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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

— IRB 2003-551  

Official title:

Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064272
• Other study ID #: CDR0000310163
• Secondary ID: P30CA046592CCUM-
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2003
• Last updated: October 20, 2016
• Start date: May 2003

Study information

• Verified date: October 2016
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting
• Unspecified Adult Solid Tumor, Protocol Specific
• Vomiting

Intervention

Drug:
• ginger extract
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
Puerto Rico	MBCCOP - San Juan	San Juan
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	MBCCOP - Our Lady of Mercy Cancer Center	Bronx	New York
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Most efficacious dose
Primary	Safety
Primary	Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)