Breast CancerNCT06497322
Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment
A study testing Exercise intervention - High intensity interval training on a cycle-ergometer in people with Breast Cancer and Triple Negative Breast Cancer, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
In this randomized, controlled, prospective, two-arm intervention study, the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Exercise intervention - High intensity interval training on a cycle-ergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of histologically verified triple-negative breast cancer (TNBC) measurable by ultrasound imaging
- Stage of disease: T1c and nodal status N1-2 or Stage T2-4 and nodal status N0-2
- Deemed eligible for intended treatment with Paclitaxel 80mg/m2 q1w x12, Carboplatin 1,5 AUC q1w x12, Pembrolizumab 200mg q3w x4 followed by Epirubicin 90mg/ m2 q3w x 4, Cyclophosphamid 600mg m2 q3w x 4, Pembrolizumab 200mg q3w x 4; by the treating physician
- Treatment in curative intent with life expectancy ≥ 3 months
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.
- Sufficient German language skills;
Who cannot join
- History of invasive malignancy ≤2 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Any history of previous systemic treatment for TNBC;
- Any diseases that do not allow sports activity, such as:
- Clinically-manifest heart failure (NYHA III-IV);
- Respiratory partial or global insufficiency;
- Permanent thrombocytopenia <10,000/µl, e.g., refractory autoimmune thrombocytopenia;
Show all 9Show fewer
- Congenital or acquired thrombocytopathies or coagulation disorders.
- Symptomatic CHD (clearance certificate required, stress ECG and cardiac ultrasound recommended if necessary);
- Participation in another exercise study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Damir Zubac, PhD contact
Germany1 site
University Hospital of Cologne and St. Elizabeth Hospital
Cologne, North Rhine-Westphalia, 50937
Damir Zubac, PhD, 0221 478-97185, damir.zubac@uk-koeln.de
Freerk T baumann, PhD, freerk.baumann@uk-koeln.de
About this study
Official title: Effectiveness of High-intensity Interval Training During Neoadjuvant Immunochemotherapy on Complete Remission in Patients With Triple-negative Breast Cancer
In this randomized, controlled, prospective, two-arm intervention study, the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative breast cancer. Breast cancer is one of the most common cancers and one of the leading causes of cancer-related deaths worldwide. Among the different subtypes, triple-negative breast cancer accounts for about 15-20% of all breast cancer cases and is characterized by a more aggressive clinical course. Recent results indicate that the percentage of patients with a pathologic complete response was 13% higher in the chemotherapy-immunotherapy group (by 64.8%) than in the placebo-chemotherapy group (51.2). High-intensity interval training has a positive effect on the immune system, suggesting that it may improve the efficacy of chemo-immunotherapy, leading to a higher rate of pathologic complete response (pCR) in patients with newly diagnosed triple-negative breast cancer. In addition to the immunomodulatory effects, this exercise model could boost microvascular perfusion, thereby improving tumor perfusion, enhancing chemo-immunotherapy and leading to better outcomes.
