Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer

Browse trials for

• Breast Neoplasms 12,544
• Breast Neoplasms, Male 118
• Nausea 822
• Vomiting 1,100

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 41 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Study arms

• Active comparator
  Dexamethasone + Ondansetron IV on Day 1

  All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).

  Drug: cyclophosphamide · Drug: dexamethasone · Drug: doxorubicin hydrochloride · Procedure: quality-of-life assessment · Procedure: nausea and vomiting therapy · Procedure: management of therapy complications · Drug: ondansetron hydrochloride · Other: survey administration

• Experimental
  Dexamethasone + Palonosetron IV on Day 1

  All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).

  Drug: palonosetron hydrochloride · Drug: cyclophosphamide · Drug: dexamethasone · Drug: doxorubicin hydrochloride · Procedure: quality-of-life assessment · Procedure: nausea and vomiting therapy · Procedure: management of therapy complications · Other: survey administration

Interventions

• Drugpalonosetron hydrochloride

  Given IV

  Also known as: Aloxi, RS 25259-197

• Drugcyclophosphamide

  Given orally

  Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

• Drugdexamethasone

  Given orally or IV

  Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

• Drugdoxorubicin hydrochloride

  Given IV

  Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF

• Procedurequality-of-life assessment

  Ancillary studies

  Also known as: quality of life assessment

• Procedurenausea and vomiting therapy

  Given IV

  Also known as: antiemetic support, management of nausea and vomiting, nausea and vomiting management, therapy, nausea and vomiting, vomiting and nausea management

• Proceduremanagement of therapy complications

  Given IV

  Also known as: complications of therapy, management of

• Drugondansetron hydrochloride

  Given IV

  Also known as: GR 38032F, GR-C507/75, SN-307, Zofran

• Othersurvey administration

  Ancillary studies

Primary outcomes

1. Count of Patients Achieving a Complete Response

   Time frame: At 0-24 hours after weekly intravenous doxorubin

Secondary outcomes

1. Count of Patients Achieving Complete Response

   Time frame: At 24-120 hours after weekly intravenous doxorubicin

2. Number of Days With Emetic Episodes and Rescue Medicines

   Time frame: Up to 3 months

3. Number of Participants That Had Emesis Within 48 Hours of Chemotherapy

   Count of patients that had emesis within 48 hours of chemotherapy

   Time frame: Up to 48 hours of chemotherapy

4. Number of Participants That Had First Administration of Rescue Medication Within 48 Hours

   Count of patients that had first administration of rescue medication within 48 Hours

   Time frame: up to 48 hours of chemotherapy

5. Number of Doses of Rescue Medications Used

   Time frame: Days 1-7 of each cycle

6. Side Effects of Antiemetic Medications Used

   Time frame: Up to 3 months

7. Severity of Nausea

   Count of participants with severe nausea

   Time frame: Up to 3 months

8. Quality of Life

   Time frame: Up to 3 months

Baseline characteristics