A sequential multiple assignment randomised trial (SMART) of nursing interventions including standard treatment, heat treatment, self-massage treatment and heat and self-massage treatment combined to reduce pain associated with chemotherapy induced peripheral neuropathy (CIPN Study)

Queensland University of Technology0 个研究点目标入组 649 人开始时间: 2017年8月18日最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•Greater than or equal to 18 years of age
•Able to read, write, and understand English
•Internet access is not essential but participant must be willing and able to see a health care professional and or send photo/s via email or phone in relation to any adverse events
•Capacity to give informed consent
•Have an Australian-modified KPS score of greater than or equal to 60
•Are within greater than or equal to 3 months to less than or equal to 5 years of completing a course of CTX known to cause peripheral neuropathy such as those containing taxane or platinum-based agents for the treatment of cancer
•Meet study definition of CIPN:
•a) Changes in sensation and/or pain in their feet and/or hands of greater than or equal to 3 month duration following the completion of CTX; and
•b) A current rating of greater than or equal to 3 on a 0 to 10 numerical rating scale (NRS) on any one of the following sensations from the PQAS (i.e., numb, tender, shooting, sensitive, electrical, tingling radiating, throbbing, cramping, itchy, unpleasant)
•Able to comply with all study requirements

•The presence of any of the following criteria will constitute cause for the exclusion of the participant:
•Any prior history of conditions associated with neuropathy, including diabetes mellitus (treated with insulin); peripheral vascular disease; history of chronic vitamin B12 deficiency; unstable/severe thyroid dysfunction (confirmed by treating medical practitioner); HIV neuropathy; current cervical or lumbar pain with radiculopathy, or another painful condition that is difficult for them to distinguish from CIPN; or a history of hereditary sensory or autonomic neuropathy; and/or a hereditary mitochondrial disorder. These exclusion criteria will minimise a number of confounding factors that could influence analysis of the study data.
•Any condition or treatment for which heat or massage therapy may be contraindicated, including increased risk of haemorrhage, impaired cognitive ability, impaired skin integrity, known malignant hypertension, pacemaker and pregnancy.

发起方