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

NCT02528539 | Completed

• 1 other identifier: HMH2015.002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To determine if ITP affects quality of life, self-efficacy, lymphedema knowledge, pain, and early detection and management of lymphedema.

Conditions

Lymphedema

Keywords

Prevention; lymphedema; acupuncture; self-management

Outcome Measures

Primary Outcomes (2)

• Bioimpedance (L-dex U400)

  use L-dex machine

  18 months

• Arm circumference measurements of the upper limbs using at 4 cm interval

  measure the circumference in centimeters

  18 months

Secondary Outcomes (4)

• Self-Efficacy Scale

  18 months

• Lymphedema Knowledge Scale

  18 months

• Quality of Life (Functional Assessment of Cancer Therapy-Breast)

  18 months

• Wong-Baker FACES Pain Scale

  18 months

Study Arms (1)

ITP (Integrative Thearpy Program)

EXPERIMENTAL

This ITP intervention consists of two distinct phases, Phase I, the active treatment phase and Phase II, the follow-up phase. Phase I (Intervention phase) begins post-operatively in 4-6 weeks with a baseline visit that includes 30-minute acupuncture treatment, followed by the 30-minute self-management educational session, and the participants will return weekly for 10 weeks. Phase II (Follow up phase) begins at month 6 and ends at month 18 from the surgery. The phase II consists of 1-hour quarterly ITP therapy at months 6, 9, 12, 15, and 18 and monthly telephone visits between ITP therapies at months 7, 8, 10, 11, 13, 14, 16, and 17. Self-management reinforcement and support will be implemented during telephone follow up visits

Other: ITP

Interventions

ITP OTHER

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

Also known as: Integrative Therapy Program

ITP (Integrative Thearpy Program)

Eligibility Criteria

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

You may qualify if:

• Subjects must be able to read and understand the informed consent form and have the capacity to give consent.
• Adults age 18 and older
• Subject with a newly diagnosed stage I-III breast cancer with a documented pre-operative baseline L-Dex U400 who underwent axillary lymph node dissection within 4-6 weeks prior to enrollment.
• Subjects must be able to return to the study site for the duration of the study (18 months).

You may not qualify if:

• Subjects who do not read or understand the informed consent are ineligible.
• Subjects who have any contraindications to the affected upper-limb exercises, which include congestive heart failure, cardiac arrhythmia, deep vein thrombosis, infectious disease complications such as cellulitis and lymphangitis.
• Women with double mastectomy with axillary node dissection bilaterally.
• Women with a prior history of axillary surgeries in the ipsilateral side and/or primary lymphedema
• Women with metal implants (e.g. shoulder replacement) or cardiac implants (e.g. automated implanted cardiac defibrillator (AICD) or pacemaker).
• All subjects with objective or subjective signs and symptoms of lymphedema.
• Women of childbearing age who are pregnant.

Sponsors & Collaborators

• Huntington Memorial Hospital: lead

Study Sites (1)

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Lymphedema

Interventions

Inosine Triphosphate

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Suzie S Kline, PhD

  Huntington Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, NP, LAc

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: August 1, 2013
• Primary Completion: August 30, 2015
• Study Completion: December 30, 2016
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)