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 |
| Protocol serial number | N0258184657 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding |
- 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
Scientific
Nutrition and Dietetic Department
The Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom
| Phone | +44 020 7352 8171 ext 1653 |
|---|---|
| clare.shaw@rmh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized single blinded crossover study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Hot flushes |
| Intervention | Randomized single blinded crossover study of two sprays |
| Intervention type | Other |
| Primary outcome measure(s) |
The number of women choosing a hydrolat spray in preference to a water spray to palliate hot flushes. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 44 |
| Key inclusion criteria | Any woman suffering from hot flushes as a result of treatment for breast cancer. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 16/08/2006 |
| Date of final enrolment | 15/01/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Nutrition and Dietetic Department
London
SW3 6JJ
United Kingdom
SW3 6JJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
