Grötz 2001.
| Methods | Location: Germany Number of centres: 1 Date of randomisation: not stated |
|
| Participants | Inclusion criteria: scheduled to receive adjuvant or sole radiotherapy for head and neck cancer to a scheduled dose of 60 Gy. Cranial border of the field above the chin‐mastoid line so salivary glands are located in the core irradiation field Exclusion criteria: salivary gland disorders Age: mean age = 55 years Gender: 22 M, 1 F Cancer type: head and neck Radiotherapy: total dose = 60 Gy Chemotherapy: unclear Number randomised: 48 Number evaluated: 23 |
|
| Interventions |
Coumarin + troxerutin versus placebo Venalot Depot (coumarin 15 mg and troxerutin 90 mg) tablet: 2 tablets 3 times daily. Start 1 week before RT and 4 weeks after end of RT Control: placebo |
|
| Outcomes | Xerostomia: not reported, only as part of total RTOG Salivary flow rates: stimulated and unstimulated using sialoscintigraphy (sialometry abandoned as primary marker as not successfully collected). Acute radiation side effects RTOG score but for all organs Adverse effects: reddened skin, nausea Survival data: locoregional control Other oral symptoms: not reported Other oral signs: not reported Quality of life: not reported Patient satisfaction: not reported Cost data: not reported Timing of assessment: 4 weeks after RT |
|
| Funding | Not stated | |
| Trial registration | Unclear | |
| Sample size calculation presented | Not reported | |
| Notes | Unable to use data | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding (performance bias and detection bias) patients/carers | Low risk | Venalot Depot versus placebo |
| Blinding (performance bias and detection bias) outcome assessment | Low risk | Salivary flow rates objective outcome |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 48 randomised, 25 dropped out. Dropouts per group not specified |
| Selective reporting (reporting bias) | High risk | Xerostomia not reported. Data for total RTOG score presented but no break down by condition or organ |
| Other bias | Low risk | No other sources of bias are apparent |