Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297265
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-02-09
Brief Title:
Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Feasibility and Effects of Manual Lymphatic Drainage MLD Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body localized Breast conserving surgery can be an effective treatment option for early stage breast cancer but it can also be associated with side effects including fluid collection in tissuesswelling lymphedema pain reduced quality of life and poorer body image Manual lymphatic drainage is a gentle massage technique used to reduce swelling It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I Evaluate the feasibility of breast manual lymphatic drainage MLD on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery
SECONDARY OBJECTIVES
I Evaluate the tolerability of breast manual lymphatic drainage MLD on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery
II Preliminarily assess the effect on acute and chronic breast edema pain functional status quality of life body image and radiation induced fibrosis RIF
OUTLINE
Patients undergo MLD breast massage over 30-60 minutes twice a week BIW for the duration of standard of care SOC radiation therapy and for 1 month thereafter
After completion of SOC radiation therapy patients are followed up at 2-4 weeks and 3 6 and 12 months
I Evaluate the feasibility of breast manual lymphatic drainage MLD on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery
SECONDARY OBJECTIVES
I Evaluate the tolerability of breast manual lymphatic drainage MLD on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery
II Preliminarily assess the effect on acute and chronic breast edema pain functional status quality of life body image and radiation induced fibrosis RIF
OUTLINE
Patients undergo MLD breast massage over 30-60 minutes twice a week BIW for the duration of standard of care SOC radiation therapy and for 1 month thereafter
After completion of SOC radiation therapy patients are followed up at 2-4 weeks and 3 6 and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA014089 | NIH | USC Norris Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA014089 |
| NCI-2023-10828 | REGISTRY | None | None |
| 1B-23-2 | OTHER | None | None |