Structured gastroenterological intervention and improved outcome for patients with chronic gastrointestinal symptoms following pelvic radiotherapy

Henson, Caroline C; Davidson, Susan E; Ang, Yeng; Babbs, Chris; Crampton, J. R.; Kelly, Mark; Lal, Simon; Limdi, Jimmy K.; Whatley, G; Swindell, Ric; Makin, Wendy; McLaughlin, John

doi:10.1007/s00520-013-1782-y

Cited by 21 publications

(16 citation statements)

References 27 publications

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“…In further cohort studies (23,29,30) and a randomized controlled trial (31), we showed that by asking patients to systematically define their symptoms, investigating them for each symptom using an algorithm and then treating all the identified abnormalities, patients improve. Our results have been corroborated by others (32) and suggest that specialist nurses can be trained to manage this patient group using our structured algorithmic approach. This is important since current gastroenterology services are unable to cope with the number of affected patients.…”

Section: Principle 3: the Physiological Model Of Gi Symptomatologysupporting

confidence: 87%

GI Consequences of Cancer Treatment: A Clinical Perspective

Andreyev¹

2016

Radiation Research

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Section: Principle 3: the Physiological Model Of Gi Symptomatologysupporting

confidence: 87%

GI Consequences of Cancer Treatment: A Clinical Perspective

Andreyev¹

2016

Radiation Research

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“…This showed that if a clinician is systematic at eliciting which GI symptoms are present, then systematic in identifying the cause(s) for each symptom and then systematic in following an algorithm of treatment, patients with PRD can be helped significantly. This finding has been confirmed by others [10]. Another vital finding of the ORBIT trial, in an era when there are huge numbers of affected patients, is that a nurse can be trained to manage the patients following the algorithm and, with adequate gastroenterology support, can obtain outcomes similar to those obtained by a senior gastroenterologist in most cases.…”

supporting

confidence: 55%

Pelvic radiation disease

Andreyev

2014

Colorectal Disease

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“…The modified IBDQ was adopted to assess the primary outcome in HOT2, given its successful application in characterising patients with gastrointestinal dysfunction after pelvic radiotherapy. 6 , 8 , 11 , 15 , 16 , 17 None of the exploratory analyses using other instruments to measure rectal bleeding, including LENT SOMA, CTCAE, and EORTC, suggested any clinical benefit of hyperbaric oxygen.…”

Section: Discussionmentioning

confidence: 99%

Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): a randomised, double-blind, sham-controlled phase 3 trial

Glover

Smerdon²,

Andreyev

et al. 2016

The Lancet Oncology

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SummaryBackgroundHyperbaric oxygen has been used as a therapy for patients experiencing chronic intestinal syndromes after pelvic radiotherapy for decades, yet the evidence to support the use of this therapy is based almost exclusively on non-randomised studies. We aimed to provide conclusive results for the clinical benefits of hyperbaric oxygen in patients with chronic bowel dysfunction after radiotherapy for pelvic malignancies.MethodsHOT2 was a double-blind, sham-controlled, phase 3 randomised study of patients (≥18 years) with chronic gastrointestinal symptoms for 12 months or more after radiotherapy and which persisted despite at least 3 months of optimal medical therapy and no evidence of cancer recurrence. Participants were stratified by participating hyperbaric centre and randomly assigned (2:1) by a computer-generated list (block size nine or 12) to receive treatment with hyperbaric oxygen therapy or sham. Participants in the active treatment group breathed 100% oxygen at 2·4 atmospheres of absolute pressure (ATA) and the control group breathed 21% oxygen at 1·3 ATA; both treatment groups received 90-min air pressure exposures once daily for 5 days per week for a total of 8 weeks (total of 40 exposures). Staff at the participating hyperbaric medicine facilities knew the allocated treatment, but patients, clinicians, nurse practitioners, and other health-care professionals associated with patients' care were masked to treatment allocation. Primary endpoints were changes in the bowel component of the modified Inflammatory Bowel Disease Questionnaire (IBDQ) score and the IBDQ rectal bleeding score 12 months after start of treatment relative to baseline. The primary outcome was analysed in a modified intention-to-treat population, excluding patients who did not provide IBDQ scores within a predetermined time-frame. All patients have completed 12 months of follow-up and the final analysis is complete. The trial is registered with the ISRCTN registry, number ISRCTN86894066.FindingsBetween Aug 14, 2009, and Oct 23, 2012, 84 participants were randomly assigned: 55 to hyperbaric oxygen and 29 to sham control. 75 (89%) participants received 40 pressure exposures, all participants returned the IBDQ at baseline, 75 (89%) participants returned the IBDQ at 2 weeks post-treatment, and 79 (94%) participants returned the IBDQ at 12 months post-start of treatment. Patients were excluded from analyses of co-primary endpoints if they had missing IBDQ scores for intestinal function or rectal bleeding at baseline or at 12 months. In an analysis of 46 participants in the active treatment group and 23 participants in the control group, we found no significant differences in the change of IBDQ bowel component score (median change from baseline to 12 months of 4 (IQR −3 to 11) in the treatment group vs 4 (−6 to 9) in the sham group; Mann-Whitney U score 0·67, p=0·50). In an analysis of 29 participants in the active treatment group and 11 participants in the sham group with rectal bleeding at baseline, we also found no significan...

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Structured gastroenterological intervention and improved outcome for patients with chronic gastrointestinal symptoms following pelvic radiotherapy

Cited by 21 publications

References 27 publications

GI Consequences of Cancer Treatment: A Clinical Perspective

GI Consequences of Cancer Treatment: A Clinical Perspective

Pelvic radiation disease

Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): a randomised, double-blind, sham-controlled phase 3 trial

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