Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421285
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-10
Brief Title:
Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients
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:
None
Brief Summary:
Research purpose Lymphedema is a very common complication in breast cancer patients However since there is currently no curable treatment it is important to prevent and reduce the severity of lymphedema The purpose of this study is to evaluate whether preoperative exercise is effective in preventing lymphedema after surgery For secondary outcome the preventive effects of exercise on other upper extremity dysfunctions eg pectoralis tightness Axillary web syndrome Adhesive capsulitis which are common in breast cancer patients were assessed
Detailed Description:
Study subjects
Patients aged 20 or older who were first diagnosed with breast cancer
BMI over 23
Patients scheduled to undergo neoadjuvant chemotherapy before surgery Study design Prospective randomized controlled comparative clinical study
Intervention is performed for at least 3 months during the neoadjuvant chemotherapy period before surgery
Treatment group Individually tailored exercise consisting of aerobic strength and flexibility exercises is prescribed self-exercise compliance monitoring through an application and diet management education through nutritional counseling
Control group One session of flexibility exercise training diet management education through nutritional counseling
Result variable
Primary outcome variable
1 Incidence and severity of postoperative lymphedema bilateral upper limb volume ICG lymphography
Secondary outcome variables
1 Clinical information Demographic disease and treatment-related data
2 Physical-related heightweightwaist circumference measurement body composition test physical examination axillary membrane evaluation
3 Upper extremity function shortening of the pectoralis major muscle adhesive capsulitis evaluation of shoulder range of motion upper extremity muscle strengthgrip strength
4 Quality of life assessment European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast cancer module 23EORTC QLQ-BR23
Assessment Schedule
Initial treatment and evaluation Immediately after breast cancer diagnosis
Follow-up evaluation Immediately after completion of exercise intervention preoperatively and at 1 3 and 6 months postoperatively
Number of study subjects
This study will be conducted as a preliminary study for future research and will be conducted on a total of 60 patients 30 in the experimental group and 30 in the control group with an allocation ratio between groups of 11
Patients aged 20 or older who were first diagnosed with breast cancer
BMI over 23
Patients scheduled to undergo neoadjuvant chemotherapy before surgery Study design Prospective randomized controlled comparative clinical study
Intervention is performed for at least 3 months during the neoadjuvant chemotherapy period before surgery
Treatment group Individually tailored exercise consisting of aerobic strength and flexibility exercises is prescribed self-exercise compliance monitoring through an application and diet management education through nutritional counseling
Control group One session of flexibility exercise training diet management education through nutritional counseling
Result variable
Primary outcome variable
1 Incidence and severity of postoperative lymphedema bilateral upper limb volume ICG lymphography
Secondary outcome variables
1 Clinical information Demographic disease and treatment-related data
2 Physical-related heightweightwaist circumference measurement body composition test physical examination axillary membrane evaluation
3 Upper extremity function shortening of the pectoralis major muscle adhesive capsulitis evaluation of shoulder range of motion upper extremity muscle strengthgrip strength
4 Quality of life assessment European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast cancer module 23EORTC QLQ-BR23
Assessment Schedule
Initial treatment and evaluation Immediately after breast cancer diagnosis
Follow-up evaluation Immediately after completion of exercise intervention preoperatively and at 1 3 and 6 months postoperatively
Number of study subjects
This study will be conducted as a preliminary study for future research and will be conducted on a total of 60 patients 30 in the experimental group and 30 in the control group with an allocation ratio between groups of 11
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