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

NCT06569719 | Completed DMC

• 1 other identifier: 013008013-2023-311
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (1)

• Lymphedema change

  Upper and leg Extremity Lymphedema Index. The index includes 5 perimeters that are sum and divided by BMI. Classified as mild leg lymphedema \< 250, mild to severe 250-350 and severe \> 350. Classified as mild arm lymphedema \< 130, mild to severe 130-150 and severe \> 150 This outcome is compound by multiple measurements that will be aggregated to arrive at one reported.

  Baseline, post-intervention up to 3 weeks and 3 months follow up

Secondary Outcomes (1)

• Quality of life change

  Baseline, post-intervention up to 3 weeks and 3 months follow up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Complex decongestive therapy

Control

NO INTERVENTION

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

Interventions

Complex decongestive therapy 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

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion Universitaria Maria Cano: lead

Study Sites (2)

Fundación Universitaria María Cano

Medellín, Antioquia, 0000, Colombia

Location

Fundación Universitaria María cano

Medellín, Antioquia, 05000, Colombia

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 26, 2024
• Study Start: February 1, 2024
• Primary Completion: August 14, 2024
• Study Completion: December 30, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 12 months after article publication and the data will made accessible for up to 18 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact catalinaloperamuneton@fumc.edu.co

Locations

CO (2)