None listed
Conditions
Brief summary
The purpose of the proposed study is to evaluate effectiveness and cost effectiveness of heat therapy and/or massage in addition to standard care in people with chemotherapy induced peripheral neuropathy. Who is it for? You may be eligible to join this study if you aged 18 years or over and meet study definition of chemotherapy induced peripheral neuropathy. Study details Patients will be assigned on a 'chance' basis, (like flipping a coin) to receive standard care or an intervention of standard care and heat therapy treatment for four weeks. If after four weeks the intervention decreases CIN nervous system symptoms then the intervention will continue for another 4 weeks. If symptoms do not improve, then the patient will be assigned on a chance basis to receive an alternative intervention of standard care and heat therapy, standard care and massage or standard care, heat therapy and massage. The second intervention will then be received for four weeks. Chemotherapy induced peripheral neuropathy has become a significant health issue which can cause treatment delays and affect functional abilities and quality of life. There are currently no pharmacological interventions that effectively prevent or manage CIN.
Interventions
Treatment Group A - Heat Treatment - usual treatment to manage symptoms and heat treatment. The participant will continue to have the same treatment they would have had if they were not in the trial and will be asked to put their hands and or feet on a heat pad for 20 minutes a day (tailored according to patient tolerance to a minimum duration of 10 minutes), 4 times a week, for 4 weeks. A heat pad will be provided to the participant. A study nurse will provide education regarding heat pad use t
Treatment Group A - Heat Treatment - usual treatment to manage symptoms and heat treatment. The participant will continue to have the same treatment they would have had if they were not in the trial and will be asked to put their hands and or feet on a heat pad for 20 minutes a day (tailored according to patient tolerance to a minimum duration of 10 minutes), 4 times a week, for 4 weeks. A heat pad will be provided to the participant. A study nurse will provide education regarding heat pad use to the participant via phone or web based teleconferencing. Treatment Group B - Massage Treatment - usual treatment to manage symptoms and massage treatment. The participant will continue to have the same treatment they would have had if they were not in the trial and will be asked to massage their hands and or feet using a massage ball for 5 minutes a day, 4 times a week, for 4 weeks. The participant will be provided with a small massage ball (approximately 10cm diameter) with raised finger-like protrusions to aid the massage. A study nurse will provide education regarding massage ball use to the participant via phone or web based teleconferencing. Treatment Group C - Heat and Massage Treatment - usual treatment to manage symptoms, heat and massage treatment. This treatment is for 4 weeks and includes usual treatment plus both heat and massage treatment. A study nurse will provide education regarding heat pad and massage ball use to the participant via phone or web based teleconferencing. Participants will be allocated to usual care or Treatment A for the first 4 weeks of the study. At the end of week 4, participants will be asked to complete surveys and the response to treatment will be calculated. If the participant in the usual treatment group has not had a response to usual treatment at the end of 4 weeks, they will be re-allocated to either Treatment A or B for weeks 5 to 8. If the participant in the Treatment A group has not had a response to treatment at the end of 4 weeks, they will be re-allocated to Treatment B or C for weeks 5 to 8. If the participant has had a response to usual treatment or Treatment A in the first 4 weeks they will remain on the same treatment for weeks 5 to 8. Fidelity of the intervention will be assessed using the framework for behavioural interventions recommended by National Institutes of Health (NIH, US). Intervention Fidelity Strategies Study Design procedures have been designed to ensure that the study can adequately test its hypotheses in relation to the underlying theory and clinical practices. Training Providers: standardized provider training includes procedures to ensure that interventionists have been satisfactorily trained to deliver the intervention to study participants. This will involve: o Provision of a study manual to all staff which includes: o Generic study related information: standard operating procedures, study overview, reporting/documentation guidelines, communication flowchart, rationale for the study treatment, treatment side effects o Intervener specific information: Job description, intervention protocol, related literature, quality assurance and monitoring o Training program including didactic presentations, performance assessment and role play o Manualised intervention protocol Delivery of Treatment: Treatment procedures will be monitored to improve delivery of intervention and comparison of conditions, and ensure that treatment is delivered as intended, through: o Bi monthly teleconferences o Quality assurance monitoring – first five sessions observed by trial manager (trainer), and self and trainer assessment completed using a checklist; if performance is satisfactory at this point one session per month will be recorded and self and trainer assessment completed with feedback provided on performance. o Omissions and/or protocol deviations with interveners reviewed on an individual basis. o Intervention checklist completed at the end of each intervention to allow protocol deviation tracking across interveners and conditions. o Minimising contamination between conditions by training interveners to address participant questions about randomisation and their assigned condition using non-biased explanations Receipt of Treatment: Treatment receipt focuses on the participant and includes procedures to assure that the treatment was both received and understood. This will be achieved by: o Ensuring participants understand the information provided in intervention, by checking through use of active questions and behavioural observations Enactment of Treatment Skills: Enactment of treatment skills includes processes to monitor and improve participant ability to perform treatment-related behavioural skills and cognitive strategies in relevant real-life settings as intended. This will be achieved by: o ensuring participants are able to demonstrate use of treatments through observing at least one practice session and recording observations in Intervention checklist at the end of each session o checking in with participants a minimum of once, up to 3 times in the first week of commencing the first intervention, then weekly until the end of the trial period Intervention Adherence - participants will be asked to complete diaries to record intervention sessions and standard care treatments.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed