Behaviors and Mental Disorders

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Anxiety Disorders

Depressive Disorder

Depression

Chronic Pain

Peripheral Nervous System Diseases

Pain

Pain, Intractable

Neurologic Manifestations

Neuromuscular Diseases

Quality of Life

Chronic Graft Versus Host Disease

Patients treated with ozone as adjuvant palliative therapy. The procedure of ozone administration, dosage, frequency, and duration of ozone treatment will depend on the treated symptom and clinical evolution. Usually planned 40 sessions.

Systemic and/or local ozone administration. Dosage, frequency, and duration of ozone treatment will depend on the treated symptom and clinical evolution. Usually planned 40 sessions.

Ozone therapy

Bernardino Clavo, MD, PhyD

Francisco Rodríguez-Esparragón, BSci, PhyD

Francisco Rodríguez-Esparragón, BSc, PhyD

Miguel A Caramés-Álvarez, MD

Pedro G Serrano-Aguilar, MD, PhyD

The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms, who have been referred to the HUGCDN Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between June-2022 and December-2025

Chronic Pain Unit in the absence or failure of standard treatment, or when the standard treatment is associated with high morbidity or high risk. Frequently, these patients present alterations in self-perceived health-related quality of life (HRQoL), anxiety, depression, and other symptoms. This study aims to evaluate in these patients the effect of adjuvant symptomatic/palliative ozone therapy on the HRQoL and the potential changes from baseline on several parameters after treatment.

MAIN OBJECTIVES: To evaluate in these patients: 1) the clinical effect on the HRQOL of adding ozone to the standard treatment.

SECONDARY OBJECTIVES: To evaluate in these patients changes from baseline on 2) anxiety and depression, 3) pain (if applicable), 4) grade of toxicity (if applicable), 5) requirements of invasive procedures for symptom management, 6) evolution of main symptoms, 7) evolution of oxidative stress and inflammation (if systemic ozone therapy).

METHODOLOGY: Prospective and observational study of patients referred to our Chronic Pain Unit for symptomatic/palliative treatment with ozone therapy between 2022 and 2025.

MAIN VARIABLE: 1) HRQoL through the EQ-5D-5L questionnaire

SECONDARY VARIABLE: 2) anxiety and depression through the hospital anxiety/depression (HAD) questionnaire, 3) Pain through the visual analog scale (VAS), 4) grade of toxicity in cancer patients through the CTCAE v5.0 scale, 5) the number of invasive procedures required for symptom management, 6) self -reported percentage of symptom improvement, 7) biochemical parameters of oxidative stress and inflammation.

Assessments at weeks: 0 (baseline), 16 (end of O3/O2 treatment, objective), 28 (12 weeks after the end of ozone), and 40 (24 weeks after the end of ozone, control) Length of treatment: as required; initially, planned 16 weeks. Follow-up: 24 weeks after finishing O3/O2 treatment. Planned length of the clinical trial: 49 months.

Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025

Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025. (EPOOzo)

Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to...) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)

HAD scale is a self-administered questionnaire which assesses 14 items pertaining to symptoms of anxiety (seven) and depression (seven) experienced by patients. Each item is scored from 0 (better, no alteration) to 3 (worse level of alteration). For each symptom, overall score is from 0 (better, no anxiety or depression) to 21 (worse, very severe anxiety or depression).

Self-reported evaluation of the severity of pain according to the VAS, scored from 0 ("No pain") to 10 ("Pain as bad as you can imagine")

Grade of toxicity secondary to cancer-treatment according to the CTCAE v5.0 (Common Terminology Criteria for Adverse Events from the National Cancer Institute) scale. Each toxicity is usually scored from 0 (asymptomatic or mild symptoms) to 5 (death).

Number of invasive procedures (surgery, blood transfusions, and therapeutic endoscopic procedures) required for symptom management.

Self -reported percentage of symptom improvement from Baseline

Serum levels of biochemical parameters of oxidative stress

Serum levels of pro-inflammatory cytokines

Number of invasive procedures ((surgery, blood transfusions, and therapeutic endoscopic procedures) required for symptom management.

Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC)

Servicio Canario de Salud

Cabildo de Gran Canaria

Red de Investigación en Servicios de Salud en Enfermedades Crónicas

Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna

Bernardino Clavo, MD, PhD

MD, PhD, Head of Research Unit

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Behavioral Symptoms

Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive laughter therapy twice a week for an average of 40-60 minutes for 8 weeks.

Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive an average of 40-60 minutes of mindfulnes therapy twice a week for 8 weeks.

Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive standard hospital care only.

They will gather in five-person chemotherapy rooms, and laughter therapy will be applied to the women in the application group while they are receiving chemotherapy. Sessions will last approximately 40-60 minutes.The application will last for a total of 8 weeks, twice a week.

the laughter therapy group

Mindfulnes therapy will be applied to the women in the application group while they are receiving chemotherapy, in five-person chemotherapy rooms. Sessions will last approximately 40-60 minutes.The application will last for a total of 8 weeks, twice a week.

the mindfulness therapy group

Zehra Coktay, phd stu

Rukiye Turk Delibalta, assoc prof

zehra coktay, phd stu

zehra Coktay, phd stu

Breast cancer is defined as the most common type of cancer that causes death among women (Siegel et al. 2019). It constitutes 24% of cancers and 15% of cancer-related deaths in women (T.R. Ministry of Health 2020). According to statistics made towards the end of 2020, there are 7.8 million women in the world who were diagnosed with breast cancer in the last 5 years and are alive. It is estimated that one in every 8 women will develop breast cancer in developed countries (WHO 2021).

The Ministry of Health reported the frequency of breast cancer in our country as 45.6/100,000 in women in 2018. The incidence of breast cancer is reported to be higher, especially in the 45-54 age range (TC Ministry of Health 2020).

Chemotherapy is one of the most frequently preferred treatment methods in the treatment of breast cancer and can cause serious side effects such as pain, nausea and vomiting, loss of appetite, shortness of breath, mouth sores, fatigue, insomnia, anxiety and depression, and may lead to a deterioration in the quality of life of patients (Waks and Winer 2019, Samami et al. 2021, Sajadian et al. 2017, McFarland et al. 2018, Hamer et al. 2017).

In the international and national literature, no study has been found comparing the effects of laughter and mindfulness therapy on the anxiety, depression, quality of life and spiritual well-being experienced by breast cancer patients. In this study, it is planned to investigate the effects of laughter and mindfulness therapy applications on the anxiety, depression, quality of life and spiritual well-being levels of women with breast cancer receiving chemotherapy.

Since breast cancer is a type of cancer more common in women, only patients diagnosed with female breast cancer were included.

The Effect of Laughter and Mindfulness Therapy Applications on Women With Breast Cancer Receiving Chemotherapy: Randomized Controlled Study

The Effect of Laughter and Mindfulness Based Stress Reduction Applications on Anxiety, Depression, Quality of Life and Spiritual Well-Being Levels of Women With Breast Cancer Receiving Chemotherapy: Randomized Controlled Study

According to the scoring, 0-1 is considered as not sick, 2 is borderline sick, and 2-3 is considered seriously ill.

Higher scores on the functional scale indicate higher/healthier functions, and higher scores on the general health status/quality of life indicate higher quality of life. However, high scores on the symptom scale indicate a high rate of symptomatology/problems (Fayers et al. 2001).

Meaning sub-dimension (Items 2,3,5,8) has a total score of 0-16 points, Peace sub-dimension (Items 1,4,6,7) has a total score of 0-16 points, Belief sub-dimension (Items 9,10,11) ,12) total score ranges from 0-16 points, and the total score of the scale is 0-48 points. A higher scale score indicates better spiritual well-being.

Kafkas University

PhD Student

Fatigue

Cognitive Dysfunction

During the initial week of intervention, sessions will be mainly carried on horseback. We will use the movement of the horse: (i) to allow patient re-appropriating her body and find harmony; (ii) to initiate rehabilitation of movements (shoulder, neck, upper extremity, whole body), gesture and femininity. The goal is to reconstruct a harmonic body image both in the private and public sphere, through different techniques. A few walking sessions may be needed to reinforce some landmarks.

During the short stages the work will be mainly done by walking alongside the horse. These reinforcement periods act like a trampoline, necessary to have a new momentum providing the opportunity to take a step back from the everyday, to regenerate somehow. The reaction time is generally optimized considering the imprint done during the initial long stage. One of the main themes that come up during this period is fear (relapse, the future, not achieving the goals, pain, relationship issues, etc.).

Patients in the control group are followed by dedicated personnel of the Montpellier Institut du Sein. This personalized care pathway after/during the cancer treatment takes into consideration all aspects of the disease, allowing to coordinate the intervention of the professionals that the patient might need in order to better preserve her quality of life while answering questions about cancer, prevention, treatments, or life after illness. The MIS mobilizes a chain of skills and support by providing patients: radiologists, pathologists, surgeons, oncologists, and radiation therapists, nuclear doctors, physiotherapists, cardiologists, psychologists, psychiatrists, nurses, social workers, nutritionists, dieticians, onco-geneticists, osteopaths, homeopaths, acupuncturists, sexologists, addictologists, algologists, and vascular physicians.

The horse is an excellent collaborator in situations of physical and mental disability, whether temporary or consolidated. It provides support to humans towards an impairment (anatomical or physiological), a disability, or a restriction of participation as defined by the WHO in 2001. Hippotherapy has a direct action on the sensorimotor capacities of the individual but also on their cognitive capacities, such as attention, memory, psychomotricity, emotions, perceptions, the sequencing of complex movements, or the experience of oneself and the functions of time. Overall, the strong demand from the sensitive, sensory and motor spheres promotes and interacts with the mechanisms linked to the execution of tasks in the cognitive domain (memory, attention, executive functions, speed of information processing, etc.) through the interactions of several neural networks.

Hippotherapy

Personalized care pathway after/during the cancer treatment takes into consideration all aspects of the disease, allowing to coordinate the intervention of the professionals that the patient might need in order to better preserve her quality of life while answering questions about cancer, prevention, treatments, or life after illness. The MIS mobilizes a chain of skills and support by providing patients: radiologists, pathologists, surgeons, oncologists, and radiation therapists, nuclear doctors, physiotherapists, cardiologists, psychologists, psychiatrists, nurses, social workers, nutritionists, dieticians, onco-geneticists, osteopaths, homeopaths, acupuncturists, sexologists, addictologists, algologists, and vascular physicians.

Conventional therapy

Manuel Gaviria, MD, PhD

Breast cancer is the most common women's cancer and the third leading cause of death. Advances in prevention, detection and primary treatment have improved overall survival leading to its growing acceptance as a long-term disease. Following the announcement of breast cancer, but also after primary treatment, some symptoms appear directly compromising psychic and physical spheres. Hippotherapy is an emerging specialized rehabilitation approach performed through specially trained horses by accredited health professionals. The proposed hippotherapy program offers key elements for physical, psychic and social reinforcement, complementing conventional care. The aim is to provide patients with tools to consolidate their self-awareness and thus strengthen their ability to cope with the disease.

Following the announcement and evolution of breast cancer, but also in response to primary treatment, some symptoms appear to directly compromise the psychic and/or physical sphere of the individual. Current rehabilitation programs are not sufficiently oriented to solve most of these symptoms. Hippotherapy is an emerging specialized rehabilitation approach, performed on a specially trained horse by accredited health professionals (e.g. medical doctors, physical therapists, occupational therapists, psychomotricians, speech-language pathologists, clinical psychologists). The horse is an excellent collaborator in situations of physical and psychic disability, whether temporary or consolidated. It provides human support for impairments (anatomical or physiological), activity limitations, and participation restrictions as defined by WHO. Hippotherapy has a direct action on the sensorimotor capacities of the individual but also on his cognitive abilities, i.e. attention, memory, psychomotricity, emotion, perception, sequencing of complex movements, self-experience, psychic temporality. Overall, the strong solicitation of the sensory and motor spheres promotes and interacts with the mechanisms related to the execution of tasks in the cognitive domain through the interactions of several neural networks. A randomized simple-blinded controlled trial on hippotherapy versus conventional care will be carried out. After giving their informed consent, patients will be enrolled in the trial. The 6-months program includes 1-week daily sessions of hippotherapy by the end of the initial cancer treatment followed by three short 2-days sessions with an interval of 2 months between each. The study will focus on 86 patients. Recruitment will be done over a 48-months' period. A battery of self-administered questionnaires will allow to study both the functional and psychological outcome. The primary end point will be quality of life, whereas body image, fatigue, anxiety, depression and cognitive performances will be the secondary end points.

A randomized simple-blind controlled trial on efficacy of the hippotherapy treatment against conventional one will be conducted. Patients selected will be randomly divided into 2 groups: hippotherapy treated group versus control group. To ensure that patients in the 2 groups are similar in all respects, except for the planned intervention, the randomization will be stratified by age representing respectively two stages: 1) Pre-menopause; 2) Post-menopause; and by type of treatment: A) Single treatment: surgery or chemotherapy or hormone therapy or radiotherapy; B) Two or more treatments.

