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Arslan et al. (2015): Oral Intake of Ginger for Chemotherapy-Induced Nausea and Vomiting Among Women With Breast Cancer: Difference between revisions

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{{Reference
{{Reference
|Reference=Oral Intake of Ginger for Chemotherapy-Induced Nausea and Vomiting Among Women With Breast Cancer
|Reference=Publication: Oral Intake of Ginger for Chemotherapy-Induced Nausea and Vomiting Among Women With Breast Cancer
}}
}}
{{Study Note}}
 
=Brief summary=
=Brief summary=
In this randomized, controlled study, 60 breast cancer patients received either an additional 500mg of ginger powder (not standardized, mixed with yoghurt) or chemotherapy alone. The first dose was taken 30 minutes before the start of chemotherapy and was then continued over the 3 days of the cycle. Both arms were given other standard anti-nausea and anti-vomiting medications, including aprepitant. The combination of chemotherapy regimens that the patients received caused severe nausea/vomiting. From the 2nd day of treatment, the ginger arm had significantly less nausea/vomiting than the arm without this additive, and the severity was also lower. 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.
In this randomized, controlled study, 60 breast cancer patients received either an additional 500mg of ginger powder (not standardized, mixed with yoghurt) or chemotherapy alone. The first dose was taken 30 minutes before the start of chemotherapy and was then continued over the 3 days of the cycle. Both arms were given other standard anti-nausea and anti-vomiting medications, including aprepitant. The combination of chemotherapy regimens that the patients received caused severe nausea/vomiting. From the second day of treatment, the ginger arm had significantly less nausea/vomiting than the arm without this additive, and the severity was also lower. 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.




In dieser randomisiert, kontrollierten Studie erhielten 60 Brustkrebspatientinnen entweder zusätzlich 500mg Ingwerpulver (nicht standardisiert hergestellt, mit Joghurt vermischt) oder nur Chemotherapie. Die erste Einnahme erfolgte 30 Minuten vor Chemostart und wurde dann über die 3 Zyklustage fortgesetzt. Für beide Gruppen gab es weitere Standardmedikamente gegen Übelkeit und Erbrechen, u.a. auch Aprepitant. Die Kombination des Chemoregimes, das die Patientinnen erhielten, ruft starke Übelkeit/Erbrechen hervor. Ab dem 2. Einnahmetag hatte die Ingwergruppe signifikant weniger Übelkeit/Erbrechen als die Gruppe ohne diesen Zusatz, auch die Stärke war geringer. 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.
In dieser randomisiert, kontrollierten Studie erhielten 60 Brustkrebspatientinnen entweder zusätzlich 500mg Ingwerpulver (nicht standardisiert hergestellt, mit Joghurt vermischt) oder nur Chemotherapie. Die erste Einnahme erfolgte 30 Minuten vor Chemostart und wurde dann über die 3 Zyklustage fortgesetzt. Für beide Gruppen gab es weitere Standardmedikamente gegen Übelkeit und Erbrechen, u.a. auch Aprepitant. Die Kombination des Chemoregimes, das die Patientinnen erhielten, ruft starke Übelkeit/Erbrechen hervor. Ab dem zweiten Einnahmetag hatte die Ingwergruppe signifikant weniger Übelkeit/Erbrechen als die Gruppe ohne diesen Zusatz, auch die Stärke war geringer. 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=
=Study Design=
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{{RCT study general properties
{{RCT study general properties
|Inclusion criteria=Female with stage II or III breast cancer, having received previous surgical treatment for breast cancer, currently receiving chemotherapy with adjuvant anthracycline (chemotherapy protocols: anthracycline, cyclophosphamide [Cytoxan®], doxorubicin [Adriamycin®], and 5-fluorouracil [Adru ci l®]), receiving palonosetron-aprepitant antiemetic treatment, being at least in the second cycle of chemotherapy, and having experienced chemotherapy-induced nausea with a severity of 3 or higher during the previous cycles
|Inclusion criteria=Female with stage II or III breast cancer, having received previous surgical treatment for breast cancer, currently receiving chemotherapy with adjuvant anthracycline (chemotherapy protocols: anthracycline, cyclophosphamide [Cytoxan®], doxorubicin [Adriamycin®], and 5-fluorouracil [Adrucil®]), receiving palonosetron-aprepitant antiemetic treatment, being at least in the second cycle of chemotherapy, and having experienced chemotherapy-induced nausea with a severity of 3 or higher during the previous cycles
|Exclusion criteria=NI
|Exclusion criteria=NI
|N randomized=60
|N randomized=60
|Analysis=NI
|Analysis=NI
|Specifications on analyses=Mann-Whitney U test
|Specifications on analyses=Only included participants (n=60) reported, NI regarding number of randomized patients
|Countries of data collection=Turkey
|Countries of data collection=Turkey
|LoE=Level 2 Oxford 2011
|LoE=2b Oxford 2009
|Outcome timeline=T1: Day 1 (Day of the chemotherapy)
|Outcome timeline=T1: Day 1 (i.e. day of the chemotherapy infusion)
T2: Day 2
 
T2: Day 2 (i.e. day after chemotherapy infusion)
 
T3: Day 3
T3: Day 3
T4: Day 4
T4: Day 4
T5: Day 5
T5: Day 5
}}
}}
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{{Characteristics of participants
{{Characteristics of participants
|Setting=Curative
|Setting=Curative, Adjuvant
|Types of cancer=Breast Cancer
|Types of cancer=Breast Cancer
|Stage cancer=Advanced Stage
|Stage cancer=Early Stage, Advanced Stage
|Cancer stage specification=Stage II or III breast cancer
|Cancer stage specification=Stage II or III breast cancer, no significant differences between arms in cancer stage (p > 0.05)
|Comorbidity=NI
|Comorbidity=NI
|Current cancer therapy=Chemotherapy
|Current cancer therapy=Chemotherapy
|Specifications on cancer therapies=Chemotherapy with adjuvant anthracycline (chemotherapy protocols: anthracycline, cyclophosphamide [Cytoxan®], doxorubicin [Adriamycin®], and 5-fluorouracil [Adru ci l®])
|Specifications on cancer therapies=Chemotherapy with adjuvant anthracycline (chemotherapy protocols: anthracycline, cyclophosphamide, doxorubicin, and 5-fluorouracil), no significant differences between arms in chemotherapy  characteristics (p > 0.05)
|Previous cancer therapies=NI
|Previous cancer therapies=Surgery
|Gender=Female
|Gender=Female
|Gender specifications=100% female
|Gender specifications=100% female
Line 56: Line 60:
|Arm type=Intervention
|Arm type=Intervention
|Number of participants (arm)=30
|Number of participants (arm)=30
|Drop-out=N = 0
|Drop-out=Only included participants (n=30) reported, NI regarding number of randomized patients or drop-out
|Drop-out reasons=NA
|Drop-out reasons=NA
|Intervention=Powered ginger
|Intervention=Powered ginger
|Dosage and regime=Daily dose 2x500mg ginger powder with a spoonful of yogurt, from 30min before Cth, for 3 days, over two cycles of Cth
 
