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Panahi et al. (2012): Effect of Ginger on Acute and Delayed Chemotherapy-Induced Nausea and Vomiting: A Pilot, Randomized, Open-Label Clinical Trial

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Title Effect of Ginger on Acute and Delayed Chemotherapy-Induced Nausea and Vomiting: A Pilot, Randomized, Open-Label Clinical Trial
Topic Ginger
Author Panahi, Y, Saadat, A, Sahebkar, A, Hashemian, F, Taghikhani, M, Abolhasani, E
Year 2012
Journal Integrative Cancer Therapies
DOI https://doi.org/10.1177/15347354114332

Study Note

Brief summary

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 Women who had cancer (mainly new cases of advanced breast cancer diagnosed by the oncologist and thus undergoing their first experience of chemotherapy) who were initially assigned to the components of TEC regimen, including docetaxel, epirubicin, and cyclophosphamide
Exclusion criteria Participation in another study with different drugs; history of bone marrow or stem cell transplantation; presence of respiratory, cardiovascular, liver, renal, metabolic, or gastrointestinal diseases; and history of motion sickness
N randomized 100
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. PP Analysis
Specifications on analyses Between-arm (ginger vs control) comparisons were performed using independent-samples t test (for quantitative variables) or χ2 and Fisher’s exact test (for categorical variables)
Countries of data collection Iran
LoE Level of evidence Level 2 Oxford 2011
Outcome timeline Data collection times T1:0-6h after Chemotherapy

T2:6-24h after Chemotherapy T3: 2nd day T4: 3rd day T5: 4th day

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
Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included Breast Cancer, Other Cancers
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 Advanced Stage, NI
Specifications on cancer stages Mainly new cases of advanced breast cancer diagnosed by the oncologist
Comorbidities NI
Current cancer therapies Chemotherapy
Specifications on cancer therapies Patients experiencing their first trial of chemotherapy (Docetaxel, Epirubicin, Cyclophosphamid)
Previous cancer therapies No therapy
Gender Female
Gender specifications 100 % female
Age groups Adults (18+)
Age groups specification Age range = 35-74 years, mean(SD) = 51.83(9.18) 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 50
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date 13
Drop-out reasons Lost to follow-up or lack of compliance
Intervention Ginger capsules (dried ginger powder)


+ all antiemetic standardtherapy (Granisetron + Dexamethason)

Dosage and regime Daily dose 3x0.5g

Every 8h, starting 30min after 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. 4
Side effects / Interactions Heartburn, headache, vertigo
Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment Placebo
Number of participants (arm) N randomized 50
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date 9
Drop-out reasons Lost to follow-up or lack of compliance
Intervention Placebo


+ all antiemetic standardtherapy (Granisetron + Dexamethason)

Dosage and regime Every 8h, starting 30min after 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. 4
Side effects / Interactions NI

Outcomes

Nausea and Vomiting

Outcome type As specificed by the authors Primary
Outcome specification Prevalence of nausea, vomiting and 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". Prevalence of nausea intervention vs. placebo:
  • first 6 hours after chemotherapy: 24.3% vs. 41.5% (p=0.11, ns.)
  • 6-24h after chemotherapy: 35.1% vs. 58.5% (p=0.04, sign.)
  • second day: 45.9% vs. 55.0% (p=0.43, ns.)
  • third day: 54.0% vs. 55.0% (p=0.93, ns.)
  • fourth day: 56.8% vs. 47.5% (p=0.42)


Prevalence of vomiting and retching intervention vs. placebo:

  • first 6 hours after chemotherapy: 24.3% vs. 26.8% (p=0.80, ns.)
  • 6-24h after chemotherapy: 18.9% vs. 29.8% (p=0.26, ns.)
  • second day: 35.1% vs. 27.5% (p=0.47, ns.)
  • third day: 35.1% vs. 30.0% (p=0.63, ns.)
  • fourth day: 43.2% vs. 35.0% (p=0.46, ns.)
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". NA
Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process ?
Bias due to deviation from intended intervention (assignment to intervention) ?
Bias due to deviation from intended intervention (adhering to intervention) NA
Bias due to missing outcome data ?
Bias in measurement of the outcome ?
Bias in selection of the reported result ?
Other sources of bias ?
Overall RoB judgment ?

Nausea and Vomiting

Outcome type As specificed by the authors Secondary
Outcome specification Severity (Rhodes Index Scores) of Nausea, Vomiting, and 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". Intervention vs. placebo (Min, Mean(SD), Max):
  • first 6h after chemotherapy: 0, 3.22(4.45), 15 vs. 0, 2.98 ± 3.95, 13 (p=0.80, ns.)
  • 6-24h after chemotherapy: 0, 3.11(4.04), 16 vs. 0, 4.10(4.42), 17 (p=0.31, ns.)
  • second day: 0, 4. 35(4.84), 19 vs. 0, 4.32(4.36), 14 (p=0.98, ns.)
  • third day: 0, 4.78(4.82), 16 vs. 0, 4.22(5.06), 20 (p=0.62, ns.)
  • fourth day: 0, 5.70(5.60), 23 vs. 0, 4.47(5.45), 2 (p=0.33, ns.)
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". NA
Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process ?
Bias due to deviation from intended intervention (assignment to intervention) ?
Bias due to deviation from intended intervention (adhering to intervention) NA
Bias due to missing outcome data ?
Bias in measurement of the outcome ?
Bias in selection of the reported result ?
Other sources of bias ?
Overall RoB judgment ?

Nausea and Vomiting

Outcome type As specificed by the authors Secondary
Outcome specification Proportion of participants with none, mild, moderate, or severe symptoms of nausea, vomiting, and 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". Symptom severity intervention vs. placebo:
  • first 6h after chemotherapy: none: 48.6% vs. 53.7% (p=0.66), mild: 32.4% vs. 31.7% (p=0.94), moderate: 18.9% vs. 14.6% (p=0.61), severe: 0% vs. 0% (p=1.00, ns.)
  • 6-24h after chemotherapy: none: 45. 9% vs. 34.1% (p=0.29), mild: 40.5% vs. 46.13% (p=0.61), moderate: 13.5% vs. 17.1% (p=0.66), severe: 0% vs. 0% (p=1.00, ns.)
  • second day: none: 40.5% vs. 35.0% (p=0.62), mild: 35.1% vs. 45. 0% (p=0.38), moderate: 21.6% vs. 20.0% (p=0.86), severe: 2.7% vs. 0% (p=0.48, ns.)
  • third day: none: 37.8% vs. 35.0% (p=0.80), mild: 37.8% vs. 42.5% (p=0.68), moderate: 21.6% vs. 20.0% (p=0. 86), severe: 2.7% vs. 2.5% (p=1.00, ns.)
  • fourth day: none: 32.4% vs. 45.0% (p=0.26), mild: 32.4% vs. 27.5% (p=0.64), moderate: 32.4% vs. 25.0% (p=0.47), severe: 2.7% vs. 2.5% (p=1.00, ns.)
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". NA
Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process ?
Bias due to deviation from intended intervention (assignment to intervention) ?
Bias due to deviation from intended intervention (adhering to intervention) NA
Bias due to missing outcome data ?
Bias in measurement of the outcome ?
Bias in selection of the reported result ?
Other sources of bias ?
Overall RoB judgment ?

Funding and Conflicts of Interest

Funding This work was financially supported by the Baqiyatallah University of Medical Sciences.
Conflicts of Interest The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Further points for assessing the study

Sample

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

Alternative Explanation

Other explanations for an effect besides the investigated intervention ?
- Possibility of attention effects ?
- Possibility of placebo effects ?
- Other reasons ?

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 ?
Correction for multiple testing ?
Measurement of compliance ?
Consistent reporting in numbers (figures, flowchart, abstract, results) ?
Comprehensive and coherent reporting ?
Cross-over ?
- Sufficient washout period ?
- Tested for carry-over effects ?
- Tested for sequence effects ?

Interpretation of results

Effect sizes reported (clinical vs. statistical significance) ?
Side effects systematically recorded ?
Side effects considered in result interpretation ?
Ethics votum ?


Additional Notes

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