Clinical Trials Logo

Clinical Trial Summary

The aim of this observational study is to investigate the association between mid-life changes in cardiorespiratory fitness and the risk of breast cancer incidence and mortality among Swedish women. The main questions to answer are: - Are changes in cardiorespiratory fitness associated with the risk of being diagnosed or dying from/with breast cancer later in life? Participants performed at least two occupational health assessment tests, which consisted of a submaximal ergometer cycle test, measurement of body mass and height to calculate BMI, and a questionnaires on physical and life style habits.


Clinical Trial Description

PLAN FOR THE STATISTICAL ANALYSES This plan has been made before any data analysis has been conducted. The primary statistical analysis aims to determine if there is any association between changes in estimated cardiorespiratory fitness (both absolute L/min and relative ml/min/kg) and breast cancer incidence and mortality. Cox proportional hazards models will be analysed with inverse probability treatment weights of time-varying confounders such as BMI, physical activity smoking and alcohol. Time stable confounders will be baseline cardiorespiratory fitness, education, co-morbidities. Risk time will be calculated as the time from last cardiorespiratory fitness test to the diagnosis of breast cancer or the end of study. In addition, restricted cubic splines will be performed. Secondary analysis will be performed to determine if the association remains after dividing into prespecified groups. The first analysis will be conducted by grouping individuals who decrease, stay stable or increase in cardiorespiratory fitness. The second analysis, we will conduct is an analysis to investigate if age (proxy for menopausal status) modifies the relationships between change in cardiorespiratory fitness and breast cancer incidence or mortality. This will be performed in two analyses by splitting on age 50 and 60, respectively. In the third analysis we will investigate if baseline fitness modifies the association. This will be done with fitness both as a continuous and stratified into tertiles. Proportional hazard assumption was checked using scaled Schönfelts residuals. Analysis will include four models and include confounders relevant to the outcomes and research questions. These will be as follows: Model 1: Baseline cardiorespiratory fitness Model 2: Baseline cardiorespiratory fitness, age, education and date of last health assessment test Model 3: Baseline cardiorespiratory fitness, age, education and date of last health assessment test, BMI Model 4: Baseline cardiorespiratory fitness, age, education and date of last health assessment test, BMI, physical activity, smoking and alcohol intake. Sensitivity analysis: To address potential reverse causality we will exclude individuals who are diagnosed with breast cancer within two years after the last health assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05729451
Study type Observational [Patient Registry]
Source The Swedish School of Sport and Health Sciences
Contact
Status Completed
Phase
Start date January 1, 1990
Completion date December 31, 2019

See also
  Status Clinical Trial Phase
Withdrawn NCT03285607 - MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer Phase 1
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Withdrawn NCT05191004 - Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC Phase 1/Phase 2
Completed NCT01271738 - Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer N/A
Terminated NCT02669914 - MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors Phase 2
Completed NCT01980823 - Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer Early Phase 1
Completed NCT02658708 - Bright Light on Fatigue in Women Being Treated for Breast Cancer Phase 1
Completed NCT02891681 - Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment N/A
Completed NCT05584644 - A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
Recruiting NCT05252390 - NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03084536 - PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery Phase 2
Terminated NCT02907918 - Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer Phase 2
Completed NCT03007979 - Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer Phase 2
Terminated NCT02462200 - Shave Margins in Breast Conservation Therapy Phase 2
Completed NCT03592121 - Study to Investigate the Effect of AB-101 in Breast Cancer Survivors Early Phase 1
Terminated NCT02642094 - Aging Mammary Stem Cells and Breast Cancer Prevention Phase 2
Active, not recruiting NCT04855552 - Telehealth Weight Loss Program for Breast Cancer Survivors N/A
Active, not recruiting NCT05364450 - Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors N/A
Completed NCT03494400 - Aerobic Training in Treatment for Breast Cancer N/A
Terminated NCT02375048 - Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI Phase 2