Difference between revisions of "Teguh"

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==<span style="font-size: 12pt;">Pre-emptive treatment with hyperbaric oxygen following radiation therapy for head and neck cancer may prevent the onset of late radiation tissue injury. </span>==  
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== <span style="font-size:x-large;">'''Pre-emptive treatment with hyperbaric oxygen following radiation therapy for head and neck cancer may prevent the onset of late radiation tissue injury.'''</span> ==
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{|  
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| '''<span style'''"font-size: 10pt;">Clinical bottom line:</span>'''<br><span style'''"font-size: 10pt;">1. Early treatment with HBOT was associated with improved Quality of Life scores for a wide range of symptoms including dry mouth, swallowing difficulties and pain in the mouth</span><br><span style="font-size: 10pt;">2. Early treatment with prophylactic HBOT may prevent the onset of late radiation tissue injury.</span>
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{|
 
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| <span style="font-size:large;">'''Clinical bottom line:'''</span><br/> <span style="font-size:medium;">1. Early treatment with HBOT was associated with improved Quality of Life scores for a wide range of symptoms including dry mouth, swallowing difficulties and pain in the mouth<br/> 2. Early treatment with prophylactic HBOT may prevent the onset of late radiation tissue injury.</span>
 
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**<span style="font-size: 10pt;">Citation:</span>'''<span style="font-size: 10pt;">Teguh DN, Levendag PC, Noever I, Voet P, van der Est H, van Rooij P, Dumans AG, de Boer MF, van der Huls MPC, Sterk W, Schmitz PIM. Early hyperbaric oxygen therapy for reducing radiotherapy side effects: early results of a randomised trial in oropharyngeal and nasopharyngeal cancer. Int J Radiation Oncology 2009; 75(3):711-716. </span>
 
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<span style="font-size: 10pt;">'''Corresponding author name and Email:''' Peter Levendag, [[mailto:p.levendag@erasmusmc.nl | p.levendag@erasmusmc.nl]] </span>
 
  
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**<span style="font-size: 10pt;">Three-part Clinical Question:</span>'''<span style="font-size: 10pt;"> For patients who have received radiation therapy for head and neck malignancies, does early treatment with hyperbaric oxygen, versus no specific treatment, prevent late radiation tissue injury?</span>
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'''<span style="font-size:larger;">Citation:&nbsp;</span>'''<span style="font-size:medium;">Teguh DN, Levendag PC, Noever I, Voet P, van der Est H, van Rooij P, Dumans AG, de Boer MF, van der Huls MPC, Sterk W, Schmitz PIM. Early hyperbaric oxygen therapy for reducing radiotherapy side effects: early results of a randomised trial in oropharyngeal and nasopharyngeal cancer. Int J Radiation Oncology 2009; 75(3):711-716.</span>
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**<span style="font-size: 10pt;">Search Terms:</span>'''<span style="font-size: 10pt;"> radiation tissue injury, xerostomia, head and neck cancer </span>
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**<span style="font-size: 10pt;">The Study: </span>'''<span style="font-size: 10pt;">Non-blinded randomised controlled trial with intention-to-treat. '''A'''dult patients diagnosed with oropharyngeal or nasopharyngeal cancer and treated with radiotherapy (46 to 70 Gy). </span>
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<span style="font-size: 10pt;"><span style="font-size:larger;">'''Corresponding author name and Email:'''</span> <span style="font-size:larger;">Peter Levendag, [[mailto:p.levendag@erasmusmc.nl| p.levendag@erasmusmc.n]</span></span>
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<span style="font-size: 10pt;">CONTROL GROUP (N = 11; analysed): No specific therapy </span>
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<span style="font-size: 10pt; line-height: 1.5;">EXPERIMENTAL GROUP (N = 8; analysed): 100% oxygen breathing at 2.5 ATA for 90 minutes daily, five days per week to a total of 30 treatments starting within two days after completion of radiotherapy.</span>
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<span style="font-size:larger;">'''Three-part Clinical Question:'''</span><span style="font-size: 10pt;"><span style="font-size:larger;">For patients who have received radiation therapy for head and neck malignancies, does early treatment with hyperbaric oxygen, versus no specific treatment, prevent late radiation tissue injury?</span></span>
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<span style="font-size:larger;">'''Search Terms:'''</span><span style="font-size: 10pt;"><span style="font-size:larger;">radiation tissue injury, xerostomia, head and neck cancer</span></span>
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<span style="font-size: 10pt;"><span style="font-size:larger;">'''The Study:'''</span> <span style="font-size:larger;">Non-blinded randomised controlled trial with intention-to-treat.</span></span><span style="font-size:larger;">Adult patients diagnosed with oropharyngeal or nasopharyngeal cancer and treated with radiotherapy (46 to 70 Gy).</span>
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<span style="font-size: 10pt;"><span style="font-size:larger;">'''Control group:'''</span> (N = 11; analysed): No specific therapy</span>
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<span style="font-size: 10pt; line-height: 1.5;"><span style="font-size:larger;">'''Experimental group: '''(N = 8; analysed): 100% oxygen breathing at 2.5 ATA for 90 minutes daily, five days per week to a total of 30 treatments starting within two days after completion of radiotherapy.</span></span>
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'''<span style="font-size:larger;">​​​​​​​The Evidence:</span>'''
  
