Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309290
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-02-29
Brief Title:
Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy
Sponsor:
Universidad de La Frontera
Organization:
Universidad de La Frontera
Study Overview
Official Title:
Prehabilitation Based on Resistance-exercise Training in Women With Breast Cancer Undergoing Neoadjuvant Therapy From Molecular Mechanism to Clinical Benefits
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
PRE-RET
Brief Summary:
Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide with the highest incidence of any cancer type The choice of therapeutic interventions hinges upon factors like cancer stage cell subtype and tumor size Consequently individuals with more aggressive tumors such as HER2 and Triple Negative or larger tumors often undergo neoadjuvant chemotherapy before breast surgery However these anticancer treatments come with side effects like cancer-related fatigue reduced functional capacity and changes in body composition notably skeletal muscle atrophy Skeletal muscle loss correlates with heightened mortality rates cardiotoxicity and diminished quality of life underscoring the need for early therapeutic interventions One such promising strategy is prehabilitation which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease even preceding breast surgery Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer however its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown
Detailed Description:
Hypothesis Prehabilitation based on resistance-exercise training before surgery in women with breast cancer undergoing neoadjuvant therapy increases skeletal muscle mass compared with usual care
Secondary prehabilitation based on resistance-exercise training before surgery in women with breast cancer undergoing neoadjuvant therapy generates better results in body composition physical performance clinical parameters serious adverse events hospital readmission infection complications physiological parameters and quality of life at one-month hospital discharge compared to usual care
Objective To determine the effects of prehabilitation based on resistance-exercise training versus usual care before and after breast surgery on skeletal muscle mass in women with breast cancer undergoing neoadjuvant chemotherapy
Methodology A single-blind randomized controlled clinical trial will be developed Sixty-eight postmenopausal women with stage I II and III breast cancer with HER2 type breast tumor and Triple negative breast cancer undergoing neoadjuvant therapy and with an indication for breast surgery will be divided into two groups usual care CONTROL n34 versus Prehabilitation P-REHAB n34 All participants will receive an education session 20 weeks before surgery neoadjuvant chemotherapy for 16-20 weeks as is normally done for this type of patien Only participants in the P-REHAB group will undergo 16-20 weeks of whole-body resistance-exercise training twice a week At baseline after prehabilitation program and 4 weeks after surgery the cross-sectional area of the quadriceps muscle and of the muscle region at lumbar level 3 will be determined by CT-Scan Also fasting blood samples will be obtained to measure biochemical and molecular markers eg miRNAs Maximal strength will be determined by 1 repetition maximum 1RM leg press leg extension lat pull down chest press horizontal row and handgrip In addition physical performance will be assessed with the short physical performance battery SPPB functional capacity with the 6-minute walk test quality of life with the BR23 questionnaire and cancer-related fatigue with the Brief Fatigue Inventory scale at the same time points Finally samples from tumor breast cancer and pectoralis muscle will be obtained on the day of breast surgery
Expected results It is expected that prehabilitation based on resistance-exercise training results in increased muscle mass in women with breast cancer undergoing neoadjuvant chemotherapy compared to participants receiving usual care Also it is expected that this intervention before surgery in women with breast cancer undergoing neoadjuvant therapy will generate better results in clinical parameters serious adverse events hospital readmission infection complications and quality of life one month after hospital discharge compared to usual care These results will allow the creation of local regional national and international strategies to combat the adverse effects of breast cancer and its antineoplastic treatment especially in women with more aggressive breast cancer
Secondary prehabilitation based on resistance-exercise training before surgery in women with breast cancer undergoing neoadjuvant therapy generates better results in body composition physical performance clinical parameters serious adverse events hospital readmission infection complications physiological parameters and quality of life at one-month hospital discharge compared to usual care
Objective To determine the effects of prehabilitation based on resistance-exercise training versus usual care before and after breast surgery on skeletal muscle mass in women with breast cancer undergoing neoadjuvant chemotherapy
Methodology A single-blind randomized controlled clinical trial will be developed Sixty-eight postmenopausal women with stage I II and III breast cancer with HER2 type breast tumor and Triple negative breast cancer undergoing neoadjuvant therapy and with an indication for breast surgery will be divided into two groups usual care CONTROL n34 versus Prehabilitation P-REHAB n34 All participants will receive an education session 20 weeks before surgery neoadjuvant chemotherapy for 16-20 weeks as is normally done for this type of patien Only participants in the P-REHAB group will undergo 16-20 weeks of whole-body resistance-exercise training twice a week At baseline after prehabilitation program and 4 weeks after surgery the cross-sectional area of the quadriceps muscle and of the muscle region at lumbar level 3 will be determined by CT-Scan Also fasting blood samples will be obtained to measure biochemical and molecular markers eg miRNAs Maximal strength will be determined by 1 repetition maximum 1RM leg press leg extension lat pull down chest press horizontal row and handgrip In addition physical performance will be assessed with the short physical performance battery SPPB functional capacity with the 6-minute walk test quality of life with the BR23 questionnaire and cancer-related fatigue with the Brief Fatigue Inventory scale at the same time points Finally samples from tumor breast cancer and pectoralis muscle will be obtained on the day of breast surgery
Expected results It is expected that prehabilitation based on resistance-exercise training results in increased muscle mass in women with breast cancer undergoing neoadjuvant chemotherapy compared to participants receiving usual care Also it is expected that this intervention before surgery in women with breast cancer undergoing neoadjuvant therapy will generate better results in clinical parameters serious adverse events hospital readmission infection complications and quality of life one month after hospital discharge compared to usual care These results will allow the creation of local regional national and international strategies to combat the adverse effects of breast cancer and its antineoplastic treatment especially in women with more aggressive breast cancer
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