Veerasarn 2006.

Methods	Location: Thailand Number of centres: 5 Date of recruitment: February 1999 to September 2001
Participants	Inclusion criteria: histological proven squamous cell carcinoma of head and neck region; ECOG performance statue 0‐2; adequate bone marrow, liver and renal functions; age 18‐70 years; no prior definite/radical surgery, chemotherapy, radiotherapy or biological response modifier; no evidence of distant metastasis; life expectancy ≥ 12 months; able to comply with a follow‐up schedule; weight loss ≤ 10% in previous 3 months Exclusion criteria: concomitant malignant disease in other parts of the body; active uncontrolled infection; pregnant or lactating women; medical or psychiatric illness that compromise the patient's ability to complete the study; concomitant use of chemotherapy Age: amifostine: mean 55 (23‐70); control: mean 52 (23 to 69) Gender: amifostine: 24 M, 8 F; control: 27 M, 8 F Cancer type: oral cavity, oropharynx, nasopharynx, larynx, hypopharynx Radiotherapy: standard fractionation (2 Gy, 5 days a week). Duration: 5 to 8 weeks. Definite RT = 70 Gy. Postoperative RT = 50 Gy. Amifostine group: definite RT = 15; postoperative RT = 17. Control group: definite RT = 18; postoperative RT = 17 Chemotherapy: none Number randomised: 67 (amifostine 32, control 35) Number evaluated: 62 (amifostine 32, control 30)
Interventions	Amifostine versus no intervention Amifostine: (Ethyol) (200 mg/m²) IV (3 to 5 min), 30 min before RT. 5 consecutive days a week for 5 to 7 weeks (during RT) Control: nothing
Outcomes	Xerostomia: 1) questionnaire (6 questions) (RTOG/EORTC acute and late radiation morbidity scoring criteria) for xerostomia: dryness of mouth, oral comfort, quality of sleep, ability to speak, ability to chew and swallow and ability to wear dentures (average score 0 to 10: 0 = normal); 2) RTOG 0 to 4 scale ‐ grade 2 and above Salivary flow rates: unstimulated and stimulated whole saliva collection (mg/5 min) and scintigraphy Adverse effects: nausea, vomiting, hypotension Survival data: disease‐free survival Other oral symptoms: mucositis (RTOG grade 2‐3) Other oral signs: not reported Quality of life: not reported Patient satisfaction: not reported Cost data: not reported Timing of assessments: weekly during RT (for 6 weeks), then at end of RT and at 1, 2, 3, 6, 12, 18 and 24 months after RT; survival at 24 months after RT
Funding	Source of funding: unclear
Trial registration	Not registered or published
Sample size calculation presented	No
Notes	Information on randomisation, and numbers and SDs from correspondence
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding (performance bias and detection bias) patients/carers	High risk	Amifostine versus no intervention
Blinding (performance bias and detection bias) outcome assessment	High risk	Xerostomia is subjective measure
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "We excluded 5 cases in the control as they did not have salivary gland function, or had severe salivary gland impairment" Comment: we are assuming that there were no other dropouts (assessment made on 32 in amifostine, 30 in control)
Selective reporting (reporting bias)	Low risk	Xerostomia and adverse events reported
Other bias	Low risk	No other sources of bias are apparent