+ Antiemetic treatment: palonosetron, dexamethasone, an antihistamine, ranitidine, aprepitant
|Dosage and regime=Daily dose 2x500mg ginger powder with a spoonful of yogurt for 3 days, first dose 30min before start of Chemotherapy
|One-time application=No
|One-time application=No
|Duration in days=3
|Duration in days=3
|Side Effects / Interactions=No side effects were reported
|Side Effects / Interactions=No side effects reported
|Order number=1
|Order number=1
|Arm topic=Ginger
}}
}}
{{Arm
{{Arm
|Arm type=Placebo
|Arm type=Passive control
|Number of participants (arm)=30
|Number of participants (arm)=30
|Drop-out=N = 0
|Drop-out=Only included participants (n=30) reported, NI regarding number of randomized patients or drop-out
|Drop-out reasons=NA
|Drop-out reasons=NA
|Intervention=No intervention apart from the standard antiemetics
|Intervention=TAU (treatment as usual), i.e. antiemetic treatment: palonosetron, dexamethasone, an antihistamine, ranitidine, aprepitant
|Dosage and regime=Standard antiemetic therapy:
|Dosage and regime=NI
Day of chemotherapy: palonosetron, dexamethasone, an antihistamine, ranitidine (i.v. in each case)
30min before chemotherapy: Aprepitant (125mg p.o.)
Day 2, 3: Aprepitant (80mg p.o.)
|One-time application=No
|One-time application=No
|Duration in days=3
|Duration in days=-999
|Side Effects / Interactions=NI
|Side Effects / Interactions=NA
|Order number=2
|Order number=2
|Arm topic=Ginger
}}
}}
{{Arm Overview}}
{{Arm Overview}}
Line 84: Line 89:


{{Outcome
{{Outcome
|Outcome type=Primary
|Outcome type=NI
|Outcome name=Nausea
|Outcome name=CINV (Chemotherapy-Induced Nausea and Vomiting)
|Outcome specification=Nausea severity
|Outcome specification=Nausea severity
|Type of measurement=VAS (Visual Analogue Scale)
|Type of measurement=VAS (Visual Analogue Scale)
|Results during intervention=NA
|Results during intervention=''Daywise comparison''
|Results after intervention=Severity of nausea:
 
at T2 (day2)-T5 (day 5) Intervention-arm significantly less nausea than placebo-arm.
At T2 (day2)-T5 (day 5) intervention arm significantly less nausea than control arm, VAS mean (SD) for intervention vs. control:
VAS (Mean±SD) Intervention-arm vs. placebo-arm:
T2 (day 2): 3.8±1.9 vs. 6.3±1.9 (p<0.001)
T3 (day 3): 3.8±1.8 vs. 6.5±1.8 (p=0.001)
T4 (day 4): 3.7±1.9 vs. 6.3±1.8 (p=0.001)
T5 (day 5): 2.8±1.7 vs. 5.4±2.3 (p=0.001); no sign. Difference for T1 (day 1)


Mean over T1 (day 1)-T5 (day 5): Intervention-arm significantly less nausea than placebo-arm.
T2 (day 2): 3.8 (1.9) vs. 6.3 (1.9), p<0.001
VAS (Mean±SD) Intervention-arm vs. placebo-arm: 3±1.5 vs. 5.1±1.5 (p<0.001)
 
   
T3 (day 3): 3.8 (1.8) vs. 6.5 (1.8), p=0.001
With regard to acute and delayed nausea, the severity was lower in intervention-arm than in placebo-arm.
 
VAS (Mean±SD) intervention-arm vs. placebo-arm:
T4 (day 4): 3.7 (1.9) vs. 6.3 (1.8), p=0.001
Acute: 1.6±1.1 vs. 3.9±1.6 (p<0.001) (n= 36 (intervention-arm:15, placebo-arm: 21))
 
Delayed: 3.6±1.8 vs. 6.1±1.7 (p<0.001)
T5 (day 5): 2.8 (1.7) vs. 5.4 (2.3), p=0.001; no significant difference for T1 (day 1) (p=0.15)
|Bias arising from the randomization process=?
 
|Bias due to deviation from intended intervention (assignment to intervention)=?
 
 
''Mean after intervention''
 
Intervention arm significantly less nausea than control arm, VAS mean (SD) for intervention vs. control: 3 (1.5) vs. 5.1 (1.5), p<0.001
|Results after intervention=''Acute and delayed nausea''
 
Severity lower in intervention arm than in control arm, VAS mean (SD) for intervention vs. coontrol:
 
- acute: 1.6 (1.1) vs. 3.9 (1.6), p<0.001  
 
- delayed: 3.6 (1.8) vs. 6.1 (1.7), p<0.001
|Bias arising from the randomization process=low risk
|Bias due to deviation from intended intervention (assignment to intervention)=high risk
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias due to missing outcome data=high risk
|Bias in measurement of the outcome=?
|Bias in measurement of the outcome=some concerns
|Bias in selection of the reported result=?
|Bias in selection of the reported result=low risk
|Other sources of bias=?
|Other sources of bias=NA
|Overall RoB judgment=?
|Overall RoB judgment=high risk
|Order number=1
|Order number=1
|Outcome topic=Ginger
}}
}}
{{Outcome
{{Outcome
|Outcome type=Primary
|Outcome type=NI
|Outcome name=Vomiting
|Outcome name=CINV (Chemotherapy-Induced Nausea and Vomiting)
|Outcome specification=Frequency of vomiting
|Outcome specification=Frequency of vomiting
|Type of measurement=Diary questionnaire
|Type of measurement=Diary questionnaire
|Results during intervention=NA
|Results during intervention=''Daywise comparison''
|Results after intervention=Frequency of vomiting: at T2 (day 2), T3 (day 3), T5 (day 5): Intervention-arm significantly less frequent vomiting than placebo-arm.
 
Number of vomiting episodes (Mean±SD) intervention-arm vs. placebo-arm:
At T2 (day2), T3 (day 3) and T5 (day 5) intervention arm significantly less frequent vomiting than control arm, Number of vomiting episodes mean (SD) for intervention vs. control:
T2 (day 2): 0±0.1 vs. 0.3±0.6 (p=0.01)
 
T3 (day 3): 0±0.1 vs. 0.2±0.4 (p=0.01)
T2 (day 2): 0 (0.1) vs. 0.3 (0.6), p=0.01
T5 (day 5): 0±0 vs. 0.2±0.4 (p=0.04)
 
T3 (day 3): 0 (0.1) vs. 0.2 (0.4), p=0.01
 
T5 (day 5): 0 (0) vs. 0.2 (0.4), p=0.04; no significant difference for T1 (day 1) or T4 (day 4) (p=0.21 and 0.07)
 
''Mean after intervention''


Mean value over T1-T5 (day 1- day 5) : Intervention-arm significantly less frequent vomiting than placebo-arm.
Intervention arm significantly less frequent vomiting than control arm, number of vomiting episodes mean (SD) for intervention vs. control: 0 (0) vs. 0.2 (0.3), p=0.011
Number of vomiting episodes (Mean±SD) Intervention-arm vs. placebo-arm:
|Results after intervention=NI
0±0 vs. 0.2±0.3 (p=0.011)
|Bias arising from the randomization process=low risk
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=high risk
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias due to missing outcome data=high risk
|Bias in measurement of the outcome=?
|Bias in measurement of the outcome=some concerns
|Bias in selection of the reported result=?
|Bias in selection of the reported result=low risk
|Other sources of bias=?
|Other sources of bias=NA
|Overall RoB judgment=?
|Overall RoB judgment=high risk
|Order number=2
|Order number=2
|Outcome topic=Ginger
}}
}}
{{Outcome
{{Outcome
|Outcome type=Primary
|Outcome type=NI
|Outcome name=Retching
|Outcome name=CINV (Chemotherapy-Induced Nausea and Vomiting)
|Outcome specification=Frequency of retching
|Outcome specification=Frequency of retching
|Type of measurement=Diary questionnaire
|Type of measurement=Diary questionnaire
|Results during intervention=NA
|Results during intervention=''Daywise comparison''
|Results after intervention=No significant arm difference at all time points
 
No significant arm difference at all time points:
 
Day 1: p=0.08
Day 1: p=0.08
Day 2: p=0.29
Day 2: p=0.29
Day 3: p=0.17
Day 3: p=0.17
Day 4: p= 0.16
Day 4: p= 0.16
Day 5: p=0.42
Day 5: p=0.42
|Bias arising from the randomization process=?
 
|Bias due to deviation from intended intervention (assignment to intervention)=?
 
''Mean after intervention''
 
No significant difference in number of retching episodes, p=0.141
|Results after intervention=NI
|Bias arising from the randomization process=low risk
|Bias due to deviation from intended intervention (assignment to intervention)=high risk
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias due to missing outcome data=high risk
|Bias in measurement of the outcome=?
|Bias in measurement of the outcome=some concerns
|Bias in selection of the reported result=?
|Bias in selection of the reported result=low risk
|Other sources of bias=?
|Other sources of bias=NA
|Overall RoB judgment=?
|Overall RoB judgment=low risk
|Order number=3
|Order number=3
|Outcome topic=Ginger
}}
}}
{{Outcome Overview}}
{{Outcome Overview}}
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{{Funding and Conflicts of Interest
{{Funding and Conflicts of Interest
|Funding=NI
|Funding=NI
|Conflicts of Interest=According to information no conflicts of interest.
|Conflicts of Interest=According to authors no conflicts of interest
}}
}}
=Further points for assessing the study=
=Further points for assessing the study=


{{Further points for assessing the study
{{Further points for assessing the study
|power analysis performed=?
|power analysis performed=Yes
|Sample size corresponds to power analysis=?
|Sample size corresponds to power analysis=Yes
|Reasons given for samples being too small according to power analysis=?
|Reasons given for samples being too small according to power analysis=NA
|Samples sufficiently large=?
|Samples sufficiently large=NA
|Ethnicity mentioned=?
|Ethnicity mentioned=NI
|Other explanations for an effect besides the investigated intervention=?
|Other explanations for an effect besides the investigated intervention=Yes
|Possibility of attention effects=?
|Possibility of attention effects=Possibly during first administration of ginger under researcher’s supervision
|Possibility of placebo effects=?
|Possibility of placebo effects=Yes due to lack of placebo arm
|Other reasons=?
|Other reasons=No
|Correct use of parametric and non-parametric tests=?
|Correct use of parametric and non-parametric tests=Yes
|Correction for multiple testing=?
|Correction for multiple testing=No
|Measurement of compliance=?
|Measurement of compliance=No
|Blinding reliable=?
|Consistent reporting in numbers=Yes
|Check whether blinding was successful=?
|Comprehensive and coherent reporting=No
|Consistent reporting in numbers=?
|Cross-over=No
|Comprehensive and coherent reporting=?
|sufficient washout period=NA
|Cross-over=?
|Tested for carry-over effects=NA
|sufficient washout period=?
|Were sequence effects tested=NA
|Tested for carry-over effects=?
|Effect sizes reported=No
|Were sequence effects tested=?
|Were side effects systematically recorded=No
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=Yes
|Were side effects systematically recorded=?
|Ethics / CoI / Funding=Yes
|Side effects taken into account in the interpretation of the results=?
|Blinding reliable=No
|Ethics / CoI / Funding=?
|Check whether blinding was successful=NA
}}
}}
{{Additional Notes}}
{{Additional Notes}}

Latest revision as of 15:31, 30 November 2024


Reference ↗
Title Oral Intake of Ginger for Chemotherapy-Induced Nausea and Vomiting Among Women With Breast Cancer
Topic Ginger
Author Arslan, M, Özdemir, L
Year 2015
Journal Clinical Journal of Oncology Nursing
DOI https://doi.org/10.1188/15.CJON.E92-E97

Brief summary

In this randomized, controlled study, 60 breast cancer patients received either an additional 500mg of ginger powder (not standardized, mixed with yoghurt) or chemotherapy alone. The first dose was taken 30 minutes before the start of chemotherapy and was then continued over the 3 days of the cycle. Both arms were given other standard anti-nausea and anti-vomiting medications, including aprepitant. The combination of chemotherapy regimens that the patients received caused severe nausea/vomiting. From the second day of treatment, the ginger arm had significantly less nausea/vomiting than the arm without this additive, and the severity was also lower. 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.


In dieser randomisiert, kontrollierten Studie erhielten 60 Brustkrebspatientinnen entweder zusätzlich 500mg Ingwerpulver (nicht standardisiert hergestellt, mit Joghurt vermischt) oder nur Chemotherapie. Die erste Einnahme erfolgte 30 Minuten vor Chemostart und wurde dann über die 3 Zyklustage fortgesetzt. Für beide Gruppen gab es weitere Standardmedikamente gegen Übelkeit und Erbrechen, u.a. auch Aprepitant. Die Kombination des Chemoregimes, das die Patientinnen erhielten, ruft starke Übelkeit/Erbrechen hervor. Ab dem zweiten Einnahmetag hatte die Ingwergruppe signifikant weniger Übelkeit/Erbrechen als die Gruppe ohne diesen Zusatz, auch die Stärke war geringer. 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 Prospective
Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals Monocentric
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 No
Is randomized Yes
Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control No
Number of arms 2

Study characteristics

Inclusion criteria Female with stage II or III breast cancer, having received previous surgical treatment for breast cancer, currently receiving chemotherapy with adjuvant anthracycline (chemotherapy protocols: anthracycline, cyclophosphamide [Cytoxan®], doxorubicin [Adriamycin®], and 5-fluorouracil [Adrucil®]), receiving palonosetron-aprepitant antiemetic treatment, being at least in the second cycle of chemotherapy, and having experienced chemotherapy-induced nausea with a severity of 3 or higher during the previous cycles
Exclusion criteria NI
N randomized 60
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. NI
Specifications on analyses Only included participants (n=60) reported, NI regarding number of randomized patients
Countries of data collection Turkey
LoE Level of evidence 2b Oxford 2009
Outcome timeline Data collection times T1: Day 1 (i.e. day of the chemotherapy infusion)

T2: Day 2 (i.e. day after chemotherapy infusion)

T3: Day 3

T4: Day 4

T5: Day 5

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. Curative, Adjuvant
Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included Breast Cancer
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 Early Stage, Advanced Stage
Specifications on cancer stages Stage II or III breast cancer, no significant differences between arms in cancer stage (p > 0.05)
Comorbidities NI
Current cancer therapies Chemotherapy
Specifications on cancer therapies Chemotherapy with adjuvant anthracycline (chemotherapy protocols: anthracycline, cyclophosphamide, doxorubicin, and 5-fluorouracil), no significant differences between arms in chemotherapy characteristics (p > 0.05)
Previous cancer therapies Surgery
Gender Female
Gender specifications 100% female
Age groups Adults (18+)
Age groups specification Mean: 48.5 years

Arms

Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment Intervention
Number of participants (arm) N randomized 30
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date Only included participants (n=30) reported, NI regarding number of randomized patients or drop-out
Drop-out reasons NA
Intervention Powered ginger

+ Antiemetic treatment: palonosetron, dexamethasone, an antihistamine, ranitidine, aprepitant

Dosage and regime Daily dose 2x500mg ginger powder with a spoonful of yogurt for 3 days, first dose 30min before start of Chemotherapy
One-time application No
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. 3
Side effects / Interactions No side effects reported
Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment Passive control
Number of participants (arm) N randomized 30
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date Only included participants (n=30) reported, NI regarding number of randomized patients or drop-out
Drop-out reasons NA
Intervention TAU (treatment as usual), i.e. antiemetic treatment: palonosetron, dexamethasone, an antihistamine, ranitidine, aprepitant
Dosage and regime NI
One-time application No
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. -999
Side effects / Interactions NA

Outcomes

CINV (Chemotherapy-Induced Nausea and Vomiting)

Outcome type As specificed by the authors NI
Outcome specification Nausea severity
Type of measurement VAS (Visual Analogue Scale)
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". Daywise comparison

At T2 (day2)-T5 (day 5) intervention arm significantly less nausea than control arm, VAS mean (SD) for intervention vs. control:

T2 (day 2): 3.8 (1.9) vs. 6.3 (1.9), p<0.001

T3 (day 3): 3.8 (1.8) vs. 6.5 (1.8), p=0.001

T4 (day 4): 3.7 (1.9) vs. 6.3 (1.8), p=0.001

T5 (day 5): 2.8 (1.7) vs. 5.4 (2.3), p=0.001; no significant difference for T1 (day 1) (p=0.15)


Mean after intervention

Intervention arm significantly less nausea than control arm, VAS mean (SD) for intervention vs. control: 3 (1.5) vs. 5.1 (1.5), p<0.001

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". Acute and delayed nausea

Severity lower in intervention arm than in control arm, VAS mean (SD) for intervention vs. coontrol:

- acute: 1.6 (1.1) vs. 3.9 (1.6), p<0.001

- delayed: 3.6 (1.8) vs. 6.1 (1.7), p<0.001

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process low risk
Bias due to deviation from intended intervention (assignment to intervention) high risk
Bias due to deviation from intended intervention (adhering to intervention) NA
Bias due to missing outcome data high risk
Bias in measurement of the outcome some concerns
Bias in selection of the reported result low risk
Other sources of bias NA
Overall RoB judgment high risk

CINV (Chemotherapy-Induced Nausea and Vomiting)

Outcome type As specificed by the authors NI
Outcome specification Frequency of vomiting
Type of measurement Diary questionnaire
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". Daywise comparison

At T2 (day2), T3 (day 3) and T5 (day 5) intervention arm significantly less frequent vomiting than control arm, Number of vomiting episodes mean (SD) for intervention vs. control:

T2 (day 2): 0 (0.1) vs. 0.3 (0.6), p=0.01

T3 (day 3): 0 (0.1) vs. 0.2 (0.4), p=0.01

T5 (day 5): 0 (0) vs. 0.2 (0.4), p=0.04; no significant difference for T1 (day 1) or T4 (day 4) (p=0.21 and 0.07)


Mean after intervention

Intervention arm significantly less frequent vomiting than control arm, number of vomiting episodes mean (SD) for intervention vs. control: 0 (0) vs. 0.2 (0.3), p=0.011

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". NI
Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process low risk
Bias due to deviation from intended intervention (assignment to intervention) high risk
Bias due to deviation from intended intervention (adhering to intervention) NA
Bias due to missing outcome data high risk
Bias in measurement of the outcome some concerns
Bias in selection of the reported result low risk
Other sources of bias NA
Overall RoB judgment high risk

CINV (Chemotherapy-Induced Nausea and Vomiting)

Outcome type As specificed by the authors NI
Outcome specification Frequency of retching
Type of measurement Diary questionnaire
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". Daywise comparison

No significant arm difference at all time points:

Day 1: p=0.08

Day 2: p=0.29

Day 3: p=0.17

Day 4: p= 0.16

Day 5: p=0.42


Mean after intervention

No significant difference in number of retching episodes, p=0.141

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". NI
Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process low risk
Bias due to deviation from intended intervention (assignment to intervention) high risk
Bias due to deviation from intended intervention (adhering to intervention) NA
Bias due to missing outcome data high risk
Bias in measurement of the outcome some concerns
Bias in selection of the reported result low risk
Other sources of bias NA
Overall RoB judgment low risk

Funding and Conflicts of Interest

Funding NI
Conflicts of Interest According to authors no conflicts of interest

Further points for assessing the study

Sample

Power analysis performed Yes
- Sample size corresponds to power analysis Yes
- Reasons for insufficient sample size based on power analysis NA
If no power analysis performed: at least moderate sample size (n >= 30 per arm) NA
Ethnicity mentioned NI

Alternative Explanation

Other explanations for an effect besides the investigated intervention Yes
- Possibility of attention effects Possibly during first administration of ginger under researcher’s supervision
- Possibility of placebo effects Yes due to lack of placebo arm
- Other reasons No

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 Yes
Correction for multiple testing No
Measurement of compliance No
Consistent reporting in numbers (figures, flowchart, abstract, results) Yes
Comprehensive and coherent reporting No
Cross-over No
- Sufficient washout period NA
- Tested for carry-over effects NA
- Tested for sequence effects NA

Interpretation of results

Effect sizes reported (clinical vs. statistical significance) No
Side effects systematically recorded No
Side effects considered in result interpretation Yes
Ethics votum Yes


Additional Notes

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