Lifting Effect on Recovery After Mastectomy (MUSKELI)
Primary Purpose
Seroma Complicating A Procedure
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifting exercise
Standard exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Seroma Complicating A Procedure
Eligibility Criteria
Inclusion Criteria:
- patients with breast cancer diagnosis requiring mastectomy
- patients being operated in day-care regime
Exclusion Criteria:
- patients not eligible for day-care mastectomy
- patients undergoing axillary clearance operation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention group
Control Group
Arm Description
The patients undergoing intervention exercise.
The patients undergoing the normal exercise program
Outcomes
Primary Outcome Measures
Volume of seroma formation after mastectomy.
Secondary Outcome Measures
Number of wound problems requiring intervention.
Rate of lymphedema
Difference in upper limb volume after the surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05178329
Brief Title
Lifting Effect on Recovery After Mastectomy
Acronym
MUSKELI
Official Title
Lifting Effect on Recovery After Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anselm Tamminen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breast cancer surgery has evolved towards ever more breast conserving direction. Even thought the surgical regime has become easier for the patient, many instructions given to the patient after the operation base on instructions, which have been used when the performed operations have been more burdensome.
Previously the patients have been instructed to lift only light objects after the operation, but according to the current knowledge, this instruction might be unnecessary.
The meaning of this study is to compare two patient groups to each other. The other group is instructed to avoid lifting, and the other group is given instructions to lift light weights several times daily.
In the study we compare will this have an effect on
incidence of upper limb lymphedema
seroma formation after surgery
quality of patients life after the surgery
Inclusion criteria is patients underoing mastectomy but no axillary clearance on day-care basis. Patietns will be randomized in two groups, the other as an intervention group and other as an control group. The patients are asked to fill a questionnaire considering recovery from the operation and possible wound healing problems. The amount of seroma is recorded. The volume of upper limbs is measured before and after the surgery.
The study is started in January 2022 and finished in December 2024.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma Complicating A Procedure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
The patients undergoing intervention exercise.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The patients undergoing the normal exercise program
Intervention Type
Behavioral
Intervention Name(s)
Lifting exercise
Intervention Description
Patients are instructed for a light lifting exercise after mastectomy.
Intervention Type
Behavioral
Intervention Name(s)
Standard exercise
Intervention Description
Standard exercise program after mastectomy
Primary Outcome Measure Information:
Title
Volume of seroma formation after mastectomy.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of wound problems requiring intervention.
Time Frame
six months
Title
Rate of lymphedema
Description
Difference in upper limb volume after the surgery
Time Frame
one year
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with breast cancer diagnosis requiring mastectomy
patients being operated in day-care regime
Exclusion Criteria:
patients not eligible for day-care mastectomy
patients undergoing axillary clearance operation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anselm Tamminen, MD
Phone
+35823138626
Email
anselm.tamminen@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilkka Koskivuo, MD, PhD
Organizational Affiliation
TYKS
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Lifting Effect on Recovery After Mastectomy
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