Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0064131831
Study information
Scientific title
A pilot study for a randomised controlled trial to determine if reflexology can help improve neurological damage caused by taxane chemotherapy drugs
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Neurotoxicity after chemotherapy
Intervention
Single centre, patient volunteers, prospective, controlled, therapeutic, observational, randomised, questionnaire study.
Reflexology vs no reflexology
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2003
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Total of 40 patients required for reflexology and control groups, 20 for each arm of the study.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2003
Recruitment end date
01/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
City Hospital
Birmingham
B18 7QH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sandwell and West Birmingham Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary