Effectiveness of CDT for the Treatment of Lymphedema in Breast Cancer Patients Who Received LVA Surgery

NCT ID: NCT06569719

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-12-30

Brief Summary

Breast cancer is the most common type of cancer in women worldwide. Advances in treatment have increased survival rates, so patients must live with the complications resulting from the cancer and its treatment. One of the most common side effects is lymphedema, which can occur as a secondary effect of surgical or radiotherapy treatment. Lymphatic edema is a condition characterized by an excess of lymphatic fluid, rich in proteins, in the subcutaneous tissue, causing pain, a feeling of heaviness in the affected limb, restricted range of motion, and, in some cases, progressing to the formation of ulcers and recurrent infections; inevitably affecting the quality of life of the women who suffer from it. There are various therapeutic strategies to reduce the risk of developing lymphedema or to treat it. Among the management options is complex decongestive therapy (CDT), which is a conservative treatment that includes manual lymphatic drainage (MLD), compression therapy, skin care, and lymph-reducing exercises (LRE). Surgical options include lymph node transfer and lymphovenous anastomosis; redirecting lymphatic circulation and reducing edema in the affected limb. This is why the current research is undertaken, aiming to evaluate the effectiveness of combining these two treatment approaches in terms of reducing lymphedema, the presence of cellulitis, and changes in patients' quality of life

Detailed Description

Breast cancer is the most common type of cancer among women, with an estimated 2.3 million new cases diagnosed worldwide in 2020, with especially high incidence in developed countries. The five-year survival rate for breast cancer exceeds 90%, and the average ten-year survival rate for women with non-metastatic invasive breast cancer is 84% (Ferlay et al., 2021).

As a consequence, there is an increasing number of women facing early and late side effects from breast cancer treatment. One of the most common side effects is lymphedema, with a reported incidence after cancer treatment around 30% (Martínez Jaimez, 2017). In Colombia, it is estimated that 28% of women who undergo lymphadenectomy develop lymphedema (Valencia Legarda et al., 2020). Lymphedema is a chronic inflammatory disease that affects approximately 250 million people worldwide, mostly associated with cancer treatment. It can occur as a result of breast cancer surgery and/or radiotherapy (Riady-Aleuy et al., 2022). Lymphedema is defined as the accumulation of protein-rich fluid in the interstitium, secondary to abnormalities in the lymphatic transport system.

According to the impact of lymphedema on the quality of life of individuals, as well as the associated social and economic costs, efforts must be made to prevent and treat it. Various conservative strategies are used to reduce the risk of developing lymphedema and to manage it once it has developed. Among the physiotherapeutic options is complex decongestive therapy (CDT), which is a conservative treatment that includes manual lymphatic drainage (MLD), compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LRE).

Another treatment option is surgery, which has traditionally been considered a last resort when conservative measures have failed. However, increasingly advanced surgical interventions are now being performed early in the disease process, with the hope of preventing or reversing edema that arises from impaired lymphatic flow (Markkula et al., 2019). These interventions include liposuction, lymph node transfer, and lymphaticovenular anastomosis (LVA). The latter was first described in 1960, but it wasn't until 1989 in Japan and in 2020 in Colombia that it became the gold standard of microsurgery, emerging as an innovative technique in our field, increasingly used as a treatment for lymphedema rather than as a last-resort strategy when other treatments have failed (Gupta et al., 2021).

Conditions

Breast Cancer Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Patients who have recieved lymphovenous anastomosis in the past 12 months and participates in complex decongestive therapy (CDT), including all its techniques, consisting of a total of 10 therapy sessions and a follow-up at 3 months

Group Type: EXPERIMENTAL

Complex decongestive therapy

Intervention Type: OTHER

Includes manual lymphatic drainage (MLD), compression therapy (which consists of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises

Control

Patients received lymphovenous anastomosis and they are provided with compression garments as part of the treatment withot recieving CDT . This group will have an initial assessment and follow-up at 3 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Complex decongestive therapy

Includes manual lymphatic drainage (MLD), compression therapy (which consists of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with lymphedema due to cancer.
• Patients who have undergone lymphovenous anastomosis surgery in the past 12 months

Exclusion Criteria

• Decompensated heart failure
• Decompensated renal failure
• Open wounds
• Decompensated arterial insufficiencies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Universitaria Maria Cano

OTHER

Sponsor Role: lead

Responsible Party

Catalina Lopera Muñetón

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fundación Universitaria María Cano

Medellín, Antioquia, Colombia

Fundación Universitaria María cano

Medellín, Antioquia, Colombia

Countries

Colombia

Other Identifiers

013008013-2023-311

Identifier Type: -

Identifier Source: org_study_id