Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05297773
Status:
RECRUITING
Last Update Posted:
2023-02-09
First Post:
2022-01-25
Brief Title:
Resistance vs Aerobic Training on Breast Cancer Patients Undergoing Neoadjuvant Treatment
Sponsor:
Fundacao Champalimaud
Organization:
Fundacao Champalimaud
Study Overview
Official Title:
Effects of Resistance vs Aerobic Training on Ki-67 and Other Health-Related Biomarkers The NEO-Program a Randomized Controlled Trial on Breast Cancer Patients Undergoing Neoadjuvant Treatment
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEO-Program
Brief Summary:
A recent consensus study suggested that understanding the impact of exercise on the tumor microenvironment and therapy effectiveness is paramount and should be considered as a research priority Therefore the research team intends to address some of the scientific challenges proposed which represent clear gaps in the current knowledge
The investigators propose a randomized controlled trial conducted during all neoadjuvant treatment duration that aims to evaluate and compare the effects of two different exercise protocols aerobic and resistance training against a relaxation control group on Ki-67 changes as the main outcome in breast cancer patients Secondary outcomes will be body composition resting metabolic rate physical fitness quality of life fatigue depressionanxiety accelerometry data physical activity levels sedentary time sleep quality tumor biology size hypoxia and immune profile glycemic lipid and inflammatory profile
This project will help not only researchers with the design of future exercise intervention protocols but will also help exercise physiologists in the decision-making process when defining training programs Moreover the investigators expect that this research program will encourage more cancer patients to exercise The team expects that patients with breast cancer engaging in structured exercise will show a more marked decrease in Ki-67 tumor size and hypoxia and increase the tumor-infiltrating lymphocytes TILs compared to controls The investigators anticipate a more noticeable decrease in the preoperative endocrine prognostic index PEPI score and in the Residual Breast Cancer RCB in both training groups respectively with hormonal and chemotherapy Also frequent declines in physical fitness are expected to be mitigated in exercisers It is hypothesize that aerobic training will ameliorate cardiorespiratory fitness and fat mass while the effects of resistance training will be more relevant for muscle strength muscle mass and bone health Both exercise groups will show greater improvements in quality of life fatigue depression anxiety and sleep quality Regarding glycemic lipid and inflammatory profiles the investigators expect to see more favorable changes in both training groups with a more evident decrease in fasting glucose and insulin HbA1c total and LDL-cholesterol and triglycerides and the increase in HDL-cholesterol The increase in C-reactive protein CRP tumor necrosis factor -α TNF-α interleukin-6 IL-6 IL-8 IL-1β IL-1ra and insulin-like growth factor-1 IGF-1 and the decrease in brain-derived neutrotophic factor BDNF IL-12p70 IL-10 oncostatin M will be smaller in exercise groups
The investigators propose a randomized controlled trial conducted during all neoadjuvant treatment duration that aims to evaluate and compare the effects of two different exercise protocols aerobic and resistance training against a relaxation control group on Ki-67 changes as the main outcome in breast cancer patients Secondary outcomes will be body composition resting metabolic rate physical fitness quality of life fatigue depressionanxiety accelerometry data physical activity levels sedentary time sleep quality tumor biology size hypoxia and immune profile glycemic lipid and inflammatory profile
This project will help not only researchers with the design of future exercise intervention protocols but will also help exercise physiologists in the decision-making process when defining training programs Moreover the investigators expect that this research program will encourage more cancer patients to exercise The team expects that patients with breast cancer engaging in structured exercise will show a more marked decrease in Ki-67 tumor size and hypoxia and increase the tumor-infiltrating lymphocytes TILs compared to controls The investigators anticipate a more noticeable decrease in the preoperative endocrine prognostic index PEPI score and in the Residual Breast Cancer RCB in both training groups respectively with hormonal and chemotherapy Also frequent declines in physical fitness are expected to be mitigated in exercisers It is hypothesize that aerobic training will ameliorate cardiorespiratory fitness and fat mass while the effects of resistance training will be more relevant for muscle strength muscle mass and bone health Both exercise groups will show greater improvements in quality of life fatigue depression anxiety and sleep quality Regarding glycemic lipid and inflammatory profiles the investigators expect to see more favorable changes in both training groups with a more evident decrease in fasting glucose and insulin HbA1c total and LDL-cholesterol and triglycerides and the increase in HDL-cholesterol The increase in C-reactive protein CRP tumor necrosis factor -α TNF-α interleukin-6 IL-6 IL-8 IL-1β IL-1ra and insulin-like growth factor-1 IGF-1 and the decrease in brain-derived neutrotophic factor BDNF IL-12p70 IL-10 oncostatin M will be smaller in exercise groups
Detailed Description:
Exercise plays a crucial role in breast cancer prevention and more recently it appears as a safe non-pharmacological and cost-effective adjuvant therapy for cancer Indeed exercise improves the quality of life fatigue physical fitness and also has a positive impact on tumor intrinsic characteristics
Most of the studies regarding the effects of exercise in breast cancer patients were performed after surgery or in survivors Despite being a window of opportunity to study the impact of exercise on biological properties of the tumor namely on proliferation markers the investigations conducted during the neoadjuvant period are still scarce and most of the literature derives from animal studies Although originating from pilot investigations the initial human-based evidence suggests that exercise interventions are feasible during neoadjuvant therapy and can potentially reduce some proliferation markers such as Ki-67 ie a widely used prognostic marker induce favorable changes in tumor-related genes and increase survival
