Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

NCT06009666

Lymphedema of Upper Arm Stiffness of Hand, Not Elsewhere Classified Evaluations, Diagnostic Self

COMPLETED

Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema

NCT04213001

Lymphedema of Upper Arm

COMPLETED NA

Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema

NCT06012786

Myofascial Pain Syndrome Breast Cancer Breast Cancer Female +3 more

COMPLETED

Ultrasonographic Evaluation of Changes After Complex Decongestive Therapy

NCT04139291

Lymphedema of Upper Arm

UNKNOWN NA

Multi-Parametric Assessment of Breast Lymphedema

NCT02724514

Breast Cancer Breast Lymphedema

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphedema of Upper Limb Breast Cancer Related Lymphedema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

stellate ganglion block in breast cancer related lymphedema

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

Group Type EXPERIMENTAL

bupivacaine and triamcinolone

Intervention Type COMBINATION_PRODUCT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bupivacaine and triamcinolone

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Marcaine Kenacort-a

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No