Clinical trial NCT04165512: Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema
Official title: Ultrasonographic Evaluation of the Effectiveness of Stellate Ganglion Block in Patients With Breast Cancer Related Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema of Upper Limb
Breast Cancer Related Lymphedema
Keywords: lymphedema
breast cancer
stellate ganglion
treatment
ultrasound
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lymphedema is a condition characterized by generalized or regional accumulation of protein-rich interstitial fluid as a result of impaired lymphatic circulation due to congenital or acquired disorders. Lymphedema is diagnosed through evaluations of its clinical criteria. Lymphedema is mostly evaluated through arm circumference measurements, water displacement measurements, tonometry, bioimpedance analysis, ultrasonography (US), computed tomography, lymphoscintigraphy and magnetic resonance imaging (MRI). Targets in the treatment of lymphedema include controlling the symptoms and preventing complications. A multimodal technique called complete decongestive therapy (CDT) is considered the gold standard of the treatment of lymphedema. In the literature, there are also studies showing that stellate ganglion block in breast cancer-related lymphedema treatment improves lymphedema and symptoms. Cervical stellate ganglion block is an invasive method used for the diagnosis and treatment of sympathetic pain and symptoms of upper extremity. Although it can be performed with fluoroscopy, CT and MRI, there has been increasing interest in ultrasound-guided technique since it has been fast, easy and cost-effective for the last few years. However, there are limited studies to provide sufficient evidence for the use of stellate ganglion block as an alternative treatment for lymphedema and detailed studies are needed in this area. The aim of this study is ultrasonographic evaluation of the efficacy of stellate ganglion block in the treatment of patients with breast cancer related lymphedema that is resistant to conservative treatment methods .

Detailed description: Lymphedema is a condition characterized by generalized or regional accumulation of protein-rich interstitial fluid as a result of impaired lymphatic circulation due to congenital or acquired disorders. Lymphedema is diagnosed through evaluations of its clinical criteria. In addition to swelling of the affected extremities, certain symptoms, such as pain, fatigue, tightness, heaviness, tingling, weakness, and movement restriction, can also be seen in cases of lymphedema. Arm circumference measurements and volumetric methods are the most commonly used methods for calculating limb volume. In addition, soft tissue edema can be quantitatively measured by ultrasonography (US), computed tomography, lymphoscintigraphy and magnetic resonance imaging (MRI). Among these, US has been used more frequently in the evaluation of lymphedema. Ultrasonographic evaluation of the skin and subcutaneous tissue helps to determine the severity of lymphedema and the effectiveness of treatment. The reliability and utility of ultrasound in subcutaneous echogenicity grade (SEG) and subcutaneous echo-free space (SEFS) grade have been demonstrated in patients with breast cancer-related lymphedema. Targets in the treatment of lymphedema include controlling the symptoms and preventing complications. A multimodal technique called complete decongestive therapy (CDT) is considered the gold standard of the treatment of lymphedema. In the literature, there are also studies showing that stellate ganglion block in breast cancer-related lymphedema treatment improves lymphedema and symptoms. Cervical stellate ganglion block is an invasive method used for the diagnosis and treatment of sympathetic pain and symptoms of upper extremity. Although it can be performed with fluoroscopy, CT and MRI, there has been increasing interest in ultrasound-guided technique since it has been fast, easy and cost-effective for the last few years. However, there are limited studies to provide sufficient evidence for the use of stellate ganglion block as an alternative treatment for lymphedema and detailed studies are needed in this area. The aim of this study is ultrasonographic evaluation of the efficacy of stellate ganglion block in the treatment of patients with breast cancer related lymphedema that is resistant to conservative treatment methods.

Patients with breast cancer-related lymphedema will be evaluated for the study. For the diagnosis of lymphedema, detailed physical examination and limb circumference measurements will be performed. The patients with stage 2-3 lymphedema according to ISL staging, who had passed at least 3 months after breast surgery and did not response to conservative treatment methods will be included to the study. After obtaining written and oral informed consent of patients, US- guided stellate ganglion block will be applied two times at two-week intervals. Patients will be evaluated before injections (weeks 0 and 2) and 2 weeks after the last injection (week 4) and at 3 months of treatment. Arm circumference will be measured from 5 different areas, shoulder range of motion (ROM) will be evaluated with a goniometer, pain, and tightness and heaviness sensation will be assessed with visual analog scale. Quick-DASH questionnaire and Lymphedema Life Impcat scale will be applied to the patients. SEG and SEFS grade will be performed by evaluating subcutaneous tissue with USG.

After data collection, analysis will be performed with the appropriate statistical method.

Eligibility criteria: Inclusion Criteria:

* circumference difference of 2 cm or more between the affected and unaffected arm
* stage 2-3 lymphedema according to ISL staging
* aged between 18-70 years
* at least 3 months of follow-up breast surgery
* no response to the complete decongestive therapy enough

Exclusion Criteria:

* signs of cellulitis, lymphangitis, fungal infection,
* metastases to the lymph nodes
* uncontrolled psychiatric and systemic diseases
* contraindications for stellate ganglion block

Primary outcomes:
measure: Arm circumference difference
timeFrame: before treatment (T0)
measure: Arm circumference difference
timeFrame: 2nd week of treatment (T1)
measure: Arm circumference difference
timeFrame: 4th week of treatment (T2)
measure: Arm circumference difference
timeFrame: 3rd month of treatment (T3)
measure: Subcutaneous echogenicity grade (SEG)
timeFrame: before treatment (T0)
measure: Subcutaneous echogenicity grade (SEG)
timeFrame: 2nd week of treatment (T1)
measure: Subcutaneous echogenicity grade (SEG)
timeFrame: 4th week of treatment (T2)
measure: Subcutaneous echogenicity grade (SEG)
timeFrame: 3rd month of treatment (T3)
measure: Subcutaneous echo-free space (SEFS) grade
timeFrame: before treatment (T0)
measure: Subcutaneous echo-free space (SEFS) grade
timeFrame: 2nd week of treatment (T1)
measure: Subcutaneous echo-free space (SEFS) grade
timeFrame: 4th week of treatment (T2)
measure: Subcutaneous echo-free space (SEFS) grade
timeFrame: 3rd month of treatment (T3)
measure: shoulder range of motion (ROM) will be evaluated with a goniometer
timeFrame: before treatment (T0)
measure: shoulder range of motion (ROM) will be evaluated with a goniometer
timeFrame: 2nd week of treatment (T1)
measure: shoulder range of motion (ROM) will be evaluated with a goniometer
timeFrame: 4th week of treatment (T2)
measure: shoulder range of motion (ROM) will be evaluated with a goniometer
timeFrame: 3rd month of treatment (T3)
measure: Pain, tightness and heaviness sensation
timeFrame: before treatment (T0)
measure: Pain, tightness and heaviness sensation
timeFrame: 2nd week of treatment (T1)
measure: Pain, tightness and heaviness sensation
timeFrame: 4th week of treatment (T2)
measure: Pain, tightness and heaviness sensation
timeFrame: 3rd month of treatment (T3)
Secondary outcomes:
measure: Activity and participation - Quick-DASH
timeFrame: before treatment (T0)
measure: Activity and participation - Quick-DASH
timeFrame: 2nd week of treatment (T1)
measure: Activity and participation - Quick-DASH
timeFrame: 4th week of treatment (T2)
measure: Activity and participation - Quick-DASH
timeFrame: 3rd month of treatment (T3)
measure: Quality of life - Lymphedema Life Impact Scale
timeFrame: before treatment (T0)
measure: Quality of life - Lymphedema Life Impact Scale
timeFrame: 2nd week of treatment (T1)
measure: Quality of life - Lymphedema Life Impact Scale
timeFrame: 4th week of treatment (T2)
measure: Quality of life - Lymphedema Life Impact Scale
timeFrame: 3rd month of treatment (T3)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Canan Şanal-Toprak
Study officials:
affiliation: Marmara University
name: Gülseren Akyüz, Prof
role: STUDY_CHAIR
affiliation: Marmara University
name: Canan Şanal-Toprak, Asst. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suehiro K, Morikage N, Yamashita O, Harada T, Samura M, Takeuchi Y, Mizoguchi T, Nakamura K, Hamano K. Skin and Subcutaneous Tissue Ultrasonography Features in Breast Cancer-Related Lymphedema. Ann Vasc Dis. 2016;9(4):312-316. doi: 10.3400/avd.oa.16-00086. Epub 2016 Nov 25.
citation: Kim J, Park HS, Cho SY, Baik HJ, Kim JH. The effect of stellate ganglion block on intractable lymphedema after breast cancer surgery. Korean J Pain. 2015 Jan;28(1):61-3. doi: 10.3344/kjp.2015.28.1.61. Epub 2015 Jan 2.
citation: Kim JG, Bae SO, Seo KS. A comparison of the effectiveness of complex decongestive physiotherapy and stellate ganglion block with triamcinolone administration in breast cancer-related lymphedema patients. Support Care Cancer. 2015 Aug;23(8):2305-10. doi: 10.1007/s00520-014-2593-5. Epub 2015 Jan 11.
citation: Park JH, Min YS, Chun SM, Seo KS. Effects of stellate ganglion block on breast cancer-related lymphedema: comparison of various injectates. Pain Physician. 2015 Jan-Feb;18(1):93-9.
citation: Park MW, Lee SU, Kwon S, Seo KS. Comparison Between the Effectiveness of Complex Decongestive Therapy and Stellate Ganglion Block in Patients with Breast Cancer-Related Lymphedema: A Randomized Controlled Study. Pain Physician. 2019 May;22(3):255-263.