Bossi, P., Cortinovis, D., Fatigoni, S., Cossu Rocca, M., Fabi, A., Seminara, P., . . . Roila, F. (2017). A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin. Annals of Oncology, 28, 2547–2551.

To determine the effectiveness of ginger on the incidence and intensity of delayed nausea for patients on HEC (cisplatin)

Patients scheduled to receive high-dose cisplatin for two or more chemotherapy cycles were randomized to receive standardized ginger preparation 120 mg per day [two capsules of 40 mg twice daily] (16 mg gingerols plus 1.12 mg shogaoil) or placebo in addition to standard antiemetics (NK1 RA and 5-HT_³ RA on day 1 and dexamethasone on days 1-4) for a period of two chemotherapy cycles; nearly 45 days.

• N = 244 patients (121 ginger; 123 placebo)    
• AGE: Mean = 59.2 years
• MALES: 65.6% (ginger 68.6%, placebo 62.6%)  
• FEMALES: 34.4% (ginger 31.4%, placebo 37.4%)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Chemotherapy naïve, solid tumor (lung, head and neck cancer, planned to receive two or more cycles of > 50 mg cisplatin) 
• OTHER KEY SAMPLE CHARACTERISTICS: No ANV before fist HEC cycle

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: Six Italian oncology centers

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Elder care

Randomized, double-blind, placebo-controlled

Visual analog scale, 0–100 mm for nausea incidence and intensity, Functional Living Index Emesis (impact of nausea am daily living), Brief Fatigue Inventory questionnaire (impact of fatigue)

No significant differences between the two groups in relation to incidence of delayed nausea, intercycle nausea, and anticipatory nausea during the first and second cycle. In ginger group; men with lung cancer experienced a higher incidence of significant delayed and intercycle nausea (p < 0.05), incidence of delayed nausea was higher among patients with lung cancer in the ginger group than placebo (p = 0.042), no differences in FLIE and BFI between the two groups; a benefit of ginger over placebo in terms of FLIE for female versus male patients and in head/neck cancer versus lung cancer. No differences in experienced adverse effects between the two groups.

Ginger had no beneficial effect in reducing CINV (delayed, anticipatory, and intercycle) associated with HEC.

• Measurement validity/reliability questionable 
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: No stratification for the gender and the age group; using HEC, using VAS to measure incidence and intensity of nausea, not measuring the acute nausea, using a standardized ginger extract is impractical and could affect the generalizability

Daily ginger is safe; some patient might experience an increase in gastrointestinal symptoms.