Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients|
|- candidate number||28969|
|- NTR Number||NTR7247|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-mei-2018|
|- Secondary IDs||NL64685.041.18 18-136 METC UMC Utrecht |
|- Public Title||Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients|
|- Scientific Title||Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients: a follow-up of two randomized clinical trials |
|- ACRONYM||Pact-Paces-Heart study|
|- hypothesis||We hypothesize that participation in an exercise program during adjuvant chemotherapy has reduced cardiovascular toxicity toxicity in women wiht breast cancer after an average follow-up of 6 years. In addition to cardiovacular toxicity, we hypothesize that participation in an exercise program has beneficial effects on fatigue, exercise capacity, quality of life, cognitive functioning and muscle strength. |
|- Healt Condition(s) or Problem(s) studied||Physical activity, Breast cancer, Chemotherapy, Heart function, Cardiotoxicity|
|- Inclusion criteria||Patients who participated in the previous PACT or PACES study (PACT = NTR2138, PACES = NTR2159).
Both studies investigated the effects of exercising during adjuvant chemotherapy for breast cancer using comparable exercise interventions.
|- Exclusion criteria||- Participants who died during follow-up|
- Participants who are not considered eligible by their treating physician, based on psychological or physiological contraindications.
- Participants treated with chemotherapy, targeted therapy or thoracic radiotherapy after the completion of the original PACT or PACES trial for recurrent breast cancer (incl. contralateral breast cancer), metastases or a secondary malignancy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2018|
|- planned closingdate||1-dec-2019|
|- Target number of participants||180|
|- Interventions||The Pact-Paces-Heart study has no interventions. |
However, the previous PACT and PACES study both had interventions. In PACT, participants were randomized to an intervention or control arm. The invervention group underwent an 18 week supervised exercise program during adjuvant treatment, which started within six weeks after diagnosis. The control groups received care as usual. In contrast to PACT, PACES had two intervention arms and a control group. The first was Onco-Move, a low-intensity home-based exercise program. The second, On-Track, was high-intensity supervised exercise program. Control group received, comparable to PACT, care as usual.
|- Primary outcome||1. Extracellular volume fraction (ECV)as detected with cardiac MRI using quantitative mapping techniques. |
|- Secondary outcome||1. Cardiac MRI parameters other than ECV; such as LVEF and global longitudinal strain|
2. Cardiopulmonary exercise testing (CPET) parameters, including VO2 peak
3. Resting echocardiography
4. Stress echocardiography (post-exercise)
5. Endothelial function, as measured by the EndoPAT.
6. Muscle strength
7. Congitive functioning incl. self-reported cognitive complaints
8. Biochemical measurements regarding exercise-related and cardiovacular toxicity biomarkers
9. Quality of life, depression and anxiety, fatigue
|- Timepoints||Cross-sectional analysis; 1 time point. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Willeke Naaktgeboren|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Wim Groen |
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Antoni van Leeuwenhoek |
(Source(s) of Monetary or Material Support)
Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial.
BMC Medicine. 2015;13:121
van Waart H, Stuiver MM, van Harten WH, Geleijn E, Kieffer JM, Buffart LM, de Maaker-Berkhof M, Boven E, Schrama J, Geenen MM, Meerum Terwogt JM, van Bochove A, Lustig V, van den Heiligenberg SM, Smorenburg CH, Hellendoorn-van Vreeswijk JA, Sonke GS, Aaronson NK. Effect of Low-Intensity Physical Activity and Moderate- to High-Intensity Physical Exercise During Adjuvant Chemotherapy on Physical Fitness, Fatigue, and Chemotherapy Completion Rates: Results of the PACES Randomized Clinical Trial. J Clin. Oncol. 2015; 33(17):1918-27
|- Brief summary||The Pact-Paces-Heart study|
Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients: a follow-up of two randomized clinical trials
Rationale for the study:
The population of breast cancer survivors is growing rapidly as a result of aging of the population and ongoing successes in cancer treatment. Nevertheless, cancer treatment can have adverse cardiovascular side effects that impact morbidity and mortality, reducing overall quality of life of cancer survivors. While accumulating evidence suggests that physical activity during cancer treatment can be a safe, non-pharmalogical approach to migitage the cardiotoxic effects of cancer treatment, this has not been demonstrated in a large population of mid-term cancer survivors.
To explore if participation in an exercise program during adjuvant chemotherapy for breast cancer therapy has beneficial effects cardiovascular toxicitity (primary outcome), cognitive functioning, exercise capacity, endothelial function, biochemical measurements of cardiovascular toxicity, muscle strength, quality of life, fatigue and depression (secondary outcomes).
Follow-up study of two previous RCTs (the PACT and PACES study)
Participants of the previous PACT and PACES study; breast cancer survivors who underwent adjuvant chemotherapy 6 years ago. The estimated study population is 180 participants.
Participants will be invited for a study visit to undergo a series of tests, including cardiac MRI, rest and stress echocardiography, CPET, muscle test and the assessment of endothelial function. In addition, venous blood sample will be drawn. Participants will be asked to complete an online cognitive test battery and online questionnaires concering fatigue (MFI), depression and anxiety (HADS), quality of life (EORTC QLQ30), physical activity (PASE/SQUASH), self-reported cognitive complaints (MDASI) and the presence of cardiovascular risk factors.
|- Main changes (audit trail)|
|- RECORD||30-mei-2018 - 10-jun-2018|
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