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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
Anselm Tamminen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Seroma Complicating A Procedure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    December 2, 2021
    Last Updated
    April 27, 2022
    Sponsor
    Anselm Tamminen
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    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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