| Reference ↗
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| Title
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Efficacy of Ginger in Control of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients Receiving Doxorubicin- Based Chemotherapy
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| Topic
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Ginger
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| Author
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Ansari, M, Porouhan, P, Mohammadianpanah, M, Omidvari, S, Mosalaei, A, Ahmadloo, N, Nasrollahi, H, Hamedi, SH
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| Year
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2016
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| Journal
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Asian Pacific Journal of Cancer Prevention
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| DOI
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https://doi.org/10.14456/apjcp.2016.186/APJCP.2016.17.8.3877
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Study Note
Brief summary
150 breast cancer patients were randomly divided into two arms. One arm received 1000mg of ginger powder (not standardized) daily for 3 days during chemotherapy, the other arm received a placebo. The chemotherapy regime was strongly nausea- and vomiting-promoting. All patients were also given additional anti-nausea medication, including aprepitant. There were no arm differences, i.e. ginger was not superior to placebo, but one subarm benefited: the patients who received the chemotherapy regime doxorubicin 60 mg/m2 + cyclo-phosphamide 600 mg/m2 suffered significantly less vomiting when they took ginger. Adverse side effects were not reported. The study is not well reported, suggesting that the study was not methodologically well conducted and the results must be interpreted with caution.
150 Brustkrebspatientinnen wurden zufällig in zwei Gruppen geteilt. Die eine Gruppe erhielt über 3 Tage während der Chemo täglich 1000mg Ingwerpulver (nicht standardisiert hergestellt), die andere Gruppe erhielt ein Plazebo. Das Chemoregime war stark Brechreiz- und Übelkeit-fördernd. Allen Patientinnen wurde auch noch zusätzliche Medikamente gegen die Übelkeit gegeben, u.a. Aprepitant. Es gab keine Gruppenunterschiede, d.h. Ingwer war dem Plazebo nicht überlegen, allerdings profitierte eine Untergruppe: Die Patientinnen, die das Chemoregime Doxorubicin 60 mg/m2 + Cyclo-phosphamid 600 mg/m2 erhielten, litten bedeutsam unter weniger Erbrechen, wenn sie Ingwer eingenommen hatten. Unerwünschte Nebenwirkungen sind nicht berichtet. Die Studie ist nicht gut berichtet, so dass die Vermutung naheliegt, dass die Studie methodisch nicht gut durchgeführt worden ist und die Ergebnisse mit Vorsicht interpretiert werden müssen.
Study Design
| Prospective / Retrospective Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies;</br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies
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Prospective
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| Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
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Monocentric
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| Blinding No: Open, all parties are aware of group assignments;</br>Single: one party is unaware of group assignments (generally participants);</br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties
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Double
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| Is randomized
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Yes
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| Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
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No
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| Number of arms
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2
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Study characteristics
| Inclusion criteria
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Patients who were pathologically diagnosed with breast cancer, receiving AC, CAF or TAC chemotherapy regimen, receiving at least 3 chemotherapy cycles
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| Exclusion criteria
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History of previous malignancy or chemotherapy, history of other systemic diseases, metastatic condition or receiving other antiemetic drugs
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| N randomized
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150
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| Analysis PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.
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PP Analysis
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| Specifications on analyses
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Chi- square test, independent T-test and Mann-Whitney test
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| Countries of data collection
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Iran
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| LoE Level of evidence
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2b Oxford 2009
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| Outcome timeline Data collection times
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NI
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Characteristics of participants
| Setting Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.
