search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Impact of chemotherapy on muscle composition of breast cancer patients.


- candidate number12404
- NTR NumberNTR3449
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2012
- Secondary IDsNL40186.015.12 CCMO
- Public TitleImpact of chemotherapy on muscle composition of breast cancer patients.
- Scientific TitleThe impact of 18 weeks of chemotherapy-treatment with Taxotere/Adriamycin/Cyclophosphamide (TAC) on skeletal muscle composition of female breast cancer patients.
- ACRONYM
- hypothesis18 weeks of chemotherapy-treatment results in reduced muscle mass and muscle fiber cross-sectional area, reduced oxidative capacity, reduced muscle strength and increased muscle fat mass.
- Healt Condition(s) or Problem(s) studiedCancer cachexia
- Inclusion criteria1. Female breast cancer patients;
2. Age between 30-65 years;
3. 18 weeks of chemotherapy treatment with TAC.
- Exclusion criteria1. Participation in an exercise rehabilitation program during the study;
2. Chronic diseases that influence skeletal muscle characteristics, like type II diabetes mellitus, chronic obstructive pulmonary disease, chronic heart failure;
3. Chronic inflammatory disorders, like rheumatoid arthritis, colitis ulcerosa or Crohn's disease;
4. Musculoskeletal disorders that cause an inability to perform exercise.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2012
- planned closingdate31-mei-2013
- Target number of participants13
- InterventionsAll interventions will be performed before and after 18 weeks of chemotherapy:
1. Maximal strength assesment;
2. Maximal cycling test;
3. Muscle biopsy from the vastus lateralis muscle;
4. Venous blood sample;
5. Dexa scan;
6. Questionnaires regarding physical activity, dietary status and quality of life.
- Primary outcomeChanges in muscle mass, measured with dexa scan and fiber cross sectional area in muscle biopsy from the vastus lateralis muscle.
- Secondary outcome1. Changes in muscle strength;
2. Changes in endurance capacity;
3. Changes in markers of systemic inflammation and metabolism;
4. Changes in physical activity, diet and quality of life.
- TimepointsAll interventions will take place 2 weeks before the start of chemotherapy and after 18 weeks of chemotherapy.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Beelen
- CONTACT for SCIENTIFIC QUERIES M. Beelen
- Sponsor/Initiator Maxima Medisch Centrum Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD23-mei-2012 - 3-jun-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl