Lifting Effect on Recovery After Mastectomy

Study Overview
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Brief Summary
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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.

Official Title
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Lifting Effect on Recovery After Mastectomy

Conditions