Stellate ganglion block reduces hot flushes and night awakenings in breast cancer survivors: a pilot study
| ISRCTN | ISRCTN14318565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14318565 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/04/2008
- Registration date
- 08/05/2008
- Last edited
- 03/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Eugene Lipov
Scientific
Scientific
2260 W. Higgins Rd.
Ste. 101
Hoffman Estates
60195
United States of America
Study information
| Study design | Interventional, single-centre, single arm, non-placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The hypothesis is that stellate ganglion block decreases hot flushes and night awakenings in breast cancer survivors. The current project is to prove that hypothesis. |
| Ethics approval(s) | Ethics approval received from the Alexian Brothers Hospital Network Institutional Review Board on the 5th October 2006. |
| Health condition(s) or problem(s) studied | Hot flushes, night awakenings |
| Intervention | The intervention used was a stellate ganglion block at C6. Each patient had 1 - 2 blocks depending on the patient. Follow up was from before treatment to 12 weeks post-initial treatment. Observed occurrences were documented before and after intervention. |
| Intervention type | Other |
| Primary outcome measure | 1. Hot flush qualitative scores - mild to very severe 2. Quantitative hot flush occurrences per day 3. Night awakening per night Data was collected before the intervention and daily after the intervention for 12 weeks. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2007 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 13 |
| Key inclusion criteria | 1. 30 - 70 year old female breast cancer survivors 2. American Society of Anaesthesiologists (ASA) scores 3 or below |
| Key exclusion criteria | Does not comply with the above inclusion criteria. |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- United States of America
Study participating centre
2260 W. Higgins Rd.
Hoffman Estates
60195
United States of America
60195
United States of America
Sponsor information
Advanced Pain Centers (USA)
Hospital/treatment centre
Hospital/treatment centre
2260 W. Higgins Rd.
Ste 101
Hoffman Estates
60195
United States of America
| Website | http://www.painmngt.com/ |
|---|
Funders
Funder type
Other
Investigator initiated and funded (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/06/2008 | Yes | No |
