Skip to main content
. 2012 Apr 18;2012(4):CD005007. doi: 10.1002/14651858.CD005007.pub3

Tobin 1971

Methods RCT with randomisation by card drawn by an individual not involved with the study. Allocation probably made in a concealed manner after randomisation. Patient, outcome assessors and treating team all aware of allocation after trial started. No indication of power calculation. Several different tumours studied: head and neck, uterine cervix, urinary bladder, rectal, brain and oesophagus
Participants
  • Group 1: 17 adults with carcinoma of the head and neck, 9 allocated to HBOT and 8 to control

  • Group 2: 14 adults with carcinoma of the uterine cervix, 7 allocated to both HBOT and control

  • Group 3. 6 adults with carcinoma of the urinary bladder, 3 allocated to each of HBOT and control

  • Group 4. 4 adults with carcinoma of the rectum, 2 allocated to each of HBOT and control

  • Group 5. 4 adults with glioblastoma of the brain, 2 allocated to each of HBOT and control

  • Group 6. 4 adults with carcinoma of the oesophagus, 2 allocated to each of HBOT and control


A further three patients allocated to HBOT were incomplete when trial ceased and have not been analysed
Interventions
  • Control: exact dose and fractionation schedules not given, but 'normal fractionation implies 24 to 30 fractions over six weeks approximately and varied with tumour site

  • HBOT: same regimen, conducted at 3 ATA breathing 100% oxygen, total compression time about 50 minutes

Outcomes Death at 1 and 2 years
Notes Trial terminated after explosive decompression of the chamber due to degradation of chamber wall from radiation Schulz rating: randomisation: B; allocation concealment: A; selection bias: A; blinding: C
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate