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:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT00152867
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with breast cancer who will receive their first cycle of non-cisplatin moderately emetogenic chemotherapy. The following regimens can be administered:
* 14-day regimens dose dense
* 21-day regimens:
* Adriamycin and Cyclophosphamide (AC) + a Taxane (T) Other regimens are eligible as long as no cisplatin or other highly emetogenic agent is part of the regimen, and a moderately emetogenic agent is included.
* Aged \> 18 years
* Performance status of 0-2 on the European Cooperative Oncology Group (ECOG) performance scale
* Full recovery from any post operative sequelae
* Patients on opioids are eligible as long as their doses are stable (no change to dose in the previous week) and they have no nausea or vomiting in the 24 hours prior to the study
* Informed signed consent
Exclusion Criteria:
* Patient has previously received chemotherapy
* Patient has received or will receive radiation therapy to the abdomen or pelvis in the week prior to treatment
* Nausea or vomiting in the 24 hour period prior to commencing chemotherapy
* Use of antiemetics within 24 hours of the study period
* Patient has an active infection (e.g. pneumonia) or any uncontrolled disease (e.g. diabetes, gastrointestinal obstruction), which in the opinion of the investigator might confound the results of the study or pose unwarranted risk. Patients with controlled diabetes are eligible.
* Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
* Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that in the opinion of the investigator precludes study entry.
* Patient has a history of hypersensitivity or contraindication to granisetron or dexamethasone.
* Patient is taking any systemic corticosteroid therapy at any dose. Topical or inhaled steroids are permitted.
* Use of benzodiazepines in the 48 hours prior to the study period with the exception of a single dose if used for sleeping.
* Abnormal laboratory values:
* Absolute neutrophil count \< 1.5 X 10\^9/L
* Platelet count \< 100 X 10\^9/L
* Liver transaminases \> 2.5 X upper limit of normal
* Bilirubin \> 1.5 X upper limit of normal
* Creatinine \> 1.5 X upper limit of normal
* Patients who will receive a different chemotherapy regimen in Cycle 2 than in Cycle 1. Changes in the dose of the same chemotherapy agents are permitted if required for toxicity.
* Refusal to give informed consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00152867
Study Brief:
Protocol Section:
NCT00152867