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**<span style="font-size: 10pt;">The Evidence:</span>'''
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{| class="Table" style="border: 1pt solid windowtext; width: 491px;"
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{|  
 
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| '''<span style'''"font-size: 10pt;">Outcome at </span>'''<span style'''"font-size: 10pt;">12 months</span>''' || <span style'''"display: block; text-align: center;">'''Control group'''</span><span style'''"display: block; text-align: center;">'''Mean'''</span> || <span style'''"display: block; text-align: center;">'''HBOT group'''</span><span style'''"display: block; text-align: center;">'''Mean'''</span> || <span style="display: block; text-align: center;">'''P-value'''</span>
 
 
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| '''<span style="font-size: 10pt;">EORTC H&N35</span>''' ||  ||  || 
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Outcome at</span></span>''''''<span style="font-size:12.0pt"><span style="font-family:">12 months</span></span>'''</span></p>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Control group</span></span>'''</span></p> <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Mean</span></span>'''</span></p>
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| '''<span style'''"font-size: 10pt;">Dry mouth</span>''' || <span style'''"display: block; text-align: center;">90</span> || <span style'''"display: block; text-align: center;">30</span> || <span style'''"display: block; text-align: center;">0.009</span>  
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| style="border: 1pt solid windowtext; width: 115px;" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">HBOT group</span></span>'''</span></p> <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Mean</span></span>'''</span></p>
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| style="border: 1pt solid windowtext; width: 88px;" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">P-value</span></span>'''</span></p>  
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| '''<span style'''"font-size: 10pt;">Swallowing</span>''' || <span style'''"display: block; text-align: center;">40</span> || <span style'''"display: block; text-align: center;">7</span> || <span style'''"display: block; text-align: center;">0.011</span>  
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| style="border:solid windowtext 1.0pt" |
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| '''VAS'''<br>**Pain in mouth''' || <span style'''"display: block; text-align: center;">7</span> || <span style'''"display: block; text-align: center;">1</span> || <span style="display: block; text-align: center;"><0.001</span>  
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<span style="line-height:normal"><span style="height:42.7pt">'''<span style="font-size:10.0pt"><span style="font-family:">EORTC H&N35:</span></span>'''</span></span>
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<span style="line-height:normal"><span style="height:42.7pt">'''<span style="font-size:12.0pt"><span style="font-family:">Dry mouth</span></span>'''</span></span>
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<span style="line-height:normal"><span style="height:42.7pt">'''<span style="font-size:12.0pt"><span style="font-family:">Swallowing</span></span>'''</span></span>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:42.7pt"><span style="font-size:12.0pt"><span style="font-family:">90</span></span></span></span></p> <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:42.7pt"><span style="font-size:12.0pt"><span style="font-family:">40</span></span></span></span></p>
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| style="border: 1pt solid windowtext; width: 115px;" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:42.7pt"><span style="font-size:12.0pt"><span style="font-family:">30</span></span></span></span></p> <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:42.7pt"><span style="font-size:12.0pt"><span style="font-family:">7</span></span></span></span></p>
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| style="border: 1pt solid windowtext; width: 88px;" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:42.7pt"><span style="font-size:12.0pt"><span style="font-family:">0.009</span></span></span></span></p> <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="height:42.7pt"><span style="font-size:12.0pt"><span style="font-family:">0.011</span></span></span></span></p>  
 
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| style="border:solid windowtext 1.0pt" |
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<span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">VAS (</span></span>'''<span style="font-size:12.0pt"><span style="font-family:">Pain in mouth)</span></span></span>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">7</span></span></span></p>
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| style="border: 1pt solid windowtext; width: 115px;" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">1</span></span></span></p>
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| style="border: 1pt solid windowtext; width: 88px;" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:"><0.001</span></span></span></p>
 
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<span style="font-size: 10pt; line-height: 1.5;">1. EORTC H&N35: European Organization for Research and Treatment of Cancer Quality of Life assessment tool for head and neck symptoms, 0 = no symptoms, 100 = worst imaginable symptoms; 2. VAS: Visual Analogue Scale, 0 = no pain, 10 = maximal pain imaginable.</span>
 
