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Status unknownNCT05178329MUSKELIUpdated Apr 28, 2022

Lifting Effect on Recovery After Mastectomy

An interventional study of Lifting exercise and Standard exercise in Seroma Complicating A Procedure, sponsored by Anselm Tamminen. Status unknown. Open to female participants. Per ClinicalTrials.gov, last updated 2022-04-28.

Sponsored by Anselm Tamminen · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
Female
01

Study 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

  1. incidence of upper limb lymphedema
  2. seroma formation after surgery
  3. 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.

02

Conditions studied

  • Seroma Complicating A Procedure

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03

In context

Seroma

101 studies on the registry are indexed under Seroma; 22 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 92 interventional studies indexed under Seroma.

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Lead sponsor

This is the only study on the registry with Anselm Tamminen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with breast cancer diagnosis requiring mastectomy
  • patients being operated in day-care regime

Exclusion criteria

Exclusion Criteria:

  • patients not eligible for day-care mastectomy
  • patients undergoing axillary clearance operation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Intervention group

    The patients undergoing intervention exercise.

    Behavioral: Lifting exercise

  • Placebo comparator
    Control Group

    The patients undergoing the normal exercise program

    Behavioral: Standard exercise

Interventions

  • BehavioralLifting exercise

    Patients are instructed for a light lifting exercise after mastectomy.

  • BehavioralStandard exercise

    Standard exercise program after mastectomy

06

What researchers measure

Primary outcomes

  1. Volume of seroma formation after mastectomy.

    Time frame: 30 days

Secondary outcomes

  1. Number of wound problems requiring intervention.

    Time frame: six months

  2. Rate of lymphedema

    Difference in upper limb volume after the surgery

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05178329
Lead sponsor
Anselm Tamminen
Responsible party
Anselm Tamminen (Consultant General Surgeon, Turku University Hospital) — Sponsor-investigator
First posted
Jan 5, 2022
Start date
Sep 2022 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
Apr 28, 2022

Study contacts

Anselm Tamminen, MD
Contact
anselm.tamminen@tyks.fi
+35823138626
Ilkka Koskivuo, MD, PhD
principal investigator · TYKS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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