Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT01857232
Eligibility Criteria:
Inclusion criteria
* Male or female patients ≥ 18 years of age
* Ability and willingness to give written informed consent
* Patients scheduled to receive, on day 1 of their chemotherapy, either: (i) a first cisplatin chemotherapy infusion at a dose of ≥70 mg/m2 (males and females); or (ii) a first infusion of cyclophosphamide at a dose of 500-1500 mg/m2 in combination with either epirubicin at a dose of 60-100 mg/m2 or doxorubicin at a dose of 40-60 mg/m2 (females only)
* Karnofsky performance score ≥ 60%
* Adequate cardiac, hepatic and renal function
* QTc interval \< 500 ms
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \< 5 x upper limit normal (ULN)
* Bilirubin \< 5 x ULN
* Creatinine \< 3 x ULN
* Adequate haematological function
* Haemoglobin ≥ 8 g/dL
* White blood count ≥ 3.0 x 109/L
* Platelet count ≥ 100 x 109/L
* For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards
Exclusion Criteria
* Patients scheduled to receive, prior to or in the 120 hours after cisplatin or AC, any other chemotherapeutic agent with a high or moderate emetic risk
* Patients who have previously received anti-neoplastic chemotherapy
* Patients scheduled to receive paclitaxel or docetaxel during the first cycle of their chemotherapy
* Patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours after cisplatin or AC administration
* Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or confirmed prolactin-dependent breast cancer) or phaeochromocytoma
* Patients with a pre-existing vestibular disorder
* Patients being treated with regular anti-emetic therapy including corticosteroids
* Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01857232
Study Brief:
Protocol Section:
NCT01857232