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The objective of this study was to evaluate the various parameters involved in the occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Nausea and Vomiting | acute nausea and vomiting and/or delayed measured by the tool of anti emetic MAT MASCC. Such self-administered questionnaire was found to be sensitive to detect the different dimensions of chemo-induced nausea and vomiting and to perform well against a daily assessment of nausea and vomiting. The MAT questionnaire separately asks for acute (within 24h of initial administration of chemotherapy) and delayed (from 24h to 4 days after chemotherapy) chemo-induced nausea and vomiting by asking the patient to fill out the first page the day after chemotherapy referring to the first 24h following chemotherapy and the second page 4 days after chemotherapy concerning the period from the day after to 4 days after chemotherapy. Clinically significant nausea was defined by reported nausea intensity >=3 on a 0-10 scale, 10 being the highest intensity of nausea. Clinically significant chemo induced nausea/vomiting was defined by greater than or equal to one nausea episode/vomiting, respectively. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
This does not concern patients who:
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Patients treated with first line chemotherapy with intravenous (IV) to solid tumors or hematologic.
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| Name | Affiliation | Role |
|---|---|---|
| JOLY Florence, Pr | Centre François Baclesse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de la Baie | Avranches | 50307 | France | |||
| Centre hospitalier |
Eligible patients were older than 18 years, chemotherapy naive, and with a histologically proven solid malignant tumour requiring chemotherapy whatever the stage of the disease.
Patients had to understand the procedures and agree to participate in the study by giving written informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental arm | Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm | Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Acute Nausea and Vomiting | acute nausea and vomiting and/or delayed measured by the tool of anti emetic MAT MASCC. Such self-administered questionnaire was found to be sensitive to detect the different dimensions of chemo-induced nausea and vomiting and to perform well against a daily assessment of nausea and vomiting. The MAT questionnaire separately asks for acute (within 24h of initial administration of chemotherapy) and delayed (from 24h to 4 days after chemotherapy) chemo-induced nausea and vomiting by asking the patient to fill out the first page the day after chemotherapy referring to the first 24h following chemotherapy and the second page 4 days after chemotherapy concerning the period from the day after to 4 days after chemotherapy. Clinically significant nausea was defined by reported nausea intensity >=3 on a 0-10 scale, 10 being the highest intensity of nausea. Clinically significant chemo induced nausea/vomiting was defined by greater than or equal to one nausea episode/vomiting, respectively. | Data from MAT to measure chemotherapy-induced nausea and vomiting were available for 248 patients of the 291 included (85.2%). | Posted | Count of Participants | Participants | 24 hours |
From enrollment until end of follow-up, up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental arm | Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra LECONTE | Centre François Baclesse | 0231455002 | a.leconte@baclesse.unicancer.fr |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Bayeux |
| 14400 |
| France |
| Centre Maurice Tubiana | Caen | 14052 | France |
| Centre François Baclesse | Caen | 14076 | France |
| Centre hospitalier public du cotentin | Cherbourg-Octeville | 50100 | France |
| Centre Jacques Monod | Flers | 61104 | France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Stage of the disease | Participants were categorized according to the clinical treatment setting at the time of inclusion, which reflects disease severity and treatment intent. Three clinical categories were defined: Adjuvant setting: patients with resected disease receiving postoperative systemic therapy with curative intent. Neoadjuvant setting: patients receiving systemic therapy prior to planned tumor resection with curative intent. Metastatic setting: patients with unresectable or metastatic disease receiving systemic therapy with palliative intent. | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|
| OG000 | Experimental arm | Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting. |
|
|
| 1 |
| 291 |
| 1 |
| 291 |
| 260 |
| 291 |
| ABDOMINAL PAIN | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| ASCITES | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| PLEURAL EFFUSION | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Systematic Assessment |
|
| HEPATIC CYTOLYSIS | HEPATOBILIARY DISORDERS | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
|
| MALAISE | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| MYALGIA | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
|
| VOMITING | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| BRONCHITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| HEADACHE | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
|
| INSOMNIA | PSYCHIATRIC DISORDERS | Systematic Assessment |
|
| APLASIA | CONGENITAL, FAMILIAL AND GENETIC DISORDERS | Systematic Assessment |
|
| PYELONEPHRITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| ANGINA PECTORIS | CARDIAC DISORDERS | Systematic Assessment |
|
| ESCHERICHIA INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| PYREXIA | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| RASH | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | Systematic Assessment |
|
| FUNGAL INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| FOLLICULITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| ALOPECIA | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
|
| ASTHENIA | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| DECREASED APPETITE | METABOLISM AND NUTRITION DISORDERS | Systematic Assessment |
|
| VAGINAL INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| FEBRILE BONE MARROW APLASIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
|
| VISUAL IMPAIRMENT | EYE DISORDERS | Systematic Assessment |
|
| MIGRAINE | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
|
| HERPES ZOSTER | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| BONE PAIN | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
|
| TREMOR | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
|
| THROMBOCYTOPENIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
|
| NEUTROPENIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
|
| SCIATICA | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
|
| TOOTH ABSCESS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| CONSTIPATION | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| DRY SKIN | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | Systematic Assessment |
|
| SINUSITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| ACUTE KIDNEY INJURY | RENAL AND URINARY DISORDERS | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
|
| ANAEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
|
| PARAESTHESIA | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
|
| DIARRHOEA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| NASOPHARYNGITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| NECK PAIN | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
|
| HYPERSENSITIVITY | IMMUNE SYSTEM DISORDERS | Systematic Assessment |
|
| APHTHOUS ULCER | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| PALPITATIONS | CARDIAC DISORDERS | Systematic Assessment |
|
| PHARYNGITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| ARTHRALGIA | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| TOOTHACHE | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| ANXIETY | PSYCHIATRIC DISORDERS | Systematic Assessment |
|
| INTESTINAL ISCHAEMIA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| PAIN | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| BACK PAIN | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
|
| ORAL CANDIDIASIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| PRURITUS | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | Systematic Assessment |
|
| DENTAL CARE | SURGICAL AND MEDICAL PROCEDURES | Systematic Assessment |
|
| HOT FLUSH | VASCULAR DISORDERS | Systematic Assessment |
|
| DYSPHAGIA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | INVESTIGATIONS | Systematic Assessment |
|
| HYPERTHERMIA | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| HYPOTENSION | VASCULAR DISORDERS | Systematic Assessment |
|
| URINARY TRACT INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| DYSAESTHESIA | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
|
| COUGH | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Systematic Assessment |
|
| GASTROENTERITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| HAEMORRHOIDS | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| EPISTAXIS | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | Systematic Assessment |
|
| CANDIDIASIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| LARYNGITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| FATIGUE | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| TOOTH INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| TACHYCARDIA | CARDIAC DISORDERS | Systematic Assessment |
|
| OROPHARYNGEAL CANDIDIASIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| VULVOVAGINAL MYCOTIC INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
|
| MUSCLE SPASMS | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
|
| ODYNOPHAGIA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
|
| WEIGHT DECREASED | INVESTIGATIONS | Systematic Assessment |
|
| DYSGEUSIA | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
|
| CHILLS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
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