Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

NCT00040742 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000069401U10CA037420URCC U1902URCC-0114
• Study Type: interventional
• Target: 745
• Locations: 1 country
• Sites: 19

Brief Summary

RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy. PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer.

Conditions

Nausea; Vomiting

Keywords

nausea; vomiting

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of Peak Acute Nausea

  Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings. Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure. Negative values for this outcome are favorable.

  3-4 days on study drug

Secondary Outcomes (1)

• Average Nausea Severity

  3-4 days on study drug

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

Other: placebo

0.5g ginger

EXPERIMENTAL

Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

Dietary Supplement: ginger; Other: placebo

1.0g ginger

EXPERIMENTAL

Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

Dietary Supplement: ginger; Other: placebo

1.5g ginger

EXPERIMENTAL

Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

Dietary Supplement: ginger

Interventions

ginger DIETARY_SUPPLEMENT

Given orally

0.5g ginger; 1.0g ginger; 1.5g ginger

placebo OTHER

Given orally

0.5g ginger; 1.0g ginger; Placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of cancer and be scheduled to receive at least 3 courses of chemotherapy * Scheduled to receive chemotherapy with no planned interruption by radiotherapy or surgery * Chemotherapy courses must be separated by at least 2 weeks from day 1 to day 1 of next course * Must have experienced nausea of any degree of severity after completion of the first study-related course of chemotherapy * Received a prior 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone (DM) given at any dose and by any route (or equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of course 1 of chemotherapy * Scheduled to receive a 5-HT3 receptor antagonist antiemetic with DM (or equivalent dose of IV MePRDL) on day 1 of courses 2 and 3 of chemotherapy * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm\^3 at second course of chemotherapy * No prior bleeding or blood coagulation disorder (e.g., thrombocytopenia or platelet dysfunction) Hepatic: * No prior coagulation factor deficiency Renal: * Not specified Cardiovascular: * No prior vascular defect Other: * Able to understand English * No concurrent or impending bowel obstruction PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent interferon therapy Chemotherapy: * See Disease Characteristics * At least 6 months since other prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No concurrent warfarin or heparin for therapeutic anticoagulation * Concurrent low-dose warfarin for maintenance of venous access allowed * Concurrent rescue medications for control of symptoms caused by the cancer or its treatment allowed as clinically indicated

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gary Morrow: lead
• National Cancer Institute (NCI): collaborator

Study Sites (19)

MBCCOP - Gulf Coast

Mobile, Alabama, 36606, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612-7323, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

CCOP - North Shore University Hospital

Manhassett, New York, 11030, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Two main weaknesses of the study, which should be controlled for in future studies, were not controlling for chemotherapy regimens (i.e., high versus low emetogenic regimens) or the severity level of nausea before enrollment.

Results Point of Contact

• Title: Charles E. Heckler, PhD, MS. Research Assistant Professor
• Organization: University of Rochester Medical Center

checkler@urmc.rochester.edu

585-273-1141

Study Officials

• Julie L. Ryan, PhD, MPH

  University of Rochester

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, URCC CCOP Research Base

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2003
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 9, 2015
• Results First Posted: March 10, 2015

Record last verified: 2015-10

Locations

US (19)