Uster 2013.

Study characteristics
Methods	RCT. Parallel design with 2 arms. Duration: 3 months. Location: Switzerland.
Participants	Inclusion criteria: adult cancer outpatients, undernourished or at high risk for undernutrition by the NRS 2002 tool. Exclusion criteria: estimated survival < 6 months (as judged by the treating physician), on enteral tube feeding or parenteral nutrition, ongoing nutritional counselling or interventions (e.g. intake of oral nutritional supplements), adjuvant chemotherapy, impaired cognition and inability to give consent. Number randomised: 58 participants (intervention group, n = 30; control group, n = 28). Attrition n = 29 (intervention group, n = 15; control group, n = 14). Gender split: 46 males, 12 females. Age: mean (SD), intervention group 66.2 (8.9) years; control group 63.8 (13.3) years. Nutritional status: mean (SD) BMI, intervention group 23.1 (2.4) kg/m2, control group 22.6 (2.8) kg/m2.
Interventions	Intervention: participants received dietary advice plus ONS if required in the form ofstandardized individual nutritional therapy, including counselling by a dietitian, food fortification, and oral nutritional supplements if required. Control: participants received no dietary advice and no ONS in the form of standard care without specific nutritional intervention or fixed prescription of oral nutritional supplements; if participants had questions concerning nutrition, they were advised by the cancer centre's attending physician or the nurses but not by professional dietitians.
Outcomes	Dietary intake (3‐day dietary record)*, nutritional status (body weight)*, physical functioning* (performance status, handgrip strength) and QoL (EORTC‐C30)*.
Publication details	Language: English. Funding: grant from the Krebsliga Schweiz (Swiss Cancer Foundation), Nestle Healthcare Medical Nutrition (Vevey, Switzerland) contributed to the funding of the study. Publication status: peer‐reviewed journal.
Notes	The authors provided additional change scores for weight, energy intake, protein and handgrip strength. Additional change scores for QoL not available at the moment but will become available later, therefore final scores and SD for QoL read from the graphs. Due to a low recruitment of patients, the study was terminated after 2.5 years. A sample size of 200 participants (100 per arm) was calculated, 67 participants were included.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	The description of the study strongly suggests it was unblinded and that both participants and the treating dietitian were aware of group allocation. Unclear who performed the clinical or functional outcome measures. However, knowing group allocation is unlikely to influence clinical outcomes.
Blinding (performance bias and detection bias) Functional outcomes	High risk	The study was unblinded. Functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	The study was unblinded. Nutritional outcomes could have been influenced by lack of blinding.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not described and 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, as low risk for clinical outcomes and high risk for nutritional outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Due to a low recruitment of participants, the study was terminated after 2.5 years. A sample size of 200 participants (100 per arm) was calculated, 67 participants were included. Attrition n = 29 (intervention group n = 15; control group n = 14), 16 (8 in each group) of these participants died.
Selective reporting (reporting bias)	Unclear risk	No study protocol identified, thus unable to judge whether all planned outcomes were reported.
Other bias	Unclear risk	The tumour types were comparable in the two groups, except for head and neck cancer, which happened to be randomised only the intervention group. The performance status in the intervention group was significantly lower than in the usual care group.