Condition category
Urological and Genital Diseases
Date applied
19/04/2008
Date assigned
08/05/2008
Last edited
03/06/2008
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 Eugene Lipov

ORCID ID

Contact details

2260 W. Higgins Rd.
Ste. 101
Hoffman Estates
60195
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the Alexian Brothers Hospital Network Institutional Review Board on the 5th October 2006.

Study design

Interventional, single-centre, single arm, non-placebo controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2007

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. 30 - 70 year old female breast cancer survivors
2. American Society of Anaesthesiologists (ASA) scores 3 or below

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

13

Participant exclusion criteria

Does not comply with the above inclusion criteria.

Recruitment start date

01/01/2007

Recruitment end date

01/01/2008

Locations

Countries of recruitment

United States of America

Trial participating centre

2260 W. Higgins Rd.
Hoffman Estates
60195
United States of America

Sponsor information

Organisation

Advanced Pain Centers (USA)

Sponsor details

2260 W. Higgins Rd.
Ste 101
Hoffman Estates
60195
United States of America

Sponsor type

Hospital/treatment centre

Website

http://www.painmngt.com/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (USA)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18485819

Publication citations

  1. Results

    Lipov EG, Joshi JR, Sanders S, Wilcox K, Lipov S, Xie H, Maganini R, Slavin K, Effects of stellate-ganglion block on hot flushes and night awakenings in survivors of breast cancer: a pilot study., Lancet Oncol., 2008, 9, 6, 523-532, doi: 10.1016/S1470-2045(08)70131-1.

Additional files

Editorial Notes