Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema

NCT04165512 | Unknown

• 1 other identifier: 09.2019.984
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 .

Conditions

Lymphedema of Upper Limb; Breast Cancer Related Lymphedema

Keywords

lymphedema; breast cancer; stellate ganglion; treatment; ultrasound

Outcome Measures

Primary Outcomes (20)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (8)

• Activity and participation - Quick-DASH

  before treatment (T0)

• Activity and participation - Quick-DASH

  2nd week of treatment (T1)

• Activity and participation - Quick-DASH

  4th week of treatment (T2)

• Activity and participation - Quick-DASH

  3rd month of treatment (T3)

• Quality of life - Lymphedema Life Impact Scale

  before treatment (T0)

Study Arms (1)

stellate ganglion block in breast cancer related lymphedema

EXPERIMENTAL

US-guided stellat ganglion block will be applied to the patients with breast cancer related lymphedema twice at two-week intervals.

Combination Product: bupivacaine and triamcinolone

Interventions

bupivacaine and triamcinolone COMBINATION_PRODUCT

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

Also known as: Marcaine, Kenacort-a

stellate ganglion block in breast cancer related lymphedema

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Canan Şanal-Toprak

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 28018504 BACKGROUND

• 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.

  PMID: 25589949 BACKGROUND

• 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.

  PMID: 25577504 BACKGROUND

• 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.

  PMID: 25675063 BACKGROUND

• 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.

  PMID: 31151333 BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema; Breast Neoplasms

Interventions

Bupivacaine; Triamcinolone

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Gülseren Akyüz, Prof

  Marmara University

  STUDY CHAIR

• Canan Şanal-Toprak, Asst. Prof

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 18, 2019
• Study Start: January 7, 2020
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)