Investigation of an Abdominal Compression Device
-
- STATUS
- Recruiting
-
- participants needed
- 30
-
- sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
Summary
This study is applicable to patients undergoing lower lung or abdomen stereotactic ablative body radiotherapy (SABR) treatment. The purpose of the ACE 01 study is to identify if, the volume of healthy tissue within the treatment area and therefore subsequent side effects, can be reduced by using a commercially available abdominal compression device to minimise breathing related movement. The secondary aim will be to assess patient compliance and comfort of thedevice. This will be assessed by asking the patient to complete a 'patient comfort questionnaire'. In addition the radiographers will be asked to complete a 'satisfaction questionnaire' to determine ease and reproducibility of use.
Description
Stereotactic ablative body radiotherapy (SABR) offers the ability to deliver a high dose of radiotherapy accurately to small tumours. It is an established, effective, non-invasive treatment option for early lung cancers as an alternative to surgery and in the treatment of limited spread of cancer (called oligo-metastatic disease) in the context of clinical trials (CORE, SARON, ABC-07 etc.). In order to deliver a high dose of radiation without damaging the surrounding structures, an accurate map of the tumour and the surrounding organs and their relationship to each other when moving (for e.g. during breathing) is important. This is usually achieved by getting a radiotherapy treatment planning 4 dimensional CT scan (4D-CT). When either the tumour or organ around them (like the lung) are moving excessively it becomes difficult to target the radiation beams and often the only solution is to treat a larger volume which covers the extent of the movement. Treating larger volumes often leads to more toxicity to the surrounding tissues.Therefore managing motion is critical to increasing tumour control probability (TCP) and reducing normal tissue complication probability (NTCP). In this context, the question of reducing the movement caused by breathing, of tumours in the lower lung and upper abdomen (like the liver, adrenals, kidney etc) is an area of intense interest. Various technical and physical methods exist to help improve motion management in patients under going radiotherapy. By limiting the movement, the target volume is smaller and this enables treatment of the tumour to high doses with lesser toxicity as some of the toxicity of radiotherapy is proportionate to the volume treated i.e. lower the volume of treatment lesser the risk of toxicity.
Abdominal compression is one such method and is well accepted to be beneficial in reducing tumour motion.
However, many of the previous studies require expensive and resource intensive immobilisation devices, costing, in many cases in excess of 10,000. This study will investigate the use of an independent compression device which can be used with any existing immobilisation system and costs in the region of 1,500. If proven to be beneficial this will allow many smaller centres or centres with budget limitations to also achieve the benefits of abdominal compression without extensive resource and cost requirements.
Details
Condition | Lung Neoplasm, Gastropathy, Gastric Cancer, Gastric Cancer |
---|---|
Age | 18years - 100years |
Treatment | Abdominal compression belt system |
Clinical Study Identifier | NCT04270890 |
Sponsor | The Clatterbridge Cancer Centre NHS Foundation Trust |
Last Modified on | 16 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.