Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Condition: Nausea
MeSH terms: Nausea
Intervention: aprepitant; dexamethasone; granisetron hydrochloride; palonosetron hydrochloride; prochlorperazine; placebo
Intervention description: Given orally or IV; Given orally or IV; Given orally or IV; Given orally or IV; Given orally or IV; Given orally
Intervention MeSH terms: Dexamethasone; Aprepitant; Palonosetron; Granisetron; Prochlorperazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1021.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nausea and vomiting; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; inflammatory breast cancer; male breast cancer

Summary:

      RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine,
      aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which
      combination of antiemetic drugs is more effective in preventing nausea caused by
      chemotherapy.

      PURPOSE: This randomized phase III trial is comparing different combinations of granisetron,
      dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in
      preventing nausea in patients undergoing chemotherapy for breast cancer.
    

Eligibility criteria:

        Inclusion criteria:

          -  Have a diagnosis of cancer and be chemotherapy naive.

          -  Must be scheduled to receive a chemotherapy treatment containing doxorubicin
             hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any
             dose or schedule) without concurrent radiotherapy or interferon treatment

          -  Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.

          -  Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two
             weeks)are allowed.

          -  For the purposes of this study, Day 1 of chemotherapy will be defined as the day of
             administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.

          -  Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin,
             oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not
             allowed. Chemotherapy agents, other than those listed above, may be given orally,
             intravenously, or by continuous infusion on one or multiple days.

          -  Able to understand English

        Exclusion criteria:

          -  No symptomatic brain metastases

          -  No concurrent or impending bowel obstruction

          -  Regimens containing liposomal doxorubicin or cisplatin are not allowed.

          -  No concurrent pimozide, terfenadine, astemizole, or cisapride

          -  No concurrent doxorubicin hydrochloride liposome or cisplatin

          -  No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas,
             streptozocin, cisplatin, carboplatin, or oxaliplatin