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Curative
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| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
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Breast Cancer
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| Cancer stages Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis
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NI
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| Specifications on cancer stages
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NI
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| Comorbidities
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NI
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| Current cancer therapies
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Chemotherapy
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| Specifications on cancer therapies
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Chemotherapy regimens (n intervention vs. placebo arm):
- AC, i.e. doxorubicin60 mg/m2 +cyclophosphamid 600 mg/m2 (41 vs. 44)
- CAF, i.e. cyclophosphamide 500mg/m2 + doxorubicin 50mg/ m2 + 5-Fluorouracil 500mg/m2 (19 vs. 18)
- TAC, i.e. docetaxel 75mg/m2 + doxorubicin 50mg/m2 + cyclophosphamide 500mg/m2 (15 vs. 13)
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| Previous cancer therapies
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NI
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| Gender
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Female
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| Gender specifications
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100% female
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| Age groups
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Adults (18+)
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| Age groups specification
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Mean (range) in years: 48.6 (25-79)
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Arms
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Intervention
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| Number of participants (arm) N randomized
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75
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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N = 18
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| Drop-out reasons
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Forms not filled out correctly
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| Intervention
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Ginger capsules
+ Antiemetic treatment: dexamethasone, aprepitant, granisetron (before each cyle + first two days of each cyle)
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| Dosage and regime
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Daily dose 2x2 ginger capsules (250mg ginger powder each), every 12h for 3 days over 3 cycles, start not specified
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| One-time application
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No
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| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
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-999
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| Side effects / Interactions
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No ginger related side effects were reported.
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| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Placebo
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| Number of participants (arm) N randomized
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75
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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N = 13
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| Drop-out reasons
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Forms not filled out correctly
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| Intervention
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Placebo capsules
+ Antiemetic treatment: dexamethasone, aprepitant, granisetron (before each cyle + first two days of each cyle)
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| Dosage and regime
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Daily dose 2x2 capsules, every 12h for 3 days over 3 cycles, start not specified
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| One-time application
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No
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| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
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-999
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| Side effects / Interactions
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NI
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Outcomes
Nausea
| Outcome type As specificed by the authors
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NI
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| Outcome specification
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Nausea severity
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| Type of measurement
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Diary questionnaire, CTCAE (Common Terminology Criteria of Adverse Events)
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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Nausea (all three cycles): no significant difference for mean nausea in ginger vs. placebo arm
Subgroup analysis for different chemotherapies: no significant arm differences
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NI
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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low risk
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| Bias due to deviation from intended intervention (assignment to intervention)
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high risk
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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high risk
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| Bias in measurement of the outcome
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some concerns
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| Bias in selection of the reported result
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low risk
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| Other sources of bias
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NA
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| Overall RoB judgment
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high risk
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Vomiting
| Outcome type As specificed by the authors
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NI
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| Outcome specification
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Vomiting severity
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| Type of measurement
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Diary questionnaire, CTCAE (Common Terminology Criteria of Adverse Events)
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NA
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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Vomiting (all three cycles): no significant between arms
Among participants with the Chemotherapy regimen AC (doxorubicin+cyclophosphamide) in intervention arm significantly lower severity of vomiting than in placebo arm, mean (SD): 0.64 (0.87) vs. 1.13 (1.12), p<0.05
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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low risk
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| Bias due to deviation from intended intervention (assignment to intervention)
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high risk
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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high risk
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| Bias in measurement of the outcome
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some concerns
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| Bias in selection of the reported result
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low risk
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| Other sources of bias
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NA
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| Overall RoB judgment
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high risk
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Funding and Conflicts of Interest
| Funding
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University of Medical Sciences supported this study
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| Conflicts of Interest
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NI
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Further points for assessing the study
Sample
| Power analysis performed
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No
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| - Sample size corresponds to power analysis
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NA
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| - Reasons for insufficient sample size based on power analysis
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NA
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| If no power analysis performed: at least moderate sample size (n >= 30 per arm)
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Yes
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| Ethnicity mentioned
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No
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Alternative Explanation
| Other explanations for an effect besides the investigated intervention
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?
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| - Possibility of attention effects
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No
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| - Possibility of placebo effects
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No
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| - Other reasons
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NA
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Statistics
| Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing
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?
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| Correction for multiple testing
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?
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| Measurement of compliance
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Yes
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| Consistent reporting in numbers (figures, flowchart, abstract, results)
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Yes
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| Comprehensive and coherent reporting
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No
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| Cross-over
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No
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| - Sufficient washout period
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NA
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| - Tested for carry-over effects
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NA
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| - Tested for sequence effects
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NA
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Interpretation of results
| Effect sizes reported (clinical vs. statistical significance)
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No
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| Side effects systematically recorded
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NI
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| Side effects considered in result interpretation
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NA
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| Ethics votum
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NI
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Additional Notes
Adherence intervention-arm vs. placebo-arm: 76 % vs. 82 %