Data will be collected on the Montpellier Institut du Sein site by relying on the CRA who will follow up and check the information in due time of the self-questionnaires. The data will be duly anonymized and handled blindly. Data will be centralized on a secure server at the Equiphoria Institute. Their processing and analysis will be carried out blindly by the PI or by a private service provider (Biostatem France)

Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer

Effect of Multidisciplinary Management by Hippotherapy on the Quality of Life of Women With a Diagnosis of Breast Cancer: Randomized Controlled Clinical Trial on the Effectiveness of the Therapeutic Intervention

Dissemination of study results will be done through a classic strategy for publications (reports, scientific publications) and communications (congresses, meetings). The coordinator will be in charge of the dissemination strategy. Controlled access to the final trial dataset will be given when a reasonable request has a precise and valid scientific aim. Thus, we will protect the rights of patients and the intellectual property of the scientists who designed the trial and collected the data.

This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts. The scores ranges from 0 to 100, a higher score represents a higher ("better") level of functioning.

The questionnaire focuses on patients' emotional and behavioral experiences of their body image, resulting from cancer and treatment, including aspects of perceived physical appearance, body integrity, and seduction capacity. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.

MFI seems to be one of the best questionnaires to provide a fatigue profile. Its psychometric properties have been studied in different populations and it is easy to administer. Score ranges from 0 to 100. Higher total scores correspond with more acute levels of fatigue.

This scale was constructed excluding any item concerning somatic aspects, aspects that could be confused between physical and mental illness. It is a self-questionnaire to be completed according to oneself condition during the past week. Score ranges from 0 to 21 for each item. Higher total scores correspond to presence of the respective state.

The questions are grouped into six cognitive domains (memory, verbal fluency, concentration, mental sharpness, resistance to interference, multitasking ability) and two sub-criteria (visibility of the disorder by the entourage, impact on the quality of life). 37-item ranging from 0 to 4 consist of four subscales. Higher scores represent better functioning.

Institut Equiphoria - La Canourgue, France

Montpellier Institut du Sein - Montpellier, France

Clinique Clementville - Montpellier, France

Klésia Languedoc Service de l'Action Sociale - France

Fondation Crédit Agricole Solidarité et Développement - France

Crédit Agricole du Languedoc - France

Alliance Equiphoria

Neuralgia

This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale

Magnesium: Magnésium UPSA Action Continue®

Placebo: Lactose

Patrick LACARIN

Dominique JOLY

Christine VILLATTE

Christophe POMEL

Pierre GIMBERGUES

Xavier DURANDO

Claude DUBRAY

Gisèle PICKERING

In breast cancer patients undergoing a mastectomy, the aim of this study is to evaluate if the magnesium administered for 6 weeks starting two weeks before the surgery induces a decrease of pain intensity one month post-mastectomy compared to the placebo group.

This is a randomized, placebo-controlled double-blind clinical trial conducted in the Oncology Hospital, Clermont-Ferrand, France, in 100 patients suffering from breast cancer and undergoing a total mastectomy.

This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.

Pain and Magnesium

Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain

Measure of average pain intensity by a numerical rating scale assessed 5 days before the visit at 1 month post-mastectomy in magnesium and placebo groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025	NCT05417737	Radiation Toxic... Chemotherapeuti... Chemotherapy-in... Delayed Wound H... Chronic Pain Refractory Pain	Ozone therapy	18 Years -	Dr. Negrin University Hospital
The Effect of Laughter and Mindfulness Therapy Applications on Women With Breast Cancer Receiving Chemotherapy: Randomized Controlled Study	NCT06116812	Breast Cancer Laughter Therap... Mindfulness The... Life Quality Anxiety and Dep... Spiritual Well-...	the laughter th... the mindfulness...	18 Years - 60 Years	Kafkas University
Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer	NCT04350398	Breast Cancer F... Side Effects Psychological D... Physical Disabi...	Hippotherapy Conventional th...	18 Years - 80 Years	Alliance Equiphoria
Pain and Magnesium	NCT03063931	Neuropathic Pai...	Magnesium: Magn... Placebo: Lactos...	18 Years -	University Hospital, Clermont-Ferrand

Spots Global Cancer Trial Database for anxiety and depression