None listed
Conditions
Brief summary
Brief description of the study purpose This study aims to investigate whether self-guided use of sensory massage balls is a feasible, safe and effective way to reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN), such as numbness, tingling, pain and weakness, and to improve quality of life for people affected by CIPN. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older who are receiving chemotherapy or have completed chemotherapy within the previous month, are receiving care through Tweed Valley Hospital, and have symptoms consistent with chemotherapy-induced peripheral neuropathy. Study details Eligible participants will be randomly assigned to one of two groups. One group will receive a set of sensory massage balls and instructions for daily self-guided use at home for 8 weeks, while the other group will receive usual care in the form of publicly available physical activity guidance. After completing Week 8 assessments, participants in the usual care group will also receive the massage ball set if no intervention-related safety concerns are identified. Participants will attend study assessments at baseline, Week 8 and Week 16. During the intervention period, participants using the massage balls will record their usage and symptoms in a daily logbook and receive an initial face-to-face training session. Study assessments will evaluate neuropathy severity, quality of life, balance, strength and hand dexterity. It is hoped that the results of this pilot study will inform larger future clinical trials and contribute to the development of supportive care strategies for people experiencing chemotherapy-induced peripheral neuropathy.
Interventions
Arm 1: Sensory Massage Ball Intervention
Participants will receive a set of sensory ("spikey") massage balls of varying firmness and texture, together with written instructions and video guidance (in development). Following baseline assessment and randomisation, participants will undertake self-directed use of the massage balls at home for 8 weeks. Participants will record usage frequency, duration and symptoms in a daily log. A 1 hour familiarisation session will be provided by trained study pe
Arm 1: Sensory Massage Ball Intervention Participants will receive a set of sensory ("spikey") massage balls of varying firmness and texture, together with written instructions and video guidance (in development). Following baseline assessment and randomisation, participants will undertake self-directed use of the massage balls at home for 8 weeks. Participants will record usage frequency, duration and symptoms in a daily log. A 1 hour familiarisation session will be provided by trained study personnel. Logs will be reviewed at Week 8 and Week 16. Participants will be instructed to contact the research team if adverse events or worsening symptoms occur. Materials Sensory massage balls Participant information sheets Instructional videos Daily logbook Mode of delivery Initial face-to-face instruction Individual home-based practice Duration Daily self-guided use over 8 weeks Adherence Daily participant logs reviewed at Week 8 and Week 16.
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older Currently receiving chemotherapy, or completed chemotherapy within the previous month Receiving care through Tweed Valley Hospital Current symptoms consistent with CIPN Clinically diagnosed (Grade 1 CTCAE) or self-identified CIPN Medically cleared for participation Adequate English language proficiency Able to provide informed consent
Exclusion criteria
Unable to provide informed consent No current CIPN symptoms Chemotherapy completed more than one month prior to baseline testing Previous chemotherapy treatment for prior cancer diagnosis Other neuropathies (e.g., diabetic neuropathy) Conditions affecting peripheral nerve function (e.g., lymphoedema, peripheral artery disease) Unwilling to undergo randomisation
Outcome results
None listed