Contact information
Type
Scientific
Primary contact
Dr Clare Shaw
ORCID ID
Contact details
Nutrition and Dietetic Department
The Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom
+44 020 7352 8171 ext 1653
clare.shaw@rmh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258184657
Study information
Scientific title
Acronym
Study hypothesis
Hot 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
Not provided at time of registration
Study design
Randomized single blinded crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Hot flushes
Intervention
Randomized single blinded crossover study of two sprays
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The number of women choosing a hydrolat spray in preference to a water spray to palliate hot flushes.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/08/2006
Overall trial end date
15/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Any woman suffering from hot flushes as a result of treatment for breast cancer.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
44
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
16/08/2006
Recruitment end date
15/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nutrition and Dietetic Department
London
SW3 6JJ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Marsden NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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/18940714
Publication citations
-
Results
Dyer J, Ashley S, Shaw C, A study to look at the effects of a hydrolat spray on hot flushes in women being treated for breast cancer., Complement Ther Clin Pract, 2008, 14, 4, 273-279, doi: 10.1016/j.ctcp.2008.02.003.