Clinical trial NCT05297643: Effects of Extracorporeal Shock Wave Therapy Added To Complex DecongestiveTherapy In Patıent With Lymphedeme
Official title: Effects of Extracorporeal Shock Wave Therapyy Added To Complex DecongestiveTherapy In Patient With Breast Cancer Releated Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema, Breast Cancer
Keywords: Lymphedema
Complex DecongestiveTherapy
Extracorporeal Shock Wave Therapy
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trials
Primary purpose: TREATMENT

Brief summary: Extracorporeal Shock Wave Therapy (ESWT); It is a treatment method in which high-intensity pressure waves are applied to the desired point in the body. It has been used in the treatment of kidney stones in previous years, and changes in bone tissue have been observed . Today, it is used in musculoskeletal diseases such as plantar fasciitis, epicondylitis, achillestendinitis, and osteoarthritis. The main mechanism of action of ESWT is not clearly known, but many studies have shown that it stimulates the early release of angiogenesis-related growth factors such as endothelial nitric oxide synthase (eNOS) and vascular endothelial growth factor (VEGF) and increases blood circulation with induced neovascularization, resulting in cell proliferation and tissue growth. It has been shown to increase regeneration . It has been found to be effective in lymphedema with neovascularization and lymphatic channel synthesis . In the literature, there are studies investigating the additional contributions of complex decongestive therapy combined with ESWT in patients with lymphedema.

Detailed description: Breast cancer is the most common cancer in women and the leading cause of death in the world. With the advances in early diagnosis and treatment methods, the mortality rate in breast cancer tends to decrease . However, some complications secondary to both the disease and the treatment can be seen in patients who have received treatment. Examples of these complications are; functional disability, advanced peripheral neuropathy secondary to chemotherapy agents, pain, weight loss or weight gain, depression, lymphedema. lymphedema; It is primarily a condition characterized by abnormal accumulation of fluid in the subcutaneous tissue and subfascial layer. Lymphedema occurs as a result of fluid accumulation above the lymphatic carrying capacity or insufficient lymphatic transport. Lymphedema is a chronic progressive disease. Therefore, early diagnosis and treatment are important to prevent complications (disability, infection, depression, pain, malignant transformation).

Lymphedema secondary to breast cancer was first defined as postmastectomy lymphedema by Hastead in 1921. Treatment of secondary lymphedema is multidisciplinary. The gold standard method is complex decongestive therapy (CDT). It consists of two phases. Phase 1: lasting 2-6 weeks; manual lymphatic drainage (MLD), multilayer bandaging, exercise and skin care. With MLD treatment, fluid is removed and bandaging is applied to prevent re-accumulation. Exercise and skin care are explained to the patient. When the plateau phase is reached in the measurements, the protection phase is started. Phase 2: includes self-massage, exercise, skin care, bandaging and the use of compression garments. Apart from these; Low-dose laser, oral medications, pneumatic compression devices and surgical methods can be used in the treatment of lymphedema. In this study, both groups will receive MLD treatment. In other words, no group will be left without treatment.

Extracorporeal Shock Wave Therapy (ESWT); It is a treatment method in which high-intensity pressure waves are applied to the desired point in the body. It has been used in the treatment of kidney stones in previous years, and changes in bone tissue have been observed. Today, it is used in musculoskeletal diseases such as plantar fasciitis, epicondylitiS and osteoarthritis. The main mechanism of action of ESWT is not clearly known, but many studies have shown that it stimulates the early release of angiogenesis-related growth factors such as endothelial nitric oxide synthase (eNOS) and vascular endothelial growth factor (VEGF) and increases blood circulation with induced neovascularization, resulting in cell proliferation and tissue growth. It has been shown to increase regeneration . It has been found to be effective in lymphedema with neovascularization and lymphatic channel synthesis . In the literature, there are studies investigating the additional contributions of complex decongestive therapy combined with ESWT in patients with lymphedema. While planning this study, the dose and duration of ESWT were determined based on these studies.

Eligibility criteria: Inclusion Criteria:

1. Be over 18 years old
2. History of lymphedema for at least 6 months after breast cancer treatment
3. Ending radiotherapy treatment at least 2 months ago
4. Not being included in the Complex DecongestiveTherapy program within 3 months
5. Having unilateral lymphedema
6. Having stage 2 lymphedema
7. Signing of the voluntary consent form
8. Patients who have undergone oncological follow-up for breast cancer in the last 6 months and have been shown to be free of recurrence and metastasis

Exclusion Criteria:

1. Active cancer
2. Skin infection, radiotherapy burn
3. Severely affected upper extremity range of motion 4 kidney failure

5. Heart failure 6. History of untreated deep venous thrombosis 7. Body mass index I≥35 kg/m2 8. Using a pacemaker/internal defibrillator 9. Patients continuing radiotherapy and/or chemotherapy treatment 10. Having bilateral lymphedema 11. Pregnancy

Primary outcomes:
measure: Evaluation of Pain;
timeFrame: Baseline
measure: Evaluation of Pain;
timeFrame: 3th week (after treatment)
measure: Evaluation of Pain;
timeFrame: 12th week
measure: Environmental Measurement;
timeFrame: Baseline
measure: Environmental Measurement;
timeFrame: 3th week (after treatment)
measure: Environmental Measurement;
timeFrame: 12th week
Secondary outcomes:
measure: Shoulder and Hand Questionnaire (Quick-DASH)
timeFrame: Baseline
measure: Shoulder and Hand Questionnaire (Quick-DASH)
timeFrame: 3th week (after treatment)
measure: Shoulder and Hand Questionnaire (Quick-DASH)
timeFrame: 12th week
measure: Measurement of Joint Range of Motion:
timeFrame: Baseline
measure: Measurement of Joint Range of Motion:
timeFrame: 3th week (after treatment)
measure: Measurement of Joint Range of Motion:
timeFrame: 12th week
measure: Grip Strength:
timeFrame: Baseline
measure: Grip Strength:
timeFrame: 3th week (after treatment)
measure: Grip Strength:
timeFrame: 12th week
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University Faculty of Medicine
state: City Center
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: Basak Cigdem Karacay, Asst Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cebicci MA, Sutbeyaz ST, Goksu SS, Hocaoglu S, Oguz A, Atilabey A. Extracorporeal Shock Wave Therapy for Breast Cancer-Related Lymphedema: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1520-1525. doi: 10.1016/j.apmr.2016.02.019. Epub 2016 Mar 15.
citation: Lee KW, Kim SB, Lee JH, Kim YS. Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema. Ann Rehabil Med. 2020 Oct;44(5):386-392. doi: 10.5535/arm.19213. Epub 2020 Sep 28.
citation: Joos E, Vultureanu I, Nonneman T, Adriaenssens N, Hamdi M, Zeltzer A. Low-Energy Extracorporeal Shockwave Therapy as a Therapeutic Option for Patients with a Secondary Late-Stage Fibro-Lymphedema After Breast Cancer Therapy: A Pilot Study. Lymphat Res Biol. 2021 Apr;19(2):175-180. doi: 10.1089/lrb.2020.0033. Epub 2020 Aug 11.
citation: Bae H, Kim HJ. Clinical outcomes of extracorporeal shock wave therapy in patients with secondary lymphedema: a pilot study. Ann Rehabil Med. 2013 Apr;37(2):229-34. doi: 10.5535/arm.2013.37.2.229. Epub 2013 Apr 30.