Efficacy of Home-based Treatment for Breast Cancer-related Lymphedema

NCT06783543 | Active Not Recruiting DMC

• 1 other identifier: yan2024-1125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trials is to explore the effectiveness of home-based iymphedema treatment and the differences between the home-based and outpatient treatment. The main question is to verify that home-based treatment is as effective as outpatient treatment. We set two groups in this study, comparing the volume of affected upper limb to see if home-based iymphedema treatment is valuable method.

Conditions

Lymphedema Arm

Keywords

lymphedema; breast cancer; Manual therapy; home-based therapy

Outcome Measures

Primary Outcomes (1)

• the volum of affected arm

  A soft ruler was used to measure the patient's wrist stripes and 10cm, 20cm, 30cm and 40cm above the wrist stripes, respectively, to obtain the circumference value. The five measurement points can divide the limb into four truncated cones, and then the formula can be used to calculate the volume of each limb segment, in which C1 and C2 are the arm circumference of the upper and lower two points of the measurement segment. h is the length of the measuring section, that is, 10 cm, and the whole limb volume is the sum of the volumes of each section.

  at the first day and after one month

Secondary Outcomes (2)

• Quality of life Core questionnaire scale -- EORTC QLQ-C30

  at the first day and after one month

• Breast Cancer and Lymphedema Symptom Experience Index， BCLE-SEI

  at the first day and after one month

Study Arms (2)

home-based group

EXPERIMENTAL

In this group of patients, the therapist conducted standardized comprehensive detumescence treatment at the first treatment which including four steps of skin care, manual lymphatic drainage, low-elastic bandage dressing and functional exercise. After the treatment, videos of manual lymphatic drainage and pressure dressing of family members were provided. Patients or family members were required to perform this treatment at home every day. Video recordings were necessary during treatment at home which were required be sent to the therapist, making sure the session is done every day. They returned to the edema clinic one month later for another evaluation. If patients encounter problems that cannot be solved during home treatment, they should consult online on wechat, or return to the edema clinic in time.

Other: Comprehensive detumescence treatment with education video

outpatient group

ACTIVE COMPARATOR

Patients were required to go to the lymphedema clinic for comprehensive detumescence treatment, including skin care, manual lymphatic drainage, low-elastic bandaging and functional exercise, 3 to 5 times a week for 1 hour each time. They were re-evaluated after one month of treatment.

Other: Comprehensive detumescence treatment

Interventions

Comprehensive detumescence treatment with education video OTHER

Comprehensive detumescence treatment, including skin care, manual lymphatic drainage, low elastic bandaging and functional exercise four steps

Also known as: Education video of manual lymphatic drainage and pressure bandaging

home-based group

Comprehensive detumescence treatment OTHER

Three to five times a week, one hour each time

outpatient group

Eligibility Criteria

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

You may qualify if:

• Lymphedema appeared in the upper limb after breast cancer-related treatment, and compared with the healthy side, the edema dimension was more than 2cm.
• Age 18-75 years old;
• Edema stage Ⅰ to Ⅱ;

You may not qualify if:

• People with severe cognitive impairment;
• Bilateral lymphedema;
• Patients undergoing radiotherapy；
• Patients with uncontrolled tumors;
• Congestive heart failure and other comprehensive detumescence treatment contraindicated patients.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: According to the computer random number method, the enrolled patients were divided into home treatment group and outpatient treatment group, 20 cases each.

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 20, 2025
• Study Start: November 13, 2024
• Primary Completion: November 13, 2025
• Study Completion: December 13, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)