A study of lidocaine jelly for pain relief in women receiving gonadotropin-releasing hormone analog injection during breast cancer treatment
| ISRCTN | ISRCTN99910605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99910605 |
- Submission date
- 05/12/2022
- Registration date
- 09/12/2022
- Last edited
- 03/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The purpose of this study was to evaluate the pain and anxiety scores of women receiving gonadotropin-releasing hormone analog (GnRHa) injections during breast cancer treatment and to determine whether an application of a topical anesthetic agent before the GnRHa injection is effective in reducing pain and anxiety.
Who can participate?
Premenopausal women with hormone receptor-positive breast cancer after surgery who received GnRHa injection
What does the study involve?
Participants will have topical lidocaine jelly applied before GnRHa injection.
What are the possible benefits and risks of participating?
The possible benefits of participating include the improvement of pain and anxiety and there are no anticipated risks.
Where is the study run from?
Changhua Christian Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
February 2019 to July 2023
Who is funding the study?
Changhua Christian Hospital (Taiwan)
Who is the main contact?
Hung-Wen Lai, MD, PhD, 143809@cch.org.tw
Contact information
Principal Investigator
Comprehensive Breast Cancer Center
Changhua Christian Hospital
135 Nanxiao Street
Changhua County
500
Taiwan
 ORCID ID |
0000-0001-9541-2013 |
|---|---|
| Phone | +886 4 723 8595 |
| 143809@cch.org.tw |
Principal Investigator
Changhua Christian Hospital
135 Nanxiao Street
Changhua
500
Taiwan
| Phone | +886 4 723 8595 |
|---|---|
| hwlai650420@gmail.com |
Study information
| Study design | Prospective non-randomized open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparison of pain and anxiety in premenopausal women with hormone receptor-positive breast cancer receiving gonadotropin-releasing hormone analog injection before and after application of topical lidocaine jelly |
| Study objectives | Application of topical lidocaine jelly before the injection of gonadotropin-releasing hormone analog (GnRHa) would reduce pain or anxiety in premenopausal women with hormone receptor-positive breast cancer |
| Ethics approval(s) | Approved 22/07/2019, Institutional Review Board of Changhua Christian Hospital (No. 176, Zhonghua Rd, Changhua City, Changhua County, 500, Taiwan; +886 47238595; d9065@cch.org.tw), ref: CCH IRB No.:190708 |
| Health condition(s) or problem(s) studied | Premenopausal women with hormone receptor-positive breast cancer |
| Intervention | Questionnaires were used in the evaluation of pain and anxiety experienced during four cycles (1-4th) of GnRHa (goserelin or leuprorelin) injections and recorded as the baseline. Pain and anxiety scores were graded using the visual analog scale (VAS), ranging from 0 (no or minimal pain or anxiety) to 10 (maximal pain or anxiety experienced). During the next four cycles (5-8th) of GnRHa injections, patients were provided with lidocaine jelly and instructed to use a single application (5 g) of topical gel 5-10 mins before the injection of GnRHa. And the pain and anxiety scores were recorded after GnRHa injection. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Lidocaine jelly |
| Primary outcome measure | Pain and anxiety measured using a visual analog scale (VAS) at baseline and the 1st to 8th cycles of GnRHa injections |
| Secondary outcome measures | Levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol measured using a blood test before and after the GnRHa injection |
| Overall study start date | 01/02/2019 |
| Completion date | 21/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Key inclusion criteria | Premenopausal women with hormone receptor-positive breast cancer who had undergone breast cancer operations and were indicated for GnRHa injection |
| Key exclusion criteria | 1. Unwilling to receive application of topical lidocaine jelly 2. Refuse questionnaire survey of pain and anxiety score |
| Date of first enrolment | 01/08/2019 |
| Date of final enrolment | 30/01/2023 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Changhua County
500
Taiwan
Sponsor information
Hospital/treatment centre
135 Nanxiao Street
Changhua County
500
Taiwan
| Phone | +886 4 7238595 |
|---|---|
| D3925c@cch.org.tw | |
| Website | https://www2.cch.org.tw/cch_english/About_CCH.aspx?Page=1 |
"ROR" |
https://ror.org/05d9dtr71 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CCH
- Location
- Taiwan
Results and Publications
| Intention to publish date | 30/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
03/02/2023: Internal review.
08/12/2022: Trial's existence confirmed by the Institutional Review Board of Changhua Christian Hospital.
