ONC: Chemotherapy (2006)
Cancer diagnosed by pathology or cytology
Recruitment :Not described
Design:Subjects were randomized into group A with selenium administration in first chemotherapy cycle as study cases and without selenium in the second cycle of chemotherapy as control. Subjects randomized to Group B had no selenium in the first chemotherapy cycle as control and received selenium in the second chemotherapy cycle as study cases.
Blinding used:Not described
Intervention: 4000 micrograms selenium/day as Seleno-Kappacarrageenan given from 4 before to 4 days after chemotherapy for study cases.
Timing of Measurements
- Serum selenium: 4 days before and 4 days after selenium administration
- Liver Function: SGPT, bilirubin, AKP measured on days 4 and 8 before and post selenium supplementation
- Renal Toxicity:
- BUN and creatinine on days 4 and 8 before and after selenium administration
- Urine enzymes (NAG, GGT, LAP, AAP, ALP) 2, 24, 48, 72 hours before and after chemotherapy
- Hematology: Peripheral WBC, platelet and RBC counts 7,10,14, 20 days before and after chemotherapy.
Dependent Variables
- Selenium-associated side effects of cisplatin: liver and renal toxicity measures
- Bone marrow suppression: peripheral WBC, blood transfusion and consumption of granulocyte colony stimulationg factors
Independent Variables
- Selenium supplementation: serum selenium levels
Initial N: Selenium supplemented group = 41. Group A: 20, first cycle of chemotherapy with selenium administration. Group B: 21, second cycle of chemotherapy. Controls = 41. Group A: 20, without selenium supplementation in second cycle of chemotherapy. Group B: 21, without selenium supplementation in first cycle of chemotherapy.
- Male: female 27:14
Age: 31-72 years
Other relevant demographics:
- Lung cancer 27
- Epidermoid carcinoma 10
- Adenocarcinoma 10
- Gastric carcinoma 2
- Primary liver cancer 2
- Esophagus carcinoma 2
- Colon carcinoma 1
Karnofsy performance status scale for each patients was >60.
Chemotherapy: cisplatin was administered by IV in dosage of 60-80 mg/M2 on day 1 in combination chemotherapy.
Location: Beijing Hospital, Beijing China
Only statistically significant differences are reported here.
Variables |
Treatment Group Measures and confidence intervals |
Control group Measures and confidence intervals |
Statistical Significance of Group Difference |
Renal toxicity Urine NAG 2, 24, 48 hours after chemotherapy Urine GGT 2,24,48 hours after chemotherapy Urine AAP 2,24,48,72 hours after chemotherapy |
9.56+8.71, 9.52+6.85,8.19+5.21
18.88+12.04, 17.18+8.42, 18.89+7.92 13.94+8.08, 14.65+11.79, 13.43+8.59,13.39+9.54 |
16.24+7.33, 13.59+6.58, 13.10+9.86 41.38+21.30, 27.24+12.72, 23.59+10.51 24.05+13.69, 24.25+14.52, 18.92+10.09,20.77+14.32 |
P<0.005, <0.05, <0.01
P<0.05, <0.001, <0.02 P<0.001, <0.01, <0.02, <0.05 |
Bone marrow suppression: Peripheral WBC, day 14 Blood transfusion, average volume (mL) Consumption of granulocyte colony stimulating factor (IU) |
3.35+2.01
0 110+82 |
2.31+1.38
62 +38 723+192 |
P<0.05
P<0.05 P<0.05 |
Government: | Ministry of Public Health (China) |
Quality Criteria Checklist: Primary Research
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Relevance Questions | |||
1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | Yes | |
2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | Yes | |
4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | Yes | |
Validity Questions | |||
1. | Was the research question clearly stated? | Yes | |
1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | Yes | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
2. | Was the selection of study subjects/patients free from bias? | ??? | |
2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | Yes | |
2.2. | Were criteria applied equally to all study groups? | Yes | |
2.3. | Were health, demographics, and other characteristics of subjects described? | Yes | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | Yes | |
3. | Were study groups comparable? | N/A | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | No | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | Yes | |
3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | Yes | |
3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | N/A | |
3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | N/A | |
3.6. | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? | N/A | |
4. | Was method of handling withdrawals described? | N/A | |
4.1. | Were follow-up methods described and the same for all groups? | N/A | |
4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | N/A | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | N/A | |
4.4. | Were reasons for withdrawals similar across groups? | N/A | |
4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | N/A | |
5. | Was blinding used to prevent introduction of bias? | ??? | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | ??? | |
5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | ??? | |
5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | N/A | |
5.4. | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? | N/A | |
5.5. | In diagnostic study, were test results blinded to patient history and other test results? | N/A | |
6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | Yes | |
6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | Yes | |
6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | N/A | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | Yes | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | Yes | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | Yes | |
6.6. | Were extra or unplanned treatments described? | N/A | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | N/A | |
6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
7. | Were outcomes clearly defined and the measurements valid and reliable? | Yes | |
7.1. | Were primary and secondary endpoints described and relevant to the question? | N/A | |
7.2. | Were nutrition measures appropriate to question and outcomes of concern? | N/A | |
7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | Yes | |
7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | Yes | |
7.5. | Was the measurement of effect at an appropriate level of precision? | Yes | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | ??? | |
7.7. | Were the measurements conducted consistently across groups? | Yes | |
8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | Yes | |
8.1. | Were statistical analyses adequately described and the results reported appropriately? | Yes | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | Yes | |
8.3. | Were statistics reported with levels of significance and/or confidence intervals? | Yes | |
8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | N/A | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | N/A | |
8.6. | Was clinical significance as well as statistical significance reported? | Yes | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
9.1. | Is there a discussion of findings? | Yes | |
9.2. | Are biases and study limitations identified and discussed? | N/A | |
10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |