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 |
| Secondary identifying numbers | N0064131831 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 09/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Ms Rebecca J Pitt
Scientific
Scientific
St Chad's Outpatients and Chemotherapy Department
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2003 |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Total of 40 patients required for reflexology and control groups, 20 for each arm of the study. |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
City Hospital
Birmingham
B18 7QH
United Kingdom
B18 7QH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Sandwell and West Birmingham Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
