Status:
TERMINATED
Cancer Adverse Effects PReventIon With Care & Exercise: the CAPRICE Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Spital STS AG
Bürgerspital Solothurn
Conditions:
Breast Neoplasm Female
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Breast cancer is the most common cancer among women worldwide. Similarly, Hodgkin and non- Hodgkin lymphomas make up two of the most prevalent cancers in men and women. Even though remarkable improvem...
Detailed Description
Study Design: A single-center, two-arm, parallel group with standard of care controlled trial with a balanced 1:1 randomization will be conducted at University Hospital Inselspital, Berne, Switzerland...
Eligibility Criteria
Inclusion
- Women and men aged 18 years and older
- Histologically confirmed breast cancer or lymphoma
- Anth-bC naïve
- Scheduled for first-line Anth-bC
- Eastern Cooperative Oncology Group (ECOG) grade 0-2
- Curative or palliative approach with reasonable life expectancy
- Willingness to attend exercise sessions twice per week for 12 weeks (24 sessions in total)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Exclusion
- Inability to participate in a 3-month training program
- Contraindication to maximal CPET
- Cancer-specific contraindications including safety blood parameters
- Previous radiotherapy of the mediastinum and/or the the left breast
- Structural heart disease with reduced left ventricular ejection fraction (EF\<50%)
- Valvular heart disease with more than mild regurgitation or stenosis
- Heart rhythms other than sinus rhythm
- Pacemaker with permanent ventricular stimulation
- Antihypertensive medication (e.g. ACE inhibitors/ATII blockers, Ca channel blocker, beta blockers)
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03850171
Start Date
May 1 2019
End Date
January 31 2023
Last Update
February 27 2023
Active Locations (4)
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1
Lindenhofgruppe
Bern, Switzerland, 3001
2
University Clinic for Cardiology
Bern, Switzerland, 3010
3
Bürgerspital Solothurn
Solothurn, Switzerland, 4500
4
Spital STS AG
Thun, Switzerland, 3600