Trial Outcomes & Findings for Management of Nausea and Vomiting Chemotherapy-induced in Normandy (NCT NCT01440465)
NCT ID: NCT01440465
Last Updated: 2025-12-17
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
300 participants
Primary outcome timeframe
24 hours
Results posted on
2025-12-17
Participant Flow
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.
Participant milestones
| Measure |
Experimental arm
Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting.
|
|---|---|
|
Overall Study
STARTED
|
300
|
|
Overall Study
COMPLETED
|
291
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=291 Participants
Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting.
|
|---|---|
|
Age, Continuous
|
57 years
n=291 Participants
|
|
Sex: Female, Male
Female
|
248 Participants
n=291 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=291 Participants
|
|
Stage of the disease
Adjuvant setting
|
219 Participants
n=291 Participants
|
|
Stage of the disease
Neo-adjuvant setting
|
27 Participants
n=291 Participants
|
|
Stage of the disease
Metastatic setting
|
45 Participants
n=291 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Data from MAT to measure chemotherapy-induced nausea and vomiting were available for 248 patients of the 291 included (85.2%).
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.
Outcome measures
| Measure |
Experimental arm
n=248 Participants
Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting.
|
|---|---|
|
Number of Participants With Acute Nausea and Vomiting
|
101 Participants
|
Adverse Events
Experimental arm
Serious events: 1 serious events
Other events: 260 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental arm
n=291 participants at risk
Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting.
|
|---|---|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
Other adverse events
| Measure |
Experimental arm
n=291 participants at risk
Chemotherapy-naïve patients are included during the first cycle of treatment to assess frequency and intensity of chemotherapy-induced nausea and vomiting.
|
|---|---|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
53.6%
156/291 • Number of events 211 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
1.0%
3/291 • Number of events 4 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
ASCITES
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
HEPATOBILIARY DISORDERS
HEPATIC CYTOLYSIS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUCOSAL INFLAMMATION
|
5.5%
16/291 • Number of events 16 • From enrollment until end of follow-up, up to 6 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE NEUTROPENIA
|
4.1%
12/291 • Number of events 12 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MALAISE
|
1.0%
3/291 • Number of events 3 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN UPPER
|
2.4%
7/291 • Number of events 7 • From enrollment until end of follow-up, up to 6 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MYALGIA
|
1.4%
4/291 • Number of events 4 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
9.6%
28/291 • Number of events 34 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
BRONCHITIS
|
1.0%
3/291 • Number of events 3 • From enrollment until end of follow-up, up to 6 months
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
5.5%
16/291 • Number of events 17 • From enrollment until end of follow-up, up to 6 months
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
1.0%
3/291 • Number of events 3 • From enrollment until end of follow-up, up to 6 months
|
|
CONGENITAL, FAMILIAL AND GENETIC DISORDERS
APLASIA
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
PYELONEPHRITIS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
CARDIAC DISORDERS
ANGINA PECTORIS
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
ESCHERICHIA INFECTION
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
4.5%
13/291 • Number of events 13 • From enrollment until end of follow-up, up to 6 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
FUNGAL INFECTION
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
FOLLICULITIS
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ALOPECIA
|
15.1%
44/291 • Number of events 44 • From enrollment until end of follow-up, up to 6 months
|
|
NERVOUS SYSTEM DISORDERS
NEUROPATHY PERIPHERAL
|
4.8%
14/291 • Number of events 14 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
12.4%
36/291 • Number of events 36 • From enrollment until end of follow-up, up to 6 months
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
1.4%
4/291 • Number of events 4 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
VAGINAL INFECTION
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE BONE MARROW APLASIA
|
1.0%
3/291 • Number of events 3 • From enrollment until end of follow-up, up to 6 months
|
|
EYE DISORDERS
VISUAL IMPAIRMENT
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
NERVOUS SYSTEM DISORDERS
MIGRAINE
|
2.4%
7/291 • Number of events 7 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
HERPES ZOSTER
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BONE PAIN
|
1.4%
4/291 • Number of events 4 • From enrollment until end of follow-up, up to 6 months
|
|
NERVOUS SYSTEM DISORDERS
TREMOR
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
|
5.5%
16/291 • Number of events 19 • From enrollment until end of follow-up, up to 6 months
|
|
NERVOUS SYSTEM DISORDERS
SCIATICA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
TOOTH ABSCESS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
1.0%
3/291 • Number of events 3 • From enrollment until end of follow-up, up to 6 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DRY SKIN
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
SINUSITIS
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL CHEST PAIN
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
3.1%
9/291 • Number of events 9 • From enrollment until end of follow-up, up to 6 months
|
|
NERVOUS SYSTEM DISORDERS
PARAESTHESIA
|
1.4%
4/291 • Number of events 4 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
4.5%
13/291 • Number of events 13 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
NASOPHARYNGITIS
|
1.4%
4/291 • Number of events 4 • From enrollment until end of follow-up, up to 6 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
NECK PAIN
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
IMMUNE SYSTEM DISORDERS
HYPERSENSITIVITY
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
APHTHOUS ULCER
|
1.0%
3/291 • Number of events 3 • From enrollment until end of follow-up, up to 6 months
|
|
CARDIAC DISORDERS
PALPITATIONS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
PHARYNGITIS
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
TOOTHACHE
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
PSYCHIATRIC DISORDERS
ANXIETY
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
INTESTINAL ISCHAEMIA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
1.4%
4/291 • Number of events 4 • From enrollment until end of follow-up, up to 6 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
1.0%
3/291 • Number of events 3 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
ORAL CANDIDIASIS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PRURITUS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
SURGICAL AND MEDICAL PROCEDURES
DENTAL CARE
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
VASCULAR DISORDERS
HOT FLUSH
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
DYSPHAGIA
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
INVESTIGATIONS
BLOOD GLUCOSE INCREASED
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
HYPERTHERMIA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
VASCULAR DISORDERS
HYPOTENSION
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
NERVOUS SYSTEM DISORDERS
DYSAESTHESIA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
GASTROENTERITIS
|
0.69%
2/291 • Number of events 2 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
HAEMORRHOIDS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
EPISTAXIS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
CANDIDIASIS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
LARYNGITIS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
1.0%
3/291 • Number of events 3 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
TOOTH INFECTION
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
CARDIAC DISORDERS
TACHYCARDIA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
OROPHARYNGEAL CANDIDIASIS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
INFECTIONS AND INFESTATIONS
VULVOVAGINAL MYCOTIC INFECTION
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCLE SPASMS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GASTROINTESTINAL DISORDERS
ODYNOPHAGIA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
INVESTIGATIONS
WEIGHT DECREASED
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHILLS
|
0.34%
1/291 • Number of events 1 • From enrollment until end of follow-up, up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place