UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

NCT ID: NCT00064272

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31

Brief Summary

RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.

Detailed Description

OBJECTIVES:

Primary

• Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.

Secondary

• Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
• Compare the safety of these regimens in these patients.
• Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist).

• Arm I: Patients receive lower-dose oral ginger twice daily.
• Arm II: Patients receive higher-dose oral ginger twice daily.
• Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

Conditions

Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm I

Patients receive lower-dose oral ginger twice daily.

Group Type: EXPERIMENTAL

ginger extract

Intervention Type: DRUG

Given orally

Arm II

Patients receive higher-dose oral ginger twice daily.

Group Type: EXPERIMENTAL

ginger extract

Intervention Type: DRUG

Given orally

Arm III

Patients receive oral placebo twice daily.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

Interventions

ginger extract

Given orally

Intervention Type: DRUG

placebo

Given orally

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of cancer
• Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute)

• Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only)
• Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria:

• Agent is the same that is scheduled for the next round of chemotherapy
• Experienced nausea and/or vomiting of any severity (delayed or acute)
• Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy
• No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• No history of bleeding disorder
• No thrombocytopenia

Hepatic

• Not specified

Renal

• Not specified

Gastrointestinal

• Able to swallow capsules
• No gastric ulcer
• No clinical evidence of current or impending bowel obstruction

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to understand English
• Able to complete study questionnaires
• No allergy to ginger

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior chemotherapy regimens with multiple day doses

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas:

• Total body irradiation
• Hemi-body
• Upper abdomen
• Abdominal-pelvic mantle
• Cranium (radiosurgery)
• Craniospinal radiotherapy

Surgery

• Not specified

Other

• More than 1 week since prior ginger (teas, capsules, tinctures)
• No other concurrent ginger (teas, capsules, tinctures)

• Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed
• No concurrent therapeutic-doses of warfarin, aspirin, or heparin

• Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Suzanna Zick, MPH, ND

Role: STUDY_CHAIR

University of Michigan Rogel Cancer Center

Locations

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

University of Michigan Cancer Center CCOP Research Base

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

MBCCOP - Our Lady of Mercy Cancer Center

The Bronx, New York, United States

MBCCOP - San Juan

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

P30CA046592

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCUM-0201

Identifier Type: -

Identifier Source: secondary_id

CDR0000310163

Identifier Type: -

Identifier Source: org_study_id