A study to look at the effects of a hydrolat spray to palliate hot flushes in women being treated for breast cancer

ISRCTN ISRCTN98658526
DOI https://doi.org/10.1186/ISRCTN98658526
Secondary identifying numbers N0258184657
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
18/10/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Clare Shaw
Scientific

Nutrition and Dietetic Department
The Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Phone +44 020 7352 8171 ext 1653
Email clare.shaw@rmh.nhs.uk

Study information

Study designRandomized single blinded crossover study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesHot flushes are a common side effect of treatment for breast cancer. Research has shown that having more problematic hot flushes and night sweats was associated with more anxiety and sleep problems, poorer emotional and social functioning and worse body image. Current advice suggests cool sprays and moist wipes to lower skin temperature. Although anecdotal evidence for the beneficial effects of hydrolats is quoted in text books and aromatherapy teaching programmes, no research into specific effects for hot flushes has been found. The principle research question is to establish whether a peppermint and neroli hydrolat spray is preferred by woman over a distilled water spray to help palliate the unpleasant effects of hot flushes.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Hot flushes
InterventionRandomized single blinded crossover study of two sprays
Intervention typeOther
Primary outcome measureThe number of women choosing a hydrolat spray in preference to a water spray to palliate hot flushes.
Secondary outcome measuresNot provided at time of registration
Overall study start date16/08/2006
Completion date15/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants44
Key inclusion criteriaAny woman suffering from hot flushes as a result of treatment for breast cancer.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment16/08/2006
Date of final enrolment15/01/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Nutrition and Dietetic Department
London
SW3 6JJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Royal Marsden NHS Foundation Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2008 Yes No