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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Page 1 of 1 (4 locations)

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