Clinical trial NCT00064272: UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Official title: Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: nausea and vomiting
unspecified adult solid tumor, protocol specific
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2003-07-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Most efficacious dose
measure: Safety
measure: Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)
Secondary outcomes:
Other outcomes:
Locations:
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center CCOP Research Base
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Bronx
country: United States
facility: MBCCOP - Our Lady of Mercy Cancer Center
state: New York
city: San Juan
country: Puerto Rico
facility: MBCCOP - San Juan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Suzanna Zick, MPH, ND
role: STUDY_CHAIR
References: