Patients receiving adjuvant chemotherapy who are at risk of developing breast cancer related arm lymphedema Cancer Breast cancer
Conditions
Interventions
After obtainment of signed consent and screening for breast cancer related arm lymphoma, participants will be randomized with an allocation of a 1:1 ratio to partake in either the heavy or low load ex
Sponsors
University Hospitals Centre for Health Research (Denmark)
Eligibility
Sex/Gender
Female
Inclusion criteria
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. Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 16/10/2017: Extracellular fluid (L-Dex) is measured using Bioimpedance spectroscopoy at pre-exercise, post- exercise, 24 hrs post-exercise, 72 hrs post-exercise Previous primary outcome measures: 1. Measurement outcomes will be recorded just prior to and after the experimental RT sessions, and again after 24 and 72 hours and will be performed with no knowledge of exercise allocation at the Clinical Nuclear and Physiological Department, Rigshospitalet. 2. Extracellular fluid: BIS directly measures extracellular fluid and therefore has a high reliability for detecting BCRL development as it initially is characterized by an excess of extracellular fluid. BIS will be applied to measure the impedance of extracellular fluid for each limb at a range of frequencies assessed using the manufacturer’s software (SFB7, Impedimed, Brisbane, Australia). The ratio of impedance values between the limb at risk and non-affected limbs, will be calculated and converted into a lymphedema index (L-Dex) score. An increase in a L-Dex score denotes an increase in extracellular fluid. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/10/2017: 1. Inter-arm volume difference (%) is measured using Dual X-ray absorptiometry at pre-exercise, post- exercise, 24 hrs post-exercise, 72 hrs post-exercise 2. Breast cancer-related symptoms (heaviness, swelling, tightness, pain) is measured using a numeric rating scale (0 (no discomfort) -10 (severe discomfort)) at pre-exercise, post- exercise, 24 hrs post-exercise, 72 hrs post-exercise Previous secondary outcome measures: 1. Arm volume: DXA (Lunar Prodigy Advanced scanner, GE Healthcare, Madison, WI,) assesses tissue composition (lean mass, bone mineral content, fat mass) of the limbs using a three compartment model that is sensitive to changes in upper limb tissue composition and upper limb volume and is considered safe and easy to perform. Subjects will be positioned on the scan table lying supine and with the arm separated from the trunk. Each arm will be scanned. Software version (Small animal program version 8.1027) will be used to analyze the scans. Using previously derived densities for: fat (0.9 gm/ml); lean mass (1.1gm/ml); bone mineral 1.85 gm/ml), the measured DXA tissue weights will be transformed into estimated volumes using the following equation: v=m/d where v=volume and d=density. 2. Subjective assessment of symptoms: Symptom response to the training bouts will be monitored using the visual analogue scale (VAS). VAS will be used to quantify the severity of perceived swelling, heaviness, pain and tightness in both the non-affected limb and the limb at risk. Participants will rate their symptom severity from no discomfort (VAS=0) to very severe/worst imaginable discomfort (VAS=10). | — |
Countries
Denmark
Outcome results
None listed