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临床试验/NCT03570229
NCT03570229已完成不适用

Pelvic Radiation Injuries After Cancer Treatment: Symptoms, Quality of Life and Experiences Before, Along and After Hyperbaric Oxygenation Treatment

University of Bergen1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2018年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
1
主要终点
Change in Quality of life after HBO-therapy

研究概览

简要总结

Osteoradionecrosis, dermal soft tissue necrosis, radiation cystitis, proctitis and sexual dysfunctions are well-known late-effects after radiation for cancer in the pelvic area, negatively affecting the survivors' quality of life (QOL) and psychosocial wellbeing. Increasing evidence and clinical practice support the use of hyperbaric oxygen treatment (HBOT) as an effective treatment in a variety of radiation injuries, but this is still a field with limited research and knowledge. Especially, there is a knowledge gap on how late radiation tissue injury (LRTI) influences cancer survivors' QOL and psychosocial health in a longitudinal perspective (before, along and after HBOT), as well as the patients' knowledge, expectation and experience from this treatment. This study aims to improve knowledge on these issues.

详细描述

Late effects following radiation of pelvic cancers:

Annually, more than 32000 Norwegians are diagnosed with cancer where approximately 70% will be alive 5 years after diagnosis. About 50% of all cancer patients receive radiation as part of their multimodal cancer treatment, and 50% of these will be long-term survivors. Irradiation therapy is an essential part of the curative treatment of pelvic malignancies, including rectal, uterine and cervical carcinoma. Although precautions and advances are taken, radiation may affect surrounding healthy tissue and lead to acute or chronic radiation injury. About 5-15% of the patients experience late radiation tissue injury (LRTI) that develops months or years after radiation, characterized by poor microcirculation with hypoxia, tissue damage and fibrosis. Consequently, frequent late-effects are related to radiation cystitis, proctitis and enteritis, soft tissue necrosis (skin and vagina) and fistulas with increased frequency, urgency and leakage of urine or faces, diarrhoea and pain. Although these late- effects obviously interfere significantly with the survivors' quality of life (QOL) and psychosocial health, research regarding these consequences is extremely limited.

Hyperbaric oxygen treatment (HBOT) for pelvic LRTI:

HBOT is a treatment modality where the patient is placed in a pressure chamber breathing 100% oxygen while exposed to elevated ambient pressure. HBOT for pelvic LRTI typically involves a treatment pressure of 2.4 ATA Atmospheres Absolute) while breathing oxygen once daily for about 90 minutes for 6 weeks (about 30 'dives' in total). HBOT for LRTI is based upon its ability to increase tissue oxygenation, stimulate neoangiogenesis and cellular regeneration and thereby induce revitalizing and healing of damaged tissue. Although HBOT is a time- consuming treatment, it is well accepted and tolerated by the patients, with few and usually harmless side effects.

Previous studies on the effect of HBOT to reduce pelvic LRTI have not yet yielded broadly accepted and conclusive results. The available studies indicate that HBOT has a positive effect on a variety of conditions, although some studies report no effect. A Cochrane review concludes that HBOT may improve outcomes in various kinds of cancer related radiation injuries (e.g. head and neck, proctitis, osteoradionecrosis), suggesting that other tissues also are likely to respond (e.g. bladder). However, these studies operate with very heterogeneous timepoints for follow-up, varying from right after HBOT is finished to several weeks, months or years after, which may have influenced the outcomes. However, we could not find any publication stating the course of symptomatic improvement for pelvic LRTI. This knowledge-gap is a challenge when informing patients and handling their expectations for this treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • pelvic radiation injury after intended curative radiation therapy for pelvic cancer (prostate, gynecological, and urological and bowel cancers),
  • ≥ 6 months from finished radiation therapy
  • referred to the unit for hyperbaric oxgen treatment (HBOT)
  • aged ≥ 18 years.

排除标准

  • severe physical and/or mental co-morbidity representing a contraindication for HBOT
  • insufficient cognitive or language skills to answer study questionnaires and perform interviews.

结局指标

主要结局

Change in Quality of life after HBO-therapy

时间窗: Change from baseline (T1) to 30 weeks (T7, 6 months after end of HBO-therapy)

Self reported quality of life scale, European Organization for Research and Treatment of Cancer (EORTC QLQ C30) scale, 30 questions, 4-point Likert scale 0-3 for 28 items, 0-6 for two items, total score 0-100 (100=highest level of functioning/ best score)

次要结局

  • Change in Late radiation tissue injury symptoms after HBO-therapy(Change from baseline (T1) to 30 weeks (T7, 6 months after end of HBO-therapy))
  • Time to improvement in Late radiation tissue injury symptoms(Time from baseline (T1) to significant improvement (at least 0,5 SD) up to 30 weeks (T7) after end of HBO-therapy)
  • Long-term change in Quality of life(Change from baseline (T1) to 58 weeks (T8, 1 year after end of HBO-therapy))
  • Satisfaction With Care(T3 (after 6 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

May Aasebø Hauken

Prinsipal Investigator

University of Bergen

研究点 (1)

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