Ginger Control of Chemotherapy Induced Nausea and Vomiting
Ginger Control of Chemotherapy Induced Nausea and Vomiting
This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and
 severity of chemotherapy induced nausea and vomiting.
Chemotherapy induced nausea and vomiting significantly reduces patients' quality of life,
 increases fatigue, anxiety, and increases costs of health care delivery. Ginger (Zingiber
 officinalis) is already used in traditional folk medicine to treat nausea and vomiting in
 various populations. Ginger's ability to block 5-HT3 receptors and its free-radical
 scavenging in the intestines suggest that it may be beneficial for reducing both the
 prevalence and severity of chemotherapy induced nausea and vomiting. Despite ginger's
 possible benefits in reducing the prevalence and severity of chemotherapy induced nausea and
 vomiting, no dosing and/or safety studies have been performed.

 This study will assess the efficacy and safety of two dose levels (1000 mg, or 2000 mg,
 orally/day) of Zingiber officinalis extract (standardized for 5% gingerols) in patients
 undergoing chemotherapy (cisplastin or adriamycin) who have experienced at least one episode
 of chemotherapy induced nausea and vomiting despite optimal conventional medical therapy. The
 primary aim of the study is to determine the most efficacious dose of powdered ginger-root
 for reducing the prevalence and severity of acute nausea and vomiting. Secondary aims of the
 study include (1) determination of the most efficacious dose of powdered ginger-root for
 reducing the prevalence and severity of delayed nausea and vomiting; (2) assessment of the
 safety of different doses of oral powdered ginger root in patients receiving chemotherapy;
 and (3) determination if study participants can discern if they are receiving placebo or
 ginger. Participants receiving either adriamycin or cisplatin for cancer related treatment
 will be randomized to receive one of two doses of powdered ginger or placebo immediately
 prior to chemotherapy infusion. Participants will be followed for 72 hours after infusion in
 order to assess frequency and severity of nausea and vomiting. Baseline and 72 hour post
 chemotherapy labs will be used to assess safety profile of ginger.
Inclusion criteria:

 -  Confirmed diagnosis of cancer and currently receiving chemotherapy

 -  Currently being treated with any chemotherapeutic agent at any dose, and have
 experienced nausea and/or vomiting from a previous round of chemothearpy

 -  Scheduled to receive a 5-HT3 receptor antagonist antiemetic: ondansetron (Zofran®)
 granistron (Kytril®), tropisetron (Navoban®) or dolasetron mesylate (Anzemet®),
 palanosetron (Alozi) and/or the NK1 antagonist aprepitant (Emend)

 -  Must be able to swallow capsules

 -  Must be able to understand English or Spanish, complete questionnaires in English or
 Spanish

 -  Women of childbearing age to use appropriate birth control

 Exclusion criteria:

 -  Chemotherapy regimens with multiple-day doses

 -  Clinical evidence of current or impending bowel obstruction or symptomatic brain
 metastases

 -  Concurrent radiotherapy that is classified as high or intermediate risk of
 causing nausea and vomiting; total body irradiation, hemi-body, upper abdomen,
 abdominal-pelvic mantle, cranium, craniospinal irradiation

 -  Pregnant or lactating

 -  Patients with a history of a bleeding disorder(s) or those experiencing
 thrombocytopenia

 -  Currently be taking ginger or have taken ginger in the last month

 -  Have an allergy to ginger