Ginger for Chemotherapy-related Nausea in Cancer

PatientsJulie L. Ryan, PhD, MPH1

C. Heckler, PhD1, S.R. Dakhil, MD2, J. Kirshner, MD3, P.J. Flynn, MD4, J.T. Hickok, MD, MPH1, G.R. Morrow, PhD, MS1

1University of Rochester Medical Center, URCC CCOP, Rochester, NY; 2Witchita CCOP, Witchita, KS; 3HAOCNY CCOP, Syracuse, NY;

4Metro-MN CCOP, St. Louis Park, MN

Supported by NCI PHS grants U10CA37420 and 1R25CA10618

Chemotherapy-related Nausea• Most severe & distressing chemotherapy-related

side effects:– Nausea = #1– Vomiting = #5

• Nausea experienced by over 73% of cancer patients receiving chemotherapy.

• Onset: – Acute (0-24 hours after treatment)– Delayed (24-120 hours after treatment)

What is Nausea?• A subjective and unobservable

phenomenon

• Brain-Gut Connection• Enteric nervous system (2nd brain)• Neurotransmitters in the gut:

– Serotonin (5-HT3)

– Dopamine– Neurokinin

• Self assessment tools, such as diaries and visual analog scales, are gold standard for measuring nausea.

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Why Ginger?• Long history (~2500 years) of

medicinal use– Headaches, acid indigestion,

nausea, diarrhea, colds, arthritis, rheumatological conditions, muscular discomfort.

• North American Folklore– What your grandma always

told you!! • Potent anti-inflammatory • Anti-spasmodic activity in the gut http://www.bonappetit.com/images/tips_tools_ingredients/

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Research on Ginger & Chemotherapy-related Nausea• Effective

– Pace et al (1986): N = 41• Two-arm, randomized, placebo-controlled; 500mg Ginger

– Levine et al (2008): N = 28• Unblinded, three arm study (Protein with ginger)

• Ineffective– Zick et al (2008): N =162

• Three-arm, randomized, placebo-controlled; 1.0g & 2.0g Ginger

Central Illinois CCOP Gulf Coast MBCCOP North Shore University Hospital CCOPColumbia River CCOP Hawaii MBCCOP Northwest CCOPColumbus CCOP Hematology-Oncology of CNY CCOP Southeast Cancer Control ConsortiumDayton Clinical Oncology Program Kalamazoo CCOP University of Illinois at Chicago MBCCOPEvanston CCOP Kansas City CCOP Upstate Carolina CCOP

Grand Rapids CCOPMarshfield Clinic Research Foundation CCOP

Virginia Mason Research Center CCOP

Greenville CCOP Metro-Minnesota CCOP Wichita CCOPNevada Cancer Research Foundation CCOP

CCOPs

URCC

University of Rochester Cancer CenterCommunity Clinical Oncology Research Base

Map of Affiliates (2009)

Primary Objective

• To determine if ginger is more effective than placebo in controlling chemotherapy-related nausea on Day 1 of chemotherapy in patients receiving 5-HT3 receptor antagonist antiemetics.

Eligibility Criteria

• Cancer patients who experienced nausea with any chemotherapy cycle.

• Patients scheduled for at least 3 additional chemotherapy cycles.

• Patients scheduled to receive 5-HT3 receptor antagonist antiemetics on Day 1 of all chemotherapy cycles.

• Patients not taking warfarin (Coumadin®) or heparin.

Study Schema

Placebo0.5g Ginger1.0g Ginger1.5g Ginger

Study Schema

Key Points of Study• All patients received 5-HT3 receptor antagonist

antiemetics (i.e., Zofran®, Kytril®, etc.) on Day 1 of all cycles.

• All patients took ginger or placebo for six days, starting three days before chemotherapy.

• Patients reported nausea four times daily (morning, afternoon, evening, night):

1 7Not

Nauseated Extremely Nauseated

Patient Descriptives Total N = 644 cancer patients

90% female, 92% White, mean age = 53 Most common cancer types

Breast (66%), alimentary (6.5%), lung (6.1%) Previous Treatments

86% Surgery; 56% Chemotherapy; 7% Radiation

No exclusion based on chemotherapy regimenBoth moderately & highly emetic regimens

used.

No significant difference in drop-out rate between treatment arms.

Overall = 15%71% of patients completed all study

cycles.

Results

Day 1, Study Cycle 2 Day 1, Study Cycle 3

M = Morning (6 hrs.); A = Afternoon (12 hrs.); E = Evening (18 hrs.); N = Night (24 hrs.)

P=0.003 P=0.003Less

Less

Less

Less

No Significant Effect on Vomiting

Time of Day

-0.05

0.00

0.05

M A E N M A E N

Placebo 0.5g Ginger 1.0g Ginger 1.5g Ginger

Day 1, Study Cycle 2 Day 1, Study Cycle 3

Time of Day

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Conclusions

• Ginger supplementation at daily dose of 0.5g-1.0g significantly aids in reduction of nausea on the first day of chemotherapy.

• Reduced nausea will lead to improved quality of life for cancer patients during chemotherapy.

Acknowledgements

Gary R. Morrow, PhD, MSJoe Roscoe, PhDJane Hickok, MD

Charles Heckler, PhDBehavioral Medicine Unit

Community Clinical Oncology Program Affiliates

University of Rochester Medical Center &Wilmot Cancer Center

National Cancer Institute