  
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**<span style="font-size: 10pt;">Comments:</span>'''
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&nbsp; <span style="font-size: 10pt; line-height: 1.5;">'''EORTC H&N35:''' European Organization for Research and Treatment of Cancer Quality of Life assessment tool for head and neck symptoms, 0 = no symptoms, 100 = worst imaginable symptoms;</span>
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<span style="font-size: 10pt; line-height: 1.5;">1. Very small trial because of slow recruitment rate, and may be subject to considerable bias. In particular, the baseline QoL scores were generally worse in the control group and may explain the observed differences at follow-up.</span>
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<span style="font-size: 10pt; line-height: 1.5;">2. All outcomes are self-reported in non-blinded subjects.</span>
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<span style="font-size: 10pt; line-height: 1.5;">'''VAS: '''Visual Analogue Scale, 0 = no pain, 10 = maximal pain imaginable.</span>
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<span style="font-size: 10pt;">3. No sham treatment given. Authors state that this is unlike to bias the late treatment effect seen at 18 month follow up. </span>
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<span style="font-size: 10pt;">4. All results given in graphic format and p-values are from regression analysis based on maximum likelihood estimation using Stata 9 software.</span>
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​​​​​​​<span style="font-size:larger;">'''Comments:'''</span>
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<span style="font-size:larger;"><span style="line-height: 1.5;">1. Very small trial because of slow recruitment rate, and may be subject to considerable bias. In particular, the baseline QoL scores were generally worse in the control group and may explain the observed differences at follow-up.</span></span>
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<span style="font-size:larger;"><span style="line-height: 1.5;">2. All outcomes are self-reported in non-blinded subjects.</span></span>
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<span style="font-size:larger;">3. No sham treatment given. Authors state that this is unlike to bias the late treatment effect seen at 18 month follow up.</span>
 +
 
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<span style="font-size:larger;">4. All results given in graphic format and p-values are from regression analysis based on maximum likelihood estimation using Stata 9 software.</span>
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<span style="font-size:larger;">'''Appraised by:''' Danielle Wood and Michael Bennett, Prince of Wales Hospital; Saturday, 16 April 2016</span>
  
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**<span style="font-size: 10pt;">Appraised by:</span>'''<span style="font-size: 10pt;"> ''Danielle Wood and Michael Bennett, Prince of Wales Hospital''; Saturday, 16 April 2016</span>
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<span style="font-size:larger;">'''<span style="line-height: 1.5;">Email:''&nbsp;''</span>'''<span style="line-height: 1.5;">danspace@gmail.com</span></span>
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**<span style="font-size: 10pt; line-height: 1.5;">Email:</span>'''<span style="font-size: 10pt; line-height: 1.5;"> danspace@gmail.com</span>
 
  
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[[File:sumhorsa.gif|center]]
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[[File:Sumhorsa.gif|center|Sumhorsa.gif]]
  
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<span style="display: block; text-align: center;">[[Radiation tissue injury | BACK]]</span>
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<span style="display: block; text-align: center;"><span style="font-size:x-large;">[[Radiation_tissue_injury|BACK]]</span></span>
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Latest revision as of 03:08, 9 July 2019

Pre-emptive treatment with hyperbaric oxygen following radiation therapy for head and neck cancer may prevent the onset of late radiation tissue injury.

Clinical bottom line:
1. Early treatment with HBOT was associated with improved Quality of Life scores for a wide range of symptoms including dry mouth, swallowing difficulties and pain in the mouth
2. Early treatment with prophylactic HBOT may prevent the onset of late radiation tissue injury.

Citation: Teguh DN, Levendag PC, Noever I, Voet P, van der Est H, van Rooij P, Dumans AG, de Boer MF, van der Huls MPC, Sterk W, Schmitz PIM. Early hyperbaric oxygen therapy for reducing radiotherapy side effects: early results of a randomised trial in oropharyngeal and nasopharyngeal cancer. Int J Radiation Oncology 2009; 75(3):711-716.

Corresponding author name and Email: Peter Levendag, [p.levendag@erasmusmc.n

Three-part Clinical Question:For patients who have received radiation therapy for head and neck malignancies, does early treatment with hyperbaric oxygen, versus no specific treatment, prevent late radiation tissue injury?

Search Terms:radiation tissue injury, xerostomia, head and neck cancer

The Study: Non-blinded randomised controlled trial with intention-to-treat.Adult patients diagnosed with oropharyngeal or nasopharyngeal cancer and treated with radiotherapy (46 to 70 Gy).

Control group: (N = 11; analysed): No specific therapy

Experimental group: (N = 8; analysed): 100% oxygen breathing at 2.5 ATA for 90 minutes daily, five days per week to a total of 30 treatments starting within two days after completion of radiotherapy.

​​​​​​​The Evidence:

'Outcome at'12 months

Control group

Mean

HBOT group

Mean

P-value

EORTC H&N35:

Dry mouth

Swallowing

90

40

30

7

0.009

0.011

VAS (Pain in mouth)

7

1

<0.001

  EORTC H&N35: European Organization for Research and Treatment of Cancer Quality of Life assessment tool for head and neck symptoms, 0 = no symptoms, 100 = worst imaginable symptoms;

VAS: Visual Analogue Scale, 0 = no pain, 10 = maximal pain imaginable.

​​​​​​​Comments:

1. Very small trial because of slow recruitment rate, and may be subject to considerable bias. In particular, the baseline QoL scores were generally worse in the control group and may explain the observed differences at follow-up.

2. All outcomes are self-reported in non-blinded subjects.

3. No sham treatment given. Authors state that this is unlike to bias the late treatment effect seen at 18 month follow up.

4. All results given in graphic format and p-values are from regression analysis based on maximum likelihood estimation using Stata 9 software.

Appraised by: Danielle Wood and Michael Bennett, Prince of Wales Hospital; Saturday, 16 April 2016

Email: danspace@gmail.com

Sumhorsa.gif

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