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Protocol & Design
The other sections
of the research protocol containing information relevant to the
design of the study are presented below.
1.0
Subject Eligibility
Study patients must:
1.1 Have a diagnosis
of cancer and have never received chemotherapy in the past.
1.2 Be scheduled to
receive a chemotherapy treatment containing doxorubicin (any dose)
without concurrent radiotherapy or interferon treatment.
1.2.1 Chemotherapy
may be for adjuvant, neoadjuvant, curative or palliative intent.
1.2.2 Regimens with
multiple-day doses of cisplatin, doxorubicin, 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.
1.2.3 For the purposes
of this study, Day 1 of chemotherapy will be defined as the
day of administration of doxorubicin.
1.3
Be scheduled to receive a 5-HT3 receptor
antagonist antiemetic: ondansetron (Zofran®), granisetron
(Kytril®), tropisetron (Navoban®) or dolasetron mesylate
(Anzemet®), with dexamethasone on the day of treatment (Day
1).
1.4 Must not have clinical
evidence of current or impending bowel obstruction or symptomatic
brain metastases.
1.5 Be able to understand
English (all assessment instruments are in English).
1.6 Be 18 years of
age or older.
1.7
Give informed consent.
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