Read the detailed description
Recent clinical trials showed promising results in patients with triple negative breast cancer (TNBC) who received four cycles of pembrolizumab (at a dose of 200 mg) every three weeks + standard chemotherapy, compared to patients who received placebo + chemotherapy alone. Importantly, the overall risk of disease progression that precluded surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause was 37% lower with pembrolizumab chemotherapy compared to placebo chemotherapy. Exercise training is a supportive multi-effect strategy with the ability to influence multiple organ systems. There is growing epidemiologic evidence that a physically active lifestyle is associated with a lower risk of developing cancer, particularly colon and breast cancer. Recent preclinical studies suggest that exercise can control and attenuate the growth of tumor cells. Therefore, exercise could be a potential means to increase the rate of pCR in cancer patients in general. High-intensity interval training resulted in higher cardiorespiratory fitness levels, particularly in breast cancer and lung patients who exercised for at least 8 weeks, with a significant improvement (from 2.40 to 4.19 mL-min-1-kg-1) observed compared to control groups. The aim of this study is to investigate the effects of HIIT training on immune system response and pCR rates (most commonly defined as complete eradication of the tumor as a surrogate parameter for good prognosis) during neoadjuvant immunochemotherapy in women with TNBC. The working hypothesis is that HIIT training would activate the immune system and enhance the combination of neoadjuvant treatment, leading to higher rates of pCR in the aerobic group compared to the usual treatment group. Thus, this exercise model may also promote microvascular perfusion, improve tumor perfusion, and potentially lead to more favorable outcomes in neoadjuvant therapy, increasing the efficacy of systemic treatments and allowing for better therapeutic outcomes. The researchers support the idea that high-intensity aerobic exercise may at least partially challenge the large heterogeneity in response to medical treatment in women with a first diagnosis of TNBC and lead to higher response rates in the experimental group.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Exercise intervention - High intensity interval training on a cycle-ergometer
- Keywords
- Exercise, Immunotherapy, Oxygen uptake, CT scan, Blood markers
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise intervention - High intensity interval training on a cycle-ergometerOther
The experimental group starts with 5 minutes of unloaded cycling, followed by 3 × 3-minute HIIT training sequences alternating between: i) 30 seconds at 90% of maximal PO (70 rpm for 30 seconds) and ii) 30 seconds of light pedaling at 20% of PO). Recent work suggests that this high-intensity approach to aerobic exercise is feasible and safe, even during acute oncology treatment. The HIIT sequences are interspersed with two 3-minute cycling sessions at moderate intensity. The training session will be concluded with a 5-minute cool-down by cycling (light pedaling) and stretching. This protocol will be performed twice a week throughout the study, and all patients who reach an 80% adherence threshold for the exercise intervention will be included in the final analysis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All women in the experimental group receive standardized high-intensity interval training over a period of 6 months in combination with neoadjuvant therapy (immunochemotherapy). The individual training sessions are guided and monitored by qualified exercise therapists, taking into account the side effects of ongoing treatment. Each training session will last about one hour, with the effective training time being 30 minutes. Bike training begins 1 hour before neoadjuvant therapy and then at the same time of day between therapies. The TNBC patients start with 5 minutes of cycling followed by 3 × 3 - minute HIIT training sequences, constantly alternating: i) 30 s at 90% of maximal PO (70 rpm for 30 s) and ii) 30 s of light pedaling at 20% of PO). The training session will be concluded with a 5-min cool-down cycling (easy pedaling) and stretching. This protocol will be performed twice a week throughout the study. Receives: Other: Exercise intervention - High intensity interval training on a cycle-ergometer |
| Control group | No intervention | The control group will receive the standard care during their neoadjuvant therapy (immunochemotherapy) over a 6-month period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission of the tumor (pCR);
The absence of residual invasive cancer of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system)
Measured: After completion of neoadjuvant therapy and after surgery (6 months from study onset)
Secondary outcomes (6)
Mamma- Ultrasound (the overall response rate of tumor mass);
Ultrasound imaging
Measured: Baseline (prior to any data collection or therapy administration), and every three weeks during neoadjuvant chemotherapy
Progression free survival and Overall survival
Clinically relevant data
Measured: Epidemiological data collected during the study and three years afterwards
Cardiorespiratory fitness
Measures of oxygen uptake via CPET
Measured: At baseline (prior to any data collection or therapy administration), three months after baseline, and six months after baseline (following completion of neoadjuvant therapy)
OCTA - optical coherence tomography angiography
Measure of blood vessel compliance for the eye
Measured: At baseline (prior to any data collection or therapy administration) and after the completion of neoadjuvant therapy (most commonly 6 months)
Biomarkers of immune response
Blood sampling to measure i) Longitudinal dynamics of soluble biomarkers such as e.g. CRP (mg/dL); ii) Longitudinal dynamics of blood counts such as e.g. leukocytes (cells/uL); iii) Longitudinal dynamics of immune cell subsets measured by flow-cytometry such as e.g. activated T-cells (CD8+HLA-DR+)
Measured: At baseline (prior to any data collection or therapy administration) and after the completion of neoadjuvant therapy (most commonly 6 months)
Quality of life, cancer-related fatigue, treatment tolerance and side-effects; physical activity behavior.
