Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rebecca J Pitt

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes