Condition category
Signs and Symptoms
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/10/2011
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 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

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

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

  1. 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.

Additional files

Editorial Notes