Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema

Lymphedema of Upper Limb Clinical Trial

Official title:

Ultrasonographic Evaluation of the Effectiveness of Stellate Ganglion Block in Patients With Breast Cancer Related Lymphedema

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04165512
• Other study ID #: 09.2019.984
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: April 2020

Study information

• Verified date: January 2020
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Ganglion Cysts
• Lymphedema
• Lymphedema of Upper Limb

Intervention

Combination Product:
• bupivacaine and triamcinolone
a mixture of 4 mL 0.5% bupivacaine (marcaine) and 1 mL 40 mg triamcinolone (kenacort-a)

Locations

Country	Name	City	State
Turkey	Canan Sanal-Toprak	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm circumference difference	Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities.	before treatment (T0)
Primary	Arm circumference difference	Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities.	2nd week of treatment (T1)
Primary	Arm circumference difference	Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities.	4th week of treatment (T2)
Primary	Arm circumference difference	Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities.	3rd month of treatment (T3)
Primary	Subcutaneous echogenicity grade (SEG)	SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity	before treatment (T0)
Primary	Subcutaneous echogenicity grade (SEG)	SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity	2nd week of treatment (T1)
Primary	Subcutaneous echogenicity grade (SEG)	SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity	4th week of treatment (T2)
Primary	Subcutaneous echogenicity grade (SEG)	SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity	3rd month of treatment (T3)
Primary	Subcutaneous echo-free space (SEFS) grade	SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (=45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.	before treatment (T0)
Primary	Subcutaneous echo-free space (SEFS) grade	SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (=45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.	2nd week of treatment (T1)
Primary	Subcutaneous echo-free space (SEFS) grade	SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (=45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.	4th week of treatment (T2)
Primary	Subcutaneous echo-free space (SEFS) grade	SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (=45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.	3rd month of treatment (T3)
Primary	shoulder range of motion (ROM) will be evaluated with a goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation.	before treatment (T0)
Primary	shoulder range of motion (ROM) will be evaluated with a goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation.	2nd week of treatment (T1)
Primary	shoulder range of motion (ROM) will be evaluated with a goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation.	4th week of treatment (T2)
Primary	shoulder range of motion (ROM) will be evaluated with a goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation.	3rd month of treatment (T3)
Primary	Pain, tightness and heaviness sensation	Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)	before treatment (T0)
Primary	Pain, tightness and heaviness sensation	Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)	2nd week of treatment (T1)
Primary	Pain, tightness and heaviness sensation	Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)	4th week of treatment (T2)
Primary	Pain, tightness and heaviness sensation	Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)	3rd month of treatment (T3)
Secondary	Activity and participation - Quick-DASH	Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al.	before treatment (T0)
Secondary	Activity and participation - Quick-DASH	Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al.	2nd week of treatment (T1)
Secondary	Activity and participation - Quick-DASH	Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al.	4th week of treatment (T2)
Secondary	Activity and participation - Quick-DASH	Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al.	3rd month of treatment (T3)
Secondary	Quality of life - Lymphedema Life Impact Scale	Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Degirmenci et al.	before treatment (T0)
Secondary	Quality of life - Lymphedema Life Impact Scale	Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Degirmenci et al.	2nd week of treatment (T1)
Secondary	Quality of life - Lymphedema Life Impact Scale	Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Degirmenci et al.	4th week of treatment (T2)
Secondary	Quality of life - Lymphedema Life Impact Scale	Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Degirmenci et al.	3rd month of treatment (T3)