Isenring 2004.
| Methods | Randomised controlled trial. Duration 12 weeks. | |
| Participants | Adults (n = 60, 51 men and 9 women, mean age (SD) 61.9 years (14)) receiving radiotherapy for cancers of head & neck (88%) or abdomen (12%). At baseline 65% of participants were well‐nourished and 35 % malnourished (PG‐SGA). 6 participants were lost to follow up, 4 from the dietary advice and supplement group, 5 participants from no advice group requested referral to a dietitian. |
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| Interventions | Individualised intensive nutritional counselling and nutritional supplements if appropriate (n = 29) versus standard nutrition booklet and participants could request referral to a dietitian (n = 31). | |
| Outcomes | Survival*, weight*, grip strength*, fat free mass (BIA), QOL, change in PG‐SGA score, energy intake*. | |
| 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 provided by the author, a random number table. |
| Allocation concealment (selection bias) | Low risk | Details provided by the author, sealed opaque envelopes. |
| Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | Not stated. |
| Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not stated. |
| Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not stated. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 6 participants were lost to follow up, details not given in the paper but provided by the author on request. 4 deaths (2 in the intervention group and 2 in the control group) and 2 others lost to follow up in the intervention group (1 as a result of deterioration in condition and 1 because patient discontinued treatment and withdrew from the study). |
| Selective reporting (reporting bias) | Low risk | All specified outcomes reported in text and figures but not in a format usable for meta‐analysis. Data on mortality and mean change (SD) for weight and energy intake obtained from authors. |
| Other bias | Low risk | Baseline variables given, groups similar at baseline. |