UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (IRB 2003-551)

University of Michigan Rogel Cancer Center

Status and phase: Completed; Phase 2

Conditions: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Other: placebo; Drug: ginger extract

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00064272

CCUM-0201

P30CA046592 (U.S. NIH Grant/Contract)

CDR0000310163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

180 participants in 3 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive lower-dose oral ginger twice daily.

Treatment:

Drug: ginger extract

Arm II

Experimental group

Description:

Patients receive higher-dose oral ginger twice daily.

Treatment:

Drug: ginger extract

Arm III

Placebo Comparator group

Description:

Patients receive oral placebo twice daily.

Treatment:

Other: placebo