A trial to detect differences in arm volume after heavy and low load resistance exercise among patients receiving adjuvant chemotherapy for breast cancer at risk for arm lymphedema

Completed

• Conditions: Patients receiving adjuvant chemotherapy who are at risk of developing breast cancer related arm lymphedema; Cancer; Breast cancer

• Registration Number: ISRCTN97332727
• Lead Sponsor: niversity Hospitals Centre for Health Research (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

A convenience sample of patients with breast cancer will be identified from a waiting list to Body and Cancer”, a six week exercise program for cancer patients in chemotherapy in the Copenhagen area. Patients are eligible for Body and Cancer” if they have a diagnosis of cancer, have received at least one cycle of chemotherapy for advanced disease or as adjuvant treatment, have a WHO performance status of 0 or 1 and otherwise have been approved to participate by the treating oncologist. Eligible participants will be invited to be screened for BCRL using BIS and DXA and will be inspected for signs of swelling by the applicant. An L-Dex score of 10 or greater, or a volume difference between the affected and non-affected limb of 5% or more; swelling or obscuration of anatomic architecture on close inspection; pitting edema, will be defined as BCRL according to CTC v3.0 Lymphedema Criteria.

1. Patients over 18 years of age who have undergone unilateral breast surgery for breast cancer (stage l-lll) with AND beyond the sentinel node
2. Currently receiving standard adjuvant chemotherapy

Exclusion Criteria

1. A diagnosis of BCRL as defined above
2. Currently receiving treatment for lymphedema
3. Conditions hampering RT of the upper extremities
4. Previous treatment for breast cancer
5. Participated in regular RT (2x/week) of the upper extremities during the last month

Study & Design

• Study Type: Interventional
• Study Design: Not specified