Lifting Effect on Recovery After Mastectomy (MUSKELI)

Anselm Tamminen

Status: Not yet enrolling

Conditions: Seroma Complicating A Procedure

Treatments: Behavioral: Standard exercise; Behavioral: Lifting exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05178329

93 /1801/2021

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

The patients undergoing intervention exercise.

Treatment:

Behavioral: Lifting exercise

Control Group

Placebo Comparator group

Description:

The patients undergoing the normal exercise program

Treatment:

Behavioral: Standard exercise