| Study characteristics |
| Methods |
Randomised, comparative, interventional, parallel, phase 3 trial with 2 arms
Recruitment period: 2012 to 2015
Masking: double‐blind
Baseline patient characteristics: n.r.
Follow‐up: n.r. |
| Participants |
Inclusion criteria
≥ 20 years old and ≤ 75 years old (at the time informed consent was obtained) female primary breast cancer stages I to III and scheduled to receive AC therapy ECOG performance status 0 to 1 Can correctly fill in a symptom diary meet the following standard values in general clinical tests: white blood cells ≥ 3000/mm³, neutrophils ≥ 1500/mm³, blood platelet count ≥ 100,000/mm³, AST (GOT) and ALT (GPT) ≤ 2.5 times high end of normal range at the facility, total bilirubin ≤ 1.5 times high end of normal range at the facility, creatinine ≤ 1.5 times high end of normal range at the facility normal cardiac function: ECG within normal range; no symptoms; no abnormality requiring treatment; cardiac function determined to be normal by Interview, echocardiography, chest X‐ray, BNP, etc.
Exclusion criteria
history of administration of moderately to highly emetogenic chemotherapy receiving an antiemetic drug (5‐HT₃ receptor antagonist, phenothiazine, butyrophenone, benzamide, dopamine receptor antagonist) received a benzodiazepine or a narcotic formulation within 48 h before commencement of AC therapy received systemic corticosteroid therapy within 72 h before commencement of AC therapy history of gastrointestinal tract surgery (excluding appendectomy) received or scheduled to receive radiation therapy for abdominal region (diaphragm or lower) or pelvis for a period from 6 days before commencement of AC therapy until Day 6 of AC therapy had vomiting or dry vomiting within 24 h before commencement of AC therapy active multiple cancer (synchronous multiple cancer or metachronous multiple cancer with disease‐free interval ≤ 5 years) symptomatic cerebral tumour (including a benign tumour) received the following drugs within 7 days before commencement of AC therapy: clarithromycin, erythromycin, ketoconazole, itraconazole, and digoxin received the following drugs within 4 weeks before commencement of AC therapy: barbiturate drug, rifampicin, phenytoin, and carbamazepine pregnant or lactating patients, patients who may be pregnant, patients hoping to become pregnant during the study period, and patients taking an oral contraceptive with coexisting disease, such as systemic infection, hepatitis, and uncontrollable diabetes, for whom dexamethasone sodium phosphate cannot be administered history of hypersensitivity to granisetron, palonosetron, aprepitant, or dexamethasone judged by investigator to be inappropriate for inclusion in the study
Mean/median age (range), years: n.r.
Gender: female
Tumour/cancer type: breast cancer
Chemotherapy regimen: anthracycline and cyclophosphamide‐containing regimens (AC)
Country: Japan (11 institutions) |
| Interventions |
Experimental: arm A: palonosetron
Day 1: aprepitant (125 mg) + palonosetron (0.75 mg) + dexamethasone (9.9 mg)
Days 2 to 3: aprepitant (80 mg)
Experimental: arm B: granisetron
Day 1: aprepitant (125 mg) + granisetron (40 μg/kg) + dexamethasone (9.9 mg)
Days 2 to 3: aprepitant (80 mg) |
| Outcomes |
Primary outcome
Secondary outcomes
proportion of patients who showed complete response (no vomiting and no salvage treatment) from 0 to 24 hours of AC therapy proportion of patients who showed complete response (no vomiting and no salvage treatment) from 0 to 120 hours of AC therapy proportion of patients who showed no nausea/degree of nausea quality of life dietary intake adverse events
|
| Notes |
registration ID: UMIN000007882 funding source: non‐profit organisation: Japan Clinical Research Support Unit conference abstract, results are still unpublished |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Comment: randomised trial but method of randomisation not described |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: allocation concealment not reported |
| Blinding of participants and personnel (performance bias)
Blinding of participants |
Low risk |
Quote: "... double‐blind ..." |
| Blinding of participants and personnel (performance bias)
Blinding of personnel |
Low risk |
Quote: "... double‐blind ..." |
| Blinding of outcome assessment (detection bias)
Subjective outcomes (Patient reported outcomes) |
Low risk |
Comment: both patients and personnel were blinded towards the intervention and thus had no influence on outcome assessment |
| Incomplete outcome data (attrition bias)
Subjective outcomes (Patient reported outcomes) |
Low risk |
Comment: all patients were included for patient‐reported outcomes analysis |
| Selective reporting (reporting bias) |
High risk |
Comment: only complete response and quality of life were reported in the results section |
| Other bias |
Unclear risk |
Comment: conference abstract, not evaluable |
