Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Blinatumomab

On the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day.

Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group.

Blinatumomab will be bridged to conventional BUCY conditioning regimen.

Control group will be given conventional BUCY conditioning regimen.

Conventional therapy

Huizhu Kang, MD

Meng Zhou, MD

Xiang Zhang, PhD

Yue Han, MD/PhD

To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia

High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.

Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL

A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia

The time from randomization to death from any cause.

Negative MRD is defined as below 10-4 by flow cytometry.

It is defined as the total survival of a patient after the hematopoietic stem cell transplantation, until the tumor recurrence or death from any cause.

From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event.

Fujian Medical University Union Hospital

Zhongda Hospital

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The First People's Hospital of Changzhou

Wuxi People's Hospital

First Affiliated Hospital of Wannan Medical College

The First Affiliated Hospital of Soochow University

Director

Infections

Digestive System Diseases

Symptoms and General Pathology

Hepatitis A

Hepatitis

Hepatitis B

Liver Neoplasms

Virus Diseases

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Communicable Diseases

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Gastrointestinal Neoplasms

Digestive System Neoplasms

Primary Liver Cancer

Herpes Simiae (B Virus)

Hematinics

Anti-Infective Agents

Liver Extracts

Antiviral Agents

Entecavir

100 HCC patients will be allocated to receive anti-virus therapy.

100 patients will undergo conventional therapy

conventional therapy including protecting the liver function, anti-tumor and so on

conventional therapy

Shen Feng, M.D

This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.

primary liver cancer(PLC)is one of the world's most common malignancies, especially in East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC cases in China. PLC can develop during any stage of the natural course of chronic HBV infection and anti-virus therapy should be considered during the management of PLC. However, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable PLC. Because of these facts, research on the significant of the anti-virus therapy in the HBV-related PLC is urgently needed.

200 patients will be randomly assigned to anti-virus therapy group and control gruop.The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on PLC.

The aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus therapy in PLC.

Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer

A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-virus Therapy for the Unresectable Hepatitis B Virus-related Primary Liver Cancer

Eastern Hepatobiliary Surgery Hospital

vice president of the Eastern Hepatobiliary Surgery Hospotal

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Colonic Diseases

Other Dietary Supplements

Herbal and Botanical

Acidophilus

Bifidobacterium

Cola

CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type).

citogenex

conventional therapy for colon-rectal cancer

Giovanni Tomasello, MD

Francesco Cappello, MD

Provvidenza Damiani, MD

Manfredi Rizzo, MD

The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.

CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). These subspecies of probiotics bacteria have been shown to be effective in improving the immunity. Several trials are currently underway, in order to evaluate the effects of probiotics as potential novel therapies in addition to traditional therapeutic approaches. Although probiotics do not play an anti-tumor action per se, these agents may significantly contribute to decrease the typical side effects due to traditional anti-tumor treatments, such as gastrointestinal symptoms, immunity deficit, as well as the alterations in the gut lymphoid tissue.

It is therefore expected that CITOGENEX may have several significant beneficial effects in patients under anti-tumor treatments. In order to test this hypothesis, we will perform a randomized, single-blind, two-arms, prospective study in patients with colon-rectal cancer.

Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

University of Palermo

Assistant Professor

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Anxiety Disorders

Depressive Disorder

Fatigue

Breast Neoplasms

Depression

Cognitive Dysfunction

Breast Diseases

Skin Diseases

Quality of Life

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL	NCT05559450	B-cell Acute Ly...	Blinatumomab Conventional th...	14 Years - 65 Years	The First Affiliated Hospital of Soochow University
Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL	NCT05559450	B-cell Acute Ly...	Blinatumomab Conventional th...	14 Years - 65 Years	The First Affiliated Hospital of Soochow University
Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer	NCT00824707	Primary Liver C...	Entecavir conventional th...	18 Years - 70 Years	Eastern Hepatobiliary Surgery Hospital
Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL	NCT05559450	B-cell Acute Ly...	Blinatumomab Conventional th...	14 Years - 65 Years	The First Affiliated Hospital of Soochow University
Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer	NCT01477866	Colonic Neoplas...	citogenex conventional th...	40 Years - 60 Years	University of Palermo
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

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