Questionnaire items (0 - 100 scale, with 0 being lower and 100 being the higher, positive outcome);
Measured: Baseline, and after the completion of neoadjuvant therapy (most likely 6 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled intervention (1:1 randomization). Specifically, 1 control group (usual care) and 1 intervention group (HIIT aerobic training), both receiving neoadjuvant therapy (immunochemotherapy) by infusion, as follows; Paclitaxel 80mg/m2 q1w x12, carboplatin 1.5 AUC q1w x12, pembrolizumab 200mg q3w x4, followed by epirubicin 90mg/ m2 q3w x 4, cyclophosphamide 600mg m2 q3w x 4, pembrolizumab 200mg q3w x 4. The intervention period (oncologic therapy + exercise intervention) is approximately 6 months (including screening phase and baseline data collection, tao), data collection after three months (ta1), after completion of neoadjuvant therapy (\~six months ta2), during which participants will complete the exercise intervention + oncologic treatment on site. Surgery will take place 2-3 weeks later.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- St. Elisabeth Krankenhaus Köln-Hohenlind
- Responsible party
- Principal investigator, Freerk Bauman, University Hospital of Cologne
- Investigators
- Freerk T Baumann, PhD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497322
- Sponsor's protocol ID
- No. 13-050
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patient-related data is collected in pseudonymized form. The procedure for pseudonymization will be as follows: The investigator will receive a patient identification form in his study folder. All study patients must be entered there with their full name, date of birth, study initials, and patient documentation sheet number. The patient identification list will be kept separate from the documentation records at the center. This list must be kept completely confidential and must not leave the study center. The patient identification list must be archived for 10 years after the end of the study and then destroyed. Data processing and data management is carried out by the University Hospital Cologne. It stores all changes to the data in an audit trail and has a study-specific customizable user and role concept. The database is integrated into a general IT infrastructure and security concept with firewall and backup system.
Publications
Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.
PubMed 32101663Cortes J, Rugo HS, Cescon DW, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Perez-Garcia J, Iwata H, Masuda N, Torregroza Otero M, Gokmen E, Loi S, Guo Z, Zhou X, Karantza V, Pan W, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2022 Jul 21;387(3):217-226. doi: 10.1056/NEJMoa2202809.
PubMed 35857659Sheinboim D, Parikh S, Manich P, Markus I, Dahan S, Parikh R, Stubbs E, Cohen G, Zemser-Werner V, Bell RE, Ruiz SA, Percik R, Brenner R, Leibou S, Vaknine H, Arad G, Gerber Y, Keinan-Boker L, Shimony T, Bikovski L, Goldstein N, Constantini K, Labes S, Mordechai S, Doron H, Lonescu A, Ziv T, Nizri E, Choshen G, Eldar-Finkelman H, Tabach Y, Helman A, Ben-Eliyahu S, Erez N, Perlson E, Geiger T, Ben-Zvi D, Khaled M, Gepner Y, Levy C. An Exercise-Induced Metabolic Shield in Distant Organs Blocks Cancer Progression and Metastatic Dissemination. Cancer Res. 2022 Nov 15;82(22):4164-4178. doi: 10.1158/0008-5472.CAN-22-0237.
PubMed 36084256Wolin KY, Yan Y, Colditz GA. Physical activity and risk of colon adenoma: a meta-analysis. Br J Cancer. 2011 Mar 1;104(5):882-5. doi: 10.1038/sj.bjc.6606045. Epub 2011 Feb 8.
PubMed 21304525Wu Y, Zhang D, Kang S. Physical activity and risk of breast cancer: a meta-analysis of prospective studies. Breast Cancer Res Treat. 2013 Feb;137(3):869-82. doi: 10.1007/s10549-012-2396-7. Epub 2012 Dec 30.
PubMed 23274845Sanft T, Harrigan M, McGowan C, Cartmel B, Zupa M, Li FY, Ferrucci LM, Puklin L, Cao A, Nguyen TH, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones BA, Knobf T, Chagpar AB, Silber A, Tanasijevic A, Ligibel JA, Irwin ML. Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study. J Clin Oncol. 2023 Dec 1;41(34):5285-5295. doi: 10.1200/JCO.23.00871. Epub 2023 Sep 1.
