Symptoms and General Pathology

Wounds and Injuries

All Conditions

Blood and Lymph Conditions

Behaviors and Mental Disorders

Rare Diseases

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Body Temperature Changes

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Stress Disorders, Traumatic

Heat Stress Disorders

Granulocytopenia

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Anti-Bacterial Agents

Amoxicillin

Tazobactam

Piperacillin

Clavulanic Acid

Piperacillin, Tazobactam Drug Combination

Amoxicillin-Potassium Clavulanate Combination

Levofloxacin

Ofloxacin

Penicillins

Antibiotics, Antitubercular

Clavulanic Acids

Antibiotic treatment stopped after 72h, regardless of fever.The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively.

Antibiotic treatment continued according to accepted guidelines and current clinical practice. The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively.

Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever

Early antibiotic discontinuation

Continued antibiotic treatment as accepted by guidelines for febrile neutropenia

Usual practice

Mical Paul, MD

Leonard Leibovici, Prof

Dafna Yahav, MD

The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.

Febrile neutropenia remains a major cause of morbidity in solid cancer patients. There is an unresolved question regarding the appropriate duration of antibiotic treatment for patients with febrile neutropenia of unknown origin. Current guidelines recommend at least seven days of antibiotic treatment. Several studies have demonstrated the safety of early antibiotic discontinuation in patients with febrile neutropenia. We plan an open label randomized controlled trial to compare early antibiotic discontinuation to the accepted prolonged antibiotic treatment protocol

Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia

Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial

Composite outcome of all-cause mortality, severe infection (defined as clinically or microbiologically documented infection with systemic inflammatory response syndrome (SIRS)), severe diarrhea (\>=3 daily for \>=2 days) or fever (\>38)

Total febrile or antibiotic days from the day of randomization until day 30, defined as a day with one or more temperature measurement \>38.0°C or a day on which antibiotic treatment was prescribed for any reason other than prophylaxis

Clinically and/or microbiologically documented infections within 30 days of randomization. We will use the 2008 CDC/NHSN surveillance definitions of health-care associated infections for bacterial infections (including Clostridium difficile) and the 2008 revised definitions for invasive fungal infections.

Total in-hospital days from the day of randomization up to day 30

Rates of re-admission for any reason other than planned chemotherapy.

Patients receiving antibiotic treatment after day 7 from randomization until day 30

Duration of intravenous antibiotic treatment

Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.

Cause of death adjudicated by the trial's safety committee

Rabin Medical Center

Professor

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast cancer conservative surgery will be performed by removing the tumor according to the usual technique and then the defect generated will be filled with a silicone prosthesis of the same size. Said prosthesis will be covered with fat and subcutaneous cellular tissue and then the skin will be closed.

Breast cancer conservative surgery will be performed according to the usual surgical technique, that is, removing the tumor and covering the defect by mobilizing the breast tissue and then closing the skin.

Silicone prosthesis

The placement of a small silicone prosthesis in the partial defects generated by conservative breast cancer surgery improves the aesthetic result, compared to the usual surgical technique, in a safe and reproducible way and compatible with adjuvant treatments. It could also potentially improve the quality of life of patients

Conservative surgery in breast cancer is performed more than 50% of cases, however, aesthetic results are suboptimal, because reconstructive techniques are performed in less than 5% of them. Objective: To demonstrate that the placement of a silicone prosthesis in partial defects generated by breast cancer conservative surgery improves the aesthetic result, compared to the usual surgical technique, safely, reproducibly and compatible with adjuvant treatments.

Methodology: Prospective randomized clinical trial, controlled with blind evaluator. Inclusion criteria: Women with breast cancer candidates for conservative surgery. Intervention: In the cases the study technique will be carried out consisting in the filling of the defect with a silicone prosthesis of size adjusted to it (2-4cm). Controls: usual surgical procedure. Main result variable: aesthetic results (visual analog scale) according to the patient, surgeon and blind external evaluator. Secondary variables: surgical complications, local complications derived from adjuvant treatments, rate of local recurrence, rate of reintervention due to affected margins, behavior in mammographic follow-up, professional satisfaction and impact on quality of life.

Group whith silicone prothesis Group whith standard surgical procedure

Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer

Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer: Randomized Clinical Trial

Aesthetic result of the new technique by applying a visual analog scale for measuring patient satisfaction.

Scale ranges: minimum score: 0 (no satisfaction - worse outcome), maximum score: 10 (total satisfaction - better outcome)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Immune System Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Patient will be follow only like usual practice

Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.

Only for arm AMA, patient will have one phone every week to evaluate physical conditions.

Telephone Intervention

Usual Practice

Loïc YSEBAERT, MD

The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.

Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy

Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy

Reductions in Relative Dose Intensity, calculated as the difference between initially planned doses of F, C and R and effectively prescribed doses of the 3 drugs, before and after 6 courses of FCR.

rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia	NCT01450241	Febrile Neutrop...	Early antibioti... Usual practice	18 Years -	Rabin Medical Center
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia	NCT01450241	Febrile Neutrop...	Early antibioti... Usual practice	18 Years -	Rabin Medical Center
Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer	NCT04092842	Breast Conservi...	Silicone prosth... Usual practice	18 Years -	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy	NCT01393366	Chronic Lymphoc...	Telephone Inter... Usual Practice	18 Years -	University Hospital, Toulouse
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy	NCT01393366	Chronic Lymphoc...	Telephone Inter... Usual Practice	18 Years -	University Hospital, Toulouse

Spots Global Cancer Trial Database for usual practice