research and Treatment of Cancer (EORTC QLQ-30), all questionnaires have already been translated and validated into the Portuguese language. The classification of radiodermatitis and pain assessment will be repeated 90 days after the start of radiotherapy. A descriptive and comparative analysis of the intervention groups will be performed in relation to the selected variables. The evaluation of the outcomes will be performed by intention to treat and by adherence to the protocol, through relative risk, and 95% confidence interval. To analyze the data will be used "Statistical Package for Social Sciences" (SPSS) v.23 Demo (SPSS Inc., Chicago, Illinois, United States). The McNemar test will be used to compare pain levels between groups. For inter-group assessments of the proportion of radiodermatitis, the chi-square test will be used to compare the intervention and control of the group.

Secondary objectives will be to describe the socio-demographic and clinical characteristics of the studied population; to evaluate the incidence of radiodermatitis in people with breast cancer, immediately after and 90 days post-radiotherapy according to study intervention group; to evaluate the adherence and satisfaction to treatment with PMB using LED-therapy in people with breast cancer; to compare the occurrence of pain and its graduation according to the intervention group, immediately after the radiotherapy and in the follow-up of 90 days in people with breast cancer; to evaluate the quality of life of people submitted to radiotherapy for breast cancer according to the intervention group and changes in radiotherapy treatment.

The inclusion criteria are women older than 18 years with histological diagnosis of breast cancer who underwent conservative surgery or mastectomy, without immediate breast reconstruction, treated with conventional radiotherapy referred by the oncologist who accompanies her regularly and who have availability of 20 minutes before the radiotherapy session to CORSB Radiation Therapy and Megavoltage to apply the LED-therapy and accept to participate in the research signing the Free and Informed Consent Term (TCLE). Patients who have undergone mastectomy with immediate breast reconstruction and those who suffer from collagen diseases will be excluded from this study.

The investigators hypothesized that photobiomodulation can stop the progression of radiodermatitis or lead to a faster cure, in turn, would have beneficial effects on the quality of life of these people. Then, it is expected that, at the end of radiotherapy sessions, people treated with therapy would have less severe skin reactions and higher quality of life when compared to people in the control group.

The participant and care provider will be blinded regarding the status of photobiomodulation device (if switched on or off).

Photobiomodulation for Breast Cancer Radiodermatitis

Photobiomodulation for Breast Cancer Radiodermatitis Prevention. A Randomized Controlled Trial.

"Radiation Therapy Oncology Group" (RTOG) grading

Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire

Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)

European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)

European Organization for Research and Treatment of Cancer (EORTC QLQ-30)

AC Camargo Cancer Center

Mouth and Tooth Diseases

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Therapeutic irradiation to the head and neck for cancer damages salivary glands present in the radiation field. Despite long recognition of radiation-induced salivary hypofunction, and the associated oral morbidities, the specific damage mechanism(s) is not known and the structure and functional integrity of the surviving parenchymal tissue has not been well-documented. Detailed knowledge of the latter is particularly necessary in order to design appropriate corrective therapies. It is the purpose of this study to provide such a detailed structural and functional assessment of human parotid glands following irradiation. The study will examine 20 patients beginning just prior to therapeutic irradiation and continuing at intervals for 3 years for a total of 5 study visits. Study visits (prior to irradiation and at 4 weeks, 12 weeks, 12 months and 36 months post-irradiation) will include the following procedures: i) detailed oral exam and structured interview; ii) salivary gland functional assessment; iii) sialography of each parotid gland; iv) 99mTcO4 scan of the salivary glands; and v) a magnetic resonance imaging (MRI) scan of the parotid glands. Based on previous single observation studies in humans, and more detailed animal studies, we hypothesize that ionizing radiation will lead to reduced parotid gland function and diminished salivary parenchymal tissue (with a preferential loss in acinar versus ductal cells). Further, we hypothesize that the parenchymal loss will increase with time (replaced by fat and connective tissue) and lead to progressive irreversible salivary dysfunction.

Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation

National Institute of Dental and Craniofacial Research (NIDCR)

Acute Graft Versus Host Disease

Receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

Receives PBMT (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

PBMT sessions will be planned 2x/week after RT.

Photobiomodulation therapy (PBMT)

Sham laser sessions will be applied 2x/week after RT.

Sham laser

Jolien Robijns, PhD

Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome.

Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation.

Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT.

The results of this project will support the implementation of PBMT into the standard RD skincare program.

Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy

The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial

Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0- 4)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS (0 - 4)

Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy	NCT04818099	Radiation Injur...	Vortioxetine 10... Placebo	18 Years - 65 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes	NCT03961217	Gynecologic Can... Prostate Cancer Radiation Toxic... Malignancy Radiotherapy Si... Radiation Injur... Cancer Survivor... Radiation Syndr...	Radiotherapy	25 Years - 60 Years	Sahlgrenska University Hospital, Sweden
Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients	NCT05141539	Healthy Head and Neck C...	Rehabilitation ... VFSS and FOIS	18 Years - 80 Years	Mahidol University
Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)	NCT03711110	Cancer (Colon C... Elderly Antineoplastic ... Cardiotoxicity	Intensive cardi... No intervention	65 Years -	Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients	NCT05141539	Healthy Head and Neck C...	Rehabilitation ... VFSS and FOIS	18 Years - 80 Years	Mahidol University
Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients	NCT05141539	Healthy Head and Neck C...	Rehabilitation ... VFSS and FOIS	18 Years - 80 Years	Mahidol University
Photobiomodulation for Breast Cancer Radiodermatitis	NCT04059809	Breast Cancer Radiodermatitis Radiotherapy Si... Radiation Derma... Radiation Toxic... Radiation Injur... Quality of Life Breast Neoplasm...	Photobiomodulat...	18 Years -	AC Camargo Cancer Center
Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation	NCT00001523	Radiation Injur... Xerostomia		-	National Institutes of Health Clinical Center (CC)
Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy	NCT03924011	Radiodermatitis Breast Cancer	Photobiomodulat... Sham laser	18 Years -	Hasselt University
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy	NCT04818099	Radiation Injur...	Vortioxetine 10... Placebo	18 Years - 65 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for radiation injuries