Power and sample calculations G-Power Version 3192 are based on an effect size of 025 for KI-67 while using ANOVA - repeated measures within-between interactions a power of 080 a significance of 005 and an expected dropout of 40 The calculation yielded a total sample size of 120 participants 60 undergoing chemotherapy and 60 undergoing hormone therapy 20 participants per group per each treatment The power and sample calculations were performed using a study that reported the effect of medication on KI-67 since no study has evaluated the effects of an exercise intervention on that variable and has obtained significant results
Participants will be recruited to take part in an intervention study for breast cancer patients undergoing neoadjuvant treatment The recruitment will take place at Champalimaud Clinical Center Breast Unit Champalimaud Foundation
To improve exercise adherence the following strategies will be implemented
Thematic sessions about several topics such as physical activity PA guidelines active lifestyle nutrition the benefits of exercise for breast cancer patients etc Each session will last 1-hour 30 minutes presentation 30 minutes discussionquestions and will occur once a month These thematic sessions are mandatory
Group activities once a month a group activity will be promoted exercise outdoor sessions group walk group dinner etc In these group activities participants may invite family members to participate
The NEO-program website presenting the missiongoals team members activities news and events contacts etc
Facebook and Instagram account share information and photos before the intervention written consent for image collection will be requested
The investigator records clinical data using a paper or electronic case report form CRF all data is collected in an online database that is available through the Champalimaud Clinical Center intranet Participating physicians have a personal account to log in to the registration page and access the electronic CRF They will have permanent access to their series of patients
The participating physician ensures the confidentiality accuracy completeness legibility and timeliness of the data recorded Data handling and statistical analysis will be done anonymously by the investigator with the subject identification code list only available to the local investigator and research nurse if applicable working in the local center The code will be based on the birth date and center abbreviation and not patient initials The Sponsor will be the owner of the data Data will be kept for 20 years
The Participating Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site andor Investigator in this study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study
The collection processing and disclosure of personal data such as patient health and medical information are subject to compliance with applicable personal data protection and the processing of personal data legislation including but not limited to the European Union Directive 9546EC
Champalimaud Foundation takes out the appropriate insurance
Most of the studies regarding the effects of exercise in breast cancer patients were performed after surgery or in survivors Despite being a window of opportunity to study the impact of exercise on biological properties of the tumor namely on proliferation markers the investigations conducted during the neoadjuvant period are still scarce and most of the literature derives from animal studies Although originating from pilot investigations the initial human-based evidence suggests that exercise interventions are feasible during neoadjuvant therapy and can potentially reduce some proliferation markers such as Ki-67 ie a widely used prognostic marker induce favorable changes in tumor-related genes and increase survival
Power and sample calculations G-Power Version 3192 are based on an effect size of 025 for KI-67 while using ANOVA - repeated measures within-between interactions a power of 080 a significance of 005 and an expected dropout of 40 The calculation yielded a total sample size of 120 participants 60 undergoing chemotherapy and 60 undergoing hormone therapy 20 participants per group per each treatment The power and sample calculations were performed using a study that reported the effect of medication on KI-67 since no study has evaluated the effects of an exercise intervention on that variable and has obtained significant results
Participants will be recruited to take part in an intervention study for breast cancer patients undergoing neoadjuvant treatment The recruitment will take place at Champalimaud Clinical Center Breast Unit Champalimaud Foundation
To improve exercise adherence the following strategies will be implemented
Thematic sessions about several topics such as physical activity PA guidelines active lifestyle nutrition the benefits of exercise for breast cancer patients etc Each session will last 1-hour 30 minutes presentation 30 minutes discussionquestions and will occur once a month These thematic sessions are mandatory
Group activities once a month a group activity will be promoted exercise outdoor sessions group walk group dinner etc In these group activities participants may invite family members to participate
The NEO-program website presenting the missiongoals team members activities news and events contacts etc
Facebook and Instagram account share information and photos before the intervention written consent for image collection will be requested
The investigator records clinical data using a paper or electronic case report form CRF all data is collected in an online database that is available through the Champalimaud Clinical Center intranet Participating physicians have a personal account to log in to the registration page and access the electronic CRF They will have permanent access to their series of patients
The participating physician ensures the confidentiality accuracy completeness legibility and timeliness of the data recorded Data handling and statistical analysis will be done anonymously by the investigator with the subject identification code list only available to the local investigator and research nurse if applicable working in the local center The code will be based on the birth date and center abbreviation and not patient initials The Sponsor will be the owner of the data Data will be kept for 20 years
The Participating Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site andor Investigator in this study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study
The collection processing and disclosure of personal data such as patient health and medical information are subject to compliance with applicable personal data protection and the processing of personal data legislation including but not limited to the European Union Directive 9546EC
Champalimaud Foundation takes out the appropriate insurance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NEO-Program | OTHER | Fundação Champalimaud | None |