Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/05/2012
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

Dr J Stringer

ORCID ID

Contact details

Adult Leukaemia Unit
Christie Hospial NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0063054436

Study information

Scientific title

Acronym

Study hypothesis

1. To evaluate the aromatherapy/massage service offered to patients on the Adult Leukaemia Unit (ALU) of the Christie Hospital NHS Trust
2. To assess whether massage with essential oils is more effective than massage with base oil or time for peace and calm at reducing physiological and psychological symptoms of stress and perception of pain

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

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer: Leukaemia

Intervention

1. Arm A: No massage
2. Arm B: Massage with essential oil
3. Arm C: Massage without essential oil

Those randomised to either of the two experimental arms will receive a part body massage once a week for the duration of their stay as an in-patient on the ALU (with or without essential oils depending on which arm they are in).
Those in the control arm will rest on their beds for an equivalent length of time.

All study participants will rest on their beds for twenty minutes prior to treatment after which blood samples will be taken for hormone levels. Once this has been done patients will be asked to fill in the quality of life questionnaire. Following completion, those patients in the experimental groups will receive their massage. Following the therapy session the patients will be allowed to rest for 10 minutes then more blood samples will be taken for hormone levels. This sampling will be repeated half hourly for two hours. At this final session a semi-structured interview will be conducted to aid evaluation of the effect the therapist may have on the patient. The patient will also be asked to fill in pain and quality of life measures at this point. The questionnaires and blood sampling will be repeated after 24 hours.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Reducing cortisol and prolactin levels

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2001

Overall trial end date

15/08/2003

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

189 NHS patients maximum

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2001

Recruitment end date

15/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Adult Leukaemia Unit
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Christie Hospital 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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18300336

Publication citations

  1. Results

    Stringer J, Swindell R, Dennis M, Massage in patients undergoing intensive chemotherapy reduces serum cortisol and prolactin., Psychooncology, 2008, 17, 10, 1024-1031, doi: 10.1002/pon.1331.

Additional files

Editorial Notes