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Barton et al. (2013): The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9

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Title The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer
Topic Ginkgo
Author Barton, DL, Burger, K, Novotny, PJ, Fitch, TR, Kohli, S, Soori, G, Wilwerding, MB, Sloan, JA, Kottschade, L.A, Rowland, KM, Dakhil, SR, Nikcevich, DA, Loprinzi, CL
Year 2013
Journal Support Care Cancer
DOI https://doi.org/10.1007/s00520-012-1647-9

Study Note

Brief summary

Patients receiving chemotherapy often describe a decline in cognitive function (known as "chemo brain") that remains for months or years after chemotherapy has ended. As breast cancer survival rates improve, more attention is being paid to this side effect on patients' daily functioning. Women newly diagnosed with breast cancer were given either capsules containing Ginkgo biloba extract (GBE) at a dose of 120 mg per day or a placebo. In this study, the researchers found no benefit from taking GBE at this dose to prevent chemotherapy-induced cognitive decline in women with breast cancer.

Patienten, die eine Chemotherapie erhalten, beschreiben oft eine Abnahme der kognitiven Funktion (sog. "Chemo-Brain"), dass über Monate oder Jahre nach Beendigung der Chemotherapie bleibt. Mit der Verbesserung der Überlebensrate von Brustkrebs wird diesem Nebeneffekt auf das tägliche Funktionieren der Patienten mehr Beachtung geschenkt. Frauen, bei denen Brustkrebs neu diagnostiziert wurde, erhielt entweder Kapseln mit Ginkgo biloba-Extrakt (GBE) in einer Dosis von 120 mg pro Tag oder ein Placebo. In dieser Studie fanden die Forscher keinen Nutzen aus der Einnahme von GBE in dieser Dosierung, um einen chemotherapeutisch bedingten kognitiven Rückgang bei Frauen mit Brustkrebs vorzubeugen.

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 Multicentric
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 Double
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 Newly diagnosed; chemotherapy; chemo-naive
Exclusion criteria Use of Ginkgo biloba in the last 6 months; antithrombotic therapy; significant concomitant diseases, e.g. diabetes
N randomized 226
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 NA
Countries of data collection United States
LoE Level of evidence 1b Oxford 2009
Outcome timeline Data collection times Baseline (before first or second cycle of chemotherapy), during chemotherapy, at the first visit postchemotherapy (generally 1 month after chemotherapy and commensurate with the completion of the study agent), and at 6, 12, 18, and 24 months after chemotherapy. Potential side effects were evaluated at each data point.

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. 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 Lymph node involvement

0–3 intervention arm: 93 (87 %), placebo arm: 89 (86 %) ≥4 intervention arm: 14 (13 %), placebo arm: 14 (14 %)

Comorbidities Intervention/ placebo arm:

Menopausal status Premenopausal 55 (51 %)/ 56 (54 %) Postmenopausal 44 (41 %)/ 43 (42 %) Unknown 8 (8 %)/ 4 (4 %)

Current cancer therapies Chemotherapy, Hormone therapy
Specifications on cancer therapies All patients chemotherapy (Intervention/ placebo arm):

Doxorubicin/cyclophosphamide 35 (33 %)/ 37 (36 %) Doxorubicin/cyclophosphamide/taxane 56 (52 %)/ 54 (52 %) Other anthracycline-based chemo 6 (6 %)/ 0 (0 %) Other nonanthracycline-based chemo 10 (9 %)/ 12 (12 %)

Adjuvant Tamoxifen therapy planned (intervention/ placebo arm): Yes 55 (51 %)/ 56 (54 %) No 52 (49 %)/ 47 (46 %)

Previous cancer therapies NI
Gender Female
Gender specifications 100% female
Age groups Adults (18+)
Age groups specification Age (years): <50 = 50%; ≥50 = 50%

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 107
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date 23
Drop-out reasons Withdrew for personal reasons n=18

Adverse Events n=5

Intervention Ginkgo biloba
Dosage and regime 60mg; 2x daily (daily dose 120mg)
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 Change in side effects of chemotherapy (scale 0-10), sign. reduction of nausea within the Ginkgo arm (Mean=-0.1, SD=2.78) compared to the placebo arm (Mean=-0.9, SD=2.67), p=0.05
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 103
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date 20
Drop-out reasons Withdrew for personal reasons n=15

Adverse Events n=5

Intervention Placebo
Dosage and regime 2x daily
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 NI

Outcomes

Cognitive functioning

Outcome type As specificed by the authors Primary
Outcome specification Objective
Type of measurement HSCS (High Sensitivity Cognitive Screen), TMT (Trail Making Test)
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". No difference between arms.
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". No difference between arms.
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 ?

Cognitive functioning

Outcome type As specificed by the authors Secondary
Outcome specification Subjective
Type of measurement Atomic absorption, PHS (Cognitive subscale of the Perceived Health Scale), POMS (Profile of Mood States)
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". No difference between arms.
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". No difference between arms.
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 ?

Toxicity

Outcome type As specificed by the authors Secondary
Outcome specification NA
Type of measurement NCI-CTC v.2 (National Cancer Institute-Common Toxic Criteria)
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". No difference between arms.
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". No difference between arms.
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 Public Health Service grants
Conflicts of Interest According to authors none.

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
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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