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'''Administration of hyperbaric oxygen during radiotherapy for head and neck tumours improved local tumour control and salvage operation rates, but not survival.''' 

{|
| '''Clinical Bottom Line:''' 
|-
| 1. There was no improvement in 5 year survival in the hyperbaric group. 2. There was significant reduction in the number of patients with local recurrence in the hyperbaric group. 3. There was a significant reduction in the number of salvage operations in the hyperbaric group.
|-
|}
'''Appraised by:''' Mike Bennett, Dept of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney; Wednesday, 24 February 1999 

'''Clinical Scenario:''' A patient presenting with an SCC of the floor of the mouth for radiotherapy. We asked if the administration of hyperbaric oxygen during radiotherapy would improve outcome. 
'''Three-part Question:''' In patients with head and neck tumours, does the administration of hyperbaric oxygen during radiotherapy sessions, compared to normal air breathing, result in any improvement in survival or local recurrence? 
'''Search Terms:''' Hyperbaric oxygenation, tumours/head and neck. 

'''The Study:''' 
Non-blinded randomised controlled trial without intention-to-treat. 
Patients with confirmed SCC in the head and neck in whom radiotherapy was the treatment of choice. 
Control group (N = 152; 151 analysed): Radiotherapy to 3,500 rads in 10 fractions over 3 weeks. 
Experimental group (N = 143; 125 analysed): Radiotherapy to the same dose schedule but doses given while breathing oxygen at an unspecified hyperbaric pressure.

'''The Evidence:''' 

{|
| '''Outcome''' || '''Time to Outcome''' || '''Air group''' || '''HBO group''' || '''Relative risk reduction''' || '''Absolute risk reduction''' || '''NNT''' 
|-
| '''survival''' || 5 years || 0.291 || 0.264 || 9% || 0.027 || 37 
|-
| '''95% CI:''' || || || || -27% to 46% || -0.08 to 0.13 || NNT'''8 to INF NNH'''13 to INF 
|-
| '''Recurrence free''' || || .3 || .53 || -77% || -0.230 || -4 
|-
| '''95% CI:''' || || || || -100% to -39% || -0.34 to -0.12 || -9 to -3 
|-
| '''Salvage surgery''' || || 0.305 || 0.128 || 58% || 0.177 || 6 
|-
| '''95% CI:''' || || || || 27% to 89% || 0.08 to 0.27 || 4 to 12 
|-
|}

'''Comments:''' 
1. Large study in this context has reasonable power to detect a clinically significant difference. 
2. HBO seems to save operations but not lives in this ten fractions regime. 
3. There may be little relevance to the current treatment of these tumours. 
4. Those not tolerating HBO (18) were excluded from analysis. 

'''Expiry date:''' July 2020
'''References:''' 
1. Henk JM, Kunkler PB, Smith CW. Radiotherapy and hyperbaric oxygen in head and neck cancer. Final report of first controlled clinical trial. Lancet 1977; 8029:101-103. 
2. Kunkler PB, Boulis-Wassif S, Shah NK, Sutherland WH, Smith C. A controlled trial of hyperbaric oxygen in the radiotherapy of head and neck tumours. Br Journal of Radiology 1968; 41:557. 
3. Henk JM. Overcoming the oxygen effect: hyperbaric oxygen or protracted fractionation. Fifth International Hyperbaric Congress Proceedings II 1974:794-801. 
4. Henk JM. The influence of oxygen and hypoxia on laryngeal cancer management. Laryngoscope 1975; 85:1134-1144.

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Gordoben: Imported from Wikispaces