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Prevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP)

NCT02528539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-02

No results posted yet for this study

Summary

Introduction: Breast cancer women who are treated with axillary node dissection are at increased risk for lymphedema - the lifetime risk in these women is estimated at 15-50% and the risk can significantly increase with chemotherapy and radiation therapy

Objectives:

1. To evaluate the feasibility and effectiveness of implementing the integrative therapy program (ITP) intervention. ITP consists of self-management education in conjunction with acupuncture.
2. To determine if ITP affects quality of life, self-efficacy, lymphedema knowledge, pain, and early detection and management of lymphedema.

Design: the exploratory study aims to evaluate the feasibility and benefits of the integrative therapy program (ITP) intervention post-operatively for 18 months.

Subjects: Women with breast cancer treated with axillary node dissection with normal baseline pre-operative bioimpedance (L-dex U400) score.

Sample size: 30 subjects

Conditions

  • Lymphedema

Interventions

OTHER

ITP

The study participants will receive weekly acupuncture treatment plus education on self-management for 10 weeks after axillary node dissection, then a total of five follow up acupuncture treatments once every 3 months at 6, 9, 12, 15, and 18 months. The education and self management will be reinforced monthly by telephone visit. Acupuncture points include: LI 4, LV3, HT3, SP9, GB 20, KD 3, Yintang, and Ashi points

Sponsors & Collaborators

  • Huntington Memorial Hospital

    lead OTHER

Principal Investigators

  • Suzie S Kline, PhD · Huntington Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-08-30
Completion
2016-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528539 on ClinicalTrials.gov