PubMed 37656930Lavin-Perez AM, Collado-Mateo D, Mayo X, Humphreys L, Liguori G, James Copeland R, Del Villar Alvarez F, Jimenez A. High-intensity exercise to improve cardiorespiratory fitness in cancer patients and survivors: A systematic review and meta-analysis. Scand J Med Sci Sports. 2021 Feb;31(2):265-294. doi: 10.1111/sms.13861. Epub 2020 Nov 5.
PubMed 33098219Gouez M, Perol O, Perol M, Caux C, Menetrier-Caux C, Villard M, Walzer T, Delrieu L, Saintigny P, Marijnen P, Pialoux V, Fervers B. Effect of acute aerobic exercise before immunotherapy and chemotherapy infusion in patients with metastatic non-small-cell lung cancer: protocol for the ERICA feasibility trial. BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819.
PubMed 35393316
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-intensity Interval Training During Neoadjuvant Immunochemotherapy on Complete Remission in Patients With Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06497322
- Acronym / sponsor ID
- No. 13-050
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Keywords
- Exercise, Immunotherapy, Oxygen uptake, CT scan, Blood markers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- St. Elisabeth Krankenhaus Köln-Hohenlind
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized, controlled, prospective, two-arm intervention study, the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative breast cancer. Breast cancer is one of the most common cancers and one of the leading causes of cancer-related deaths worldwide. Among the different subtypes, triple-negative breast cancer accounts for about 15-20% of all breast cancer cases and is characterized by a more aggressive clinical course. Recent results indicate that the percentage of patients with a pathologic complete response was 13% higher in the chemotherapy-immunotherapy group (by 64.8%) than in the placebo-chemotherapy group (51.2). High-intensity interval training has a positive effect on the immune system, suggesting that it may improve the efficacy of chemo-immunotherapy, leading to a higher rate of pathologic complete response (pCR) in patients with newly diagnosed triple-negative breast cancer. In addition to the immunomodulatory effects, this exercise model could boost microvascular perfusion, thereby improving tumor perfusion, enhancing chemo-immunotherapy and leading to better outcomes.
Detailed description
Recent clinical trials showed promising results in patients with triple negative breast cancer (TNBC) who received four cycles of pembrolizumab (at a dose of 200 mg) every three weeks + standard chemotherapy, compared to patients who received placebo + chemotherapy alone. Importantly, the overall risk of disease progression that precluded surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause was 37% lower with pembrolizumab chemotherapy compared to placebo chemotherapy. Exercise training is a supportive multi-effect strategy with the ability to influence multiple organ systems. There is growing epidemiologic evidence that a physically active lifestyle is associated with a lower risk of developing cancer, particularly colon and breast cancer. Recent preclinical studies suggest that exercise can control and attenuate the growth of tumor cells. Therefore, exercise could be a potential means to increase the rate of pCR in cancer patients in general. High-intensity interval training resulted in higher cardiorespiratory fitness levels, particularly in breast cancer and lung patients who exercised for at least 8 weeks, with a significant improvement (from 2.40 to 4.19 mL-min-1-kg-1) observed compared to control groups. The aim of this study is to investigate the effects of HIIT training on immune system response and pCR rates (most commonly defined as complete eradication of the tumor as a surrogate parameter for good prognosis) during neoadjuvant immunochemotherapy in women with TNBC. The working hypothesis is that HIIT training would activate the immune system and enhance the combination of neoadjuvant treatment, leading to higher rates of pCR in the aerobic group compared to the usual treatment group. Thus, this exercise model may also promote microvascular perfusion, improve tumor perfusion, and potentially lead to more favorable outcomes in neoadjuvant therapy, increasing the efficacy of systemic treatments and allowing for better therapeutic outcomes. The researchers support the idea that high-intensity aerobic exercise may at least partially challenge the large heterogeneity in response to medical treatment in women with a first diagnosis of TNBC and lead to higher response rates in the experimental group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled intervention (1:1 randomization). Specifically, 1 control group (usual care) and 1 intervention group (HIIT aerobic training), both receiving neoadjuvant therapy (immunochemotherapy) by infusion, as follows; Paclitaxel 80mg/m2 q1w x12, carboplatin 1.5 AUC q1w x12, pembrolizumab 200mg q3w x4, followed by epirubicin 90mg/ m2 q3w x 4, cyclophosphamide 600mg m2 q3w x 4, pembrolizumab 200mg q3w x 4. The intervention period (oncologic therapy + exercise intervention) is approximately 6 months (including screening phase and baseline data collection, tao), data collection after three months (ta1), after completion of neoadjuvant therapy (~six months ta2), during which participants will complete the exercise intervention + oncologic treatment on site. Surgery will take place 2-3 weeks later.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Exercise intervention - High intensity interval training on a cycle-ergometerAll women in the experimental group receive standardized high-intensity interval training over a period of 6 months in combination with neoadjuvant therapy (immunochemotherapy). The individual training sessions are guided and monitored by qualified exercise therapists, taking into account the side effects of ongoing treatment. Each training session will last about one hour, with the effective training time being 30 minutes. Bike training begins 1 hour before neoadjuvant therapy and then at the same time of day between therapies. The TNBC patients start with 5 minutes of cycling followed by 3 × 3 - minute HIIT training sequences, constantly alternating: i) 30 s at 90% of maximal PO (70 rpm for 30 s) and ii) 30 s of light pedaling at 20% of PO). The training session will be concluded with a 5-min cool-down cycling (easy pedaling) and stretching. This protocol will be performed twice a week throughout the study. |
| Control group | No intervention | –The control group will receive the standard care during their neoadjuvant therapy (immunochemotherapy) over a 6-month period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary diagnosis of histologically verified triple-negative breast cancer (TNBC) measurable by ultrasound imaging
- Stage of disease: T1c and nodal status N1-2 or Stage T2-4 and nodal status N0-2
- Deemed eligible for intended treatment with Paclitaxel 80mg/m2 q1w x12, Carboplatin 1,5 AUC q1w x12, Pembrolizumab 200mg q3w x4 followed by Epirubicin 90mg/ m2 q3w x 4, Cyclophosphamid 600mg m2 q3w x 4, Pembrolizumab 200mg q3w x 4; by the treating physician
- Treatment in curative intent with life expectancy ≥ 3 months
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.
Key exclusion criteria (9 listed)
- History of invasive malignancy ≤2 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Any history of previous systemic treatment for TNBC;
- Any diseases that do not allow sports activity, such as:
- Participation in another exercise study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise intervention - High intensity interval training on a cycle-ergometerThe experimental group starts with 5 minutes of unloaded cycling, followed by 3 × 3-minute HIIT training sequences alternating between: i) 30 seconds at 90% of maximal PO (70 rpm for 30 seconds) and ii) 30 seconds of light pedaling at 20% of PO). Recent work suggests that this high-intensity approach to aerobic exercise is feasible and safe, even during acute oncology treatment. The HIIT sequences are interspersed with two 3-minute cycling sessions at moderate intensity. The training session will be concluded with a 5-minute cool-down by cycling (light pedaling) and stretching. This protocol will be performed twice a week throughout the study, and all patients who reach an 80% adherence threshold for the exercise intervention will be included in the final analysis. | Other | Experimental group |
Primary outcome
Pathological complete remission of the tumor (pCR);
Time frame: After completion of neoadjuvant therapy and after surgery (6 months from study onset)
The absence of residual invasive cancer of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system)
6 secondary outcomes
Mamma- Ultrasound (the overall response rate of tumor mass);
Time frame: Baseline (prior to any data collection or therapy administration), and every three weeks during neoadjuvant chemotherapy
Progression free survival and Overall survival
Time frame: Epidemiological data collected during the study and three years afterwards
Cardiorespiratory fitness
Time frame: At baseline (prior to any data collection or therapy administration), three months after baseline, and six months after baseline (following completion of neoadjuvant therapy)
OCTA - optical coherence tomography angiography
Time frame: At baseline (prior to any data collection or therapy administration) and after the completion of neoadjuvant therapy (most commonly 6 months)
Biomarkers of immune response
Time frame: At baseline (prior to any data collection or therapy administration) and after the completion of neoadjuvant therapy (most commonly 6 months)
Quality of life, cancer-related fatigue, treatment tolerance and side-effects; physical activity behavior.
Time frame: Baseline, and after the completion of neoadjuvant therapy (most likely 6 months after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Results publication: PubMed 32101663Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.
- Results publication: PubMed 35857659Cortes J, Rugo HS, Cescon DW, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Perez-Garcia J, Iwata H, Masuda N, Torregroza Otero M, Gokmen E, Loi S, Guo Z, Zhou X, Karantza V, Pan W, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2022 Jul 21;387(3):217-226. doi: 10.1056/NEJMoa2202809.
- Results publication: PubMed 36084256Sheinboim D, Parikh S, Manich P, Markus I, Dahan S, Parikh R, Stubbs E, Cohen G, Zemser-Werner V, Bell RE, Ruiz SA, Percik R, Brenner R, Leibou S, Vaknine H, Arad G, Gerber Y, Keinan-Boker L, Shimony T, Bikovski L, Goldstein N, Constantini K, Labes S, Mordechai S, Doron H, Lonescu A, Ziv T, Nizri E, Choshen G, Eldar-Finkelman H, Tabach Y, Helman A, Ben-Eliyahu S, Erez N, Perlson E, Geiger T, Ben-Zvi D, Khaled M, Gepner Y, Levy C. An Exercise-Induced Metabolic Shield in Distant Organs Blocks Cancer Progression and Metastatic Dissemination. Cancer Res. 2022 Nov 15;82(22):4164-4178. doi: 10.1158/0008-5472.CAN-22-0237.
- Results publication: PubMed 21304525Wolin KY, Yan Y, Colditz GA. Physical activity and risk of colon adenoma: a meta-analysis. Br J Cancer. 2011 Mar 1;104(5):882-5. doi: 10.1038/sj.bjc.6606045. Epub 2011 Feb 8.
- Results publication: PubMed 23274845Wu Y, Zhang D, Kang S. Physical activity and risk of breast cancer: a meta-analysis of prospective studies. Breast Cancer Res Treat. 2013 Feb;137(3):869-82. doi: 10.1007/s10549-012-2396-7. Epub 2012 Dec 30.
- Results publication: PubMed 37656930Sanft T, Harrigan M, McGowan C, Cartmel B, Zupa M, Li FY, Ferrucci LM, Puklin L, Cao A, Nguyen TH, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones BA, Knobf T, Chagpar AB, Silber A, Tanasijevic A, Ligibel JA, Irwin ML. Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study. J Clin Oncol. 2023 Dec 1;41(34):5285-5295. doi: 10.1200/JCO.23.00871. Epub 2023 Sep 1.
- Results publication: PubMed 33098219Lavin-Perez AM, Collado-Mateo D, Mayo X, Humphreys L, Liguori G, James Copeland R, Del Villar Alvarez F, Jimenez A. High-intensity exercise to improve cardiorespiratory fitness in cancer patients and survivors: A systematic review and meta-analysis. Scand J Med Sci Sports. 2021 Feb;31(2):265-294. doi: 10.1111/sms.13861. Epub 2020 Nov 5.
- Results publication: PubMed 35393316Gouez M, Perol O, Perol M, Caux C, Menetrier-Caux C, Villard M, Walzer T, Delrieu L, Saintigny P, Marijnen P, Pialoux V, Fervers B. Effect of acute aerobic exercise before immunotherapy and chemotherapy infusion in patients with metastatic non-small-cell lung cancer: protocol for the ERICA feasibility trial. BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819.
- Individual participant dataSharing planned: Yes. All patient-related data is collected in pseudonymized form. The procedure for pseudonymization will be as follows: The investigator will receive a patient identification form in his study folder. All study patients must be entered there with their full name, date of birth, study initials, and patient documentation sheet number. The patient identification list will be kept separate from the documentation records at the center. This list must be kept completely confidential and must not leave the study center. The patient identification list must be archived for 10 years after the end of the study and then destroyed. Data processing and data management is carried out by the University Hospital Cologne. It stores all changes to the data in an audit trail and has a study-specific customizable user and role concept. The database is integrated into a general IT infrastructure and security concept with firewall and backup system.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damir Zubac, PhD contact
Freerk T Baumann, PhD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention - High intensity interval training on a cycle-ergometer in people with Breast Cancer and Triple Negative Breast Cancer, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Freerk T Baumann, PhD (0221-478-42649, freerk.baumann@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission of the tumor (pCR); (time frame: After completion of neoadjuvant therapy and after surgery (6 months from study onset)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06497322, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.