Shukla 2010.

Study characteristics
Methods	Design: RCT Country: India Accrual dates: July 2006 to June 2008 Trial Reg.: NR Funding source: NR
Participants	No. randomised: 252 (229 analysed) Inclusion criteria: histologically‐confirmed nonmetastatic carcinoma of the cervix with Karnofsky performance status of 70% or above and stage IIB ‐ IIIB Exclusion criteria: any intestinal pathology that might interfere with primary end point assessment and those who smoked during the treatment Gender: Female Age mean: Intervention about 49 years, Control about 50 years Type of cancer: Cervix Radiotherapy regimen received: All participants had external radiation to the whole pelvis using anterior and posterior parallel opposing fields to a dose of 50Gy in 25 fractions at 5 fractions/wk Primary/adjuvant/other: Primary Other treatment received: Intracavitary brachytherapy; participants were given symptomatic treatment such as antimotility drugs and intravenous fluids as and when required
Interventions	Comparison: Evening vs morning RT Arm 1: Evening RT (6pm to 8pm) Arm 2: Morning RT (8am to 10 am)
Outcomes	GI Toxicity: acute (RTOG) QoL: NR Other review outcomes: NR Other study outcomes: Tumour response, other toxicity Duration of follow‐up: NR; weekly follow‐up during treatment
Notes	Baseline characteristics were comparable between groups including age, tumour stage and grade, haemoglobin levels and Karnofsky performance status. The overall treatment time for Group A was 36.33 days and for Group B was 35.64 days. The overall radiotherapy‐induced mucositis (grades I ‐ IV) in participants of the 2 groups was found to be significantly higher in the morning arm (P < .01). Other radiation‐induced toxicity was also higher in the morning arm, but its occurrence in the 2 arms did not differ significantly (13.45% vs 12.73%, P > .05). 23 participants were excluded after randomisation: 8 due to non‐treatment‐related reasons and 15 due to non‐mucositis‐related reasons, such as leucopenia (haematological complications). Judging from the numbers in each group, more participants in the evening group were excluded than in the morning group, which could have biased the results (particularly those on haematological toxicity) We tried to contact the authors for clarification of reasons for withdrawal in each group but were unsuccessful
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer generated random numbers"
Allocation concealment (selection bias)	Unclear risk	Insufficient detail to make a judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not stated, but interventions cannot be blinded
Blinding of outcome assessment	Unclear risk	Insufficient detail to make a judgement
Incomplete outcome data (attrition bias) All outcomes	High risk	Out of 23 excluded patients, 8 did not complete treatment because of reasons other than treatment‐related problems, and 15 had radiation interrupted during the treatment because of complications developed other than mucositis. Judging from the numbers in each group, more participants in the evening group were excluded than in the morning group. This could have biased the results
Selective reporting (reporting bias)	Low risk	Protocol not seen, but methods and expected outcomes were clearly reported
Other bias	Low risk	None noted; baseline characteristics were similar
Overall judgement	High risk	Significant methodological limitations introduced by post‐randomisation exclusions