A prospective study of the effect of chemotherapy on metabolic and cardiovascular function in women with early stage breast cancer

Not Applicable

Completed

• Conditions: Early stage breast cancer; Cancer - Breast

• Registration Number: ACTRN12614001055695
• Lead Sponsor: A/Prof Bogda Koczwara

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-03
• Study Completion: 2019-08-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

1.Female with histologically proven invasive breast cancer
2.American Joint Committee on Cancer (AJCC) Tumour Node Metastasis (TNM) Stage I - III disease
3.Age equal to or greater than 18 years
4.To commence adjuvant chemotherapy for breast cancer
5.ECOG Performance Status 0-2

Inclusion criteria for age and gender matched controls
1.Female
2.Age within 5 years of matched patient’s age
3.No current or previous diagnosis of cancer

Exclusion Criteria

1.Current use of insulin or oral hypoglycaemic agents
2.Current use of beta blockers
3.Current use of antiplatelets/anticoagulants including aspirin, clopidogrel, warfarin, heparin
4.Presence of atrial fibrillation
5.Diagnosis of Raynaud’s syndrome
6.History of claustrophobia
7.Medical or psychiatric condition that compromises the subject’s ability to give informed consent
8.Difficult venous access
9.Large chest wall seroma

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change in pulse wave velocity from baseline test to post chemotherapy testing.<br>Pulse wave velocity (PWV) <br>PWV will also be performed to quantify arterial stiffness. A Sphygmocor device and electrocardiography will be used to measure the velocity of pressure waves at the carotid and femoral arteries. <br>It will take approximately 30 minutes to perform PWA and PWV testing. <br>[Nine months.]

Secondary Outcome Measures

Name	Time	Method
Changes in established markers of cardiovascular function.<br><br>Established markers of cardiovascular function <br>a. arterial stiffness using pulse wave analysis and pulse wave velocity <br>b. sympathetic nervous system function using spontaneous baroreceptor activity <br>c. endothelial function using finger arterial pulsatile volume changes <br>d. inflammation using blood markers, including C-Reactive Protein (CRP) and interleukins using measurements of levels in the serum<br>[9 months];Changes in markers of energy balance.<br><br>markers of energy balance <br>a. caloric intake using multiple pass recall methodology <br>b. resting energy expenditure using indirect calorimetry <br>c. diet-induced thermogenesis using indirect calorimetry <br>d. physical exercise using the International Physical Activity Questionnaire <br>[9 months]