A pilot study for a randomised controlled trial to determine if reflexology can help improve neurological damage caused by taxane chemotherapy drugs

ISRCTN	ISRCTN95527771
DOI	https://doi.org/10.1186/ISRCTN95527771
Protocol serial number	N0064131831
Sponsor	Department of Health
Funder	Sandwell and West Birmingham Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Ms Rebecca J Pitt
Scientific

St Chad's Outpatients and Chemotherapy Department
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot study for a randomised controlled trial to determine if reflexology can help improve neurological damage caused by taxane chemotherapy drugs
Study objectives	Does reflexology help to improve the neurotoxicity (tingling and numbness) in the hands and feet experienced by some patients following cytotoxic chemotherapy with Paclitaxel and Docetaxel? Can the benefits of using reflexology in this setting be proven by the use of nerve conduction studies? (i.e. will there be a statistical difference over time in the reflexology group compared to the control group?). Does the use of reflexology in this context help patients to feel better in themselves? (Quality of Life questionnaire will be used for this).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neurotoxicity after chemotherapy
Intervention	Single centre, patient volunteers, prospective, controlled, therapeutic, observational, randomised, questionnaire study. Reflexology vs no reflexology
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/06/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2003
Date of final enrolment	01/06/2004

City Hospital

Birmingham
B18 7QH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes