Lovik 1996.

Study characteristics
Methods	RCT. Parallel design with 2 treatment arms. Duration: 6 weeks. Location: Norway.
Participants	Inclusion criteria: adults who had received radiotherapy for cancers of head and neck. Exclusion criteria: serious liver or kidney disease, other cancers, diseases presumed to affect nutritional status, poor ability to cooperate or poor general condition. Number randomised: 52 participants (intervention group, n = 28; control group, n = 24). Attrition: 3 deaths (group not reported, analysed 49 participants). Gender split: 40 males, 9 females. Age: range 34 ‐ 86 years. Nutritional status: at study entry unclear, 10% reported weight loss and BMI ranged from 18 ‐ 37kg/m².
Interventions	Intervention: participants received dietary advice plus ONS if required in the form of intensive dietary instruction from a dietitian including advice to use nutritional supplements if required. Control: participants received no dietary advice and no ONS in the form of a standard information sheet "for patients receiving radiation therapy for cancer" providing information on all aspects of treatment and including advice to eat a nutritious diet.
Outcomes	Body weight*, BMI, TSF, MAMC, MUAC, energy intake*, survival*, serum chemistry, albumin and transferrin.
Publication details	Language: Norwegian. Funding: Meddinova's Research Fund. Publication status: peer‐reviewed journal.
Notes	Additional data and information on quality obtained from authors.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Details from author, sequence generation using a random number list.
Allocation concealment (selection bias)	Low risk	Sequentially numbered sealed opaque envelopes.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	The study was assumed to be unblinded. However, this is unlikely to influence clinical outcomes.
Blinding (performance bias and detection bias) Functional outcomes	High risk	The study was assumed to be unblinded. Functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	The study was assumed to be 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 because low risk for clinical outcomes and high risk for functional and nutritional outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	3 deaths, group not reported. All participants were analysed.
Selective reporting (reporting bias)	Unclear risk	No study protocol identified, thus unable to judge whether all planned outcomes were reported. Data on change in weight extracted from the paper, but clarification needed for mortality data. Data on TSF, MAMC presented as number of participants with values below 85% of the normal limit and so not included. Data on energy intake is expressed according to expected intake, therefore not usable.
Other bias	Low risk	Baseline variables given, groups similar at baseline.