Evans 1987.
Study characteristics | ||
Methods | RCT. Parallel design with 3 arms. Duration: 12 weeks (all outcomes) and follow‐up between 3 and 5 years for survival. Location: Toronta, Canada |
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Participants |
Inclusion criteria: adults receiving chemotherapy for advanced colorectal and non‐small‐cell lung cancer. Exclusion criteria: obstruction of the superior vena cava, CNS metastases or chronic systemic illness Number randomised: 180 participants, 156 deaths in the 3 study groups. Gender split: 109 males, 71 females. Age: range intervention group 23 ‐ 79 years; control group 33 ‐ 78 years. Nutritional status: more than 5% weight loss at study entry: 46% of participants. |
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Interventions |
Intervention 1: participants (n = 51) received dietary advice plus ONS if required in the form of nutritional counselling to achieve a target caloric intake (using supplements if required). Intervention 2 (n = 60): nutritional counselling to achieve target caloric intake but including 25% of calories as protein (using food and protein supplements) plus a supplement of zinc and magnesium. Control: participants (n = 69) received no dietary advice and no ONS in the form of ad lib food intake. |
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Outcomes | Body weight, energy intake, mortality*, tumour response to chemotherapy. | |
Publication details |
Language: English. Funding: not declared. Publication status: peer‐reviewed journal. |
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Notes | Data from only the first intervention group and the control group (120 participants) will be used: 1. nutritional counselling to achieve target caloric intake 2. ad lib food intake. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed using a central office. Participants were stratified and randomisation blocked. |
Allocation concealment (selection bias) | Low risk | Allocation was concealed by using a central office. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Although not mentioned, the trial was likely unblinded, due to the nature of the intervention. However, this is unlikely to influence clinical outcomes Judged to be unclear because low risk for clinical outcomes and high risk for functional and nutritional outcomes |
Blinding (performance bias and detection bias) Functional outcomes | High risk | We assume the trial was unblinded. Functional outcomes could have been influenced by lack of blinding. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | We assume the trial was unblinded. Nutritional outcomes could have been influenced by lack of blinding. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Follow‐up assessments were performed by the study dietitian either in person or by telephone. We assume this was not blinded and it is likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judged to be unclear because low risk for clinical outcomes and high risk for functional and nutritional outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 156 deaths in the 3 study groups: 88 due to lung cancer and 68 due to colorectal cancer; 94/111 (85%) in both intervention groups combined and 62/69 (90%) in the control group. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. Data presented as median % change and therefore not in a usable format and author unable to supply data. |
Other bias | Low risk | Baseline variables stated, groups similar at baseline. |