Bourdel‐Marchasson 2014.

Study characteristics
Methods	RCT. Parallel design with 2 arms. Duration: interviews were performed 6 times during the chemotherapy sessions for 3 to 6 months with two‐year follow‐up. Location: multicentre in France.
Participants	Inclusion criteria: aged 70 years or older and being treated with chemotherapy for solid tumour, at risk of malnutrition (MNA < 17 or > 23.5). Exclusion criteria: Karnofsky index < 50%, under chemotherapy process. Number randomised: 336 participants (randomised 341, dropouts 5). Gender split: 51% males, 49% females. Age: mean (SD), intervention group 77.7 (5.2) years; control group 78.3 (4.7) years. Nutritional status: all at risk of malnutrition (MNA < 17 or > 23.5
Interventions	Intervention: participants received dietary advice plus ONS if required in the form of dietary counselling (face‐to‐face discussion targeting the main nutritional symptoms) to achieve an energy intake of 30 kcal/kg body weight/day and 1.2 g protein/kg/day. Control: participants received no dietary advice and no ONS in the form of usual nutritional care routinely given in the cancer treatment settings with no restrictions for dietary advice, oral supplements or prescription of artificial nutrition.
Outcomes	Primary outcome: 1‐year mortality. Secondary outcomes: 2‐year mortality, toxicities and chemotherapy outcomes, weight change, nutritional intake, prescription of enteral and parenteral nutrition, hospitalisation for reasons other than chemotherapy, QoL (EORTC‐C30) , MNA, ADL, IADL, MMS and GDS.
Publication details	Language: English. Funding: supported by the National Hospital Program of Clinical Research (Programme Hospitalier de Recherche Clinique 2006) (46%), La Ligue contre le cancer (52%) and AMGEN (2%) and sponsored by the university hospital of Bordeaux (CHU Bordeaux). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publication status: peer‐reviewed journal.
Notes	Quote: "The trial was stopped before completion of the planned inclusions. However, it is unlikely that the lack of an observed effect of intervention is due to lack of power. In the whole sample, a trend of an increase in two‐year mortality in the intervention group was seen. However, even if we had reached the planned sample size, such mortality rates in both arms would not have provided a significant difference in survival. This absence of effect on mortality and other outcomes was not due to unbalanced characteristics of patients between groups according to cancer disease, chemotherapy or nutritional baseline assessment."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation list was prepared by the clinical trial unit biostatistician. Randomization was centralized by internet, with a 1:1 ratio, stratified by recruitment centre.
Allocation concealment (selection bias)	Low risk	Randomisation was centralized by internet and the randomization list stored by the clinical trial unit biostatistician.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	The trial was unblinded. However, this is unlikely to influence clinical outcomes.
Blinding (performance bias and detection bias) Functional outcomes	High risk	The trial was unblinded. Functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	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	None of the staff in cancer treatment centres were aware of the content of the nutritional intervention. Patients were unblinded to group assignment. 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	341 were randomised, 336 were analyzed. Attrition n = 5 (less than 1%) (1 consent withdrawal, 4 with exclusion criteria) all in the control group.
Selective reporting (reporting bias)	Unclear risk	Protocol identified Clinicaltrials NCT00459589. Some secondary outcomes not reported (function, QoL, MNA and some biochemical outcomes).
Other bias	Low risk	Baseline characteristics presented and groups were similar. Study was stopped early. However, it is unlikely that the lack of an observed effect of intervention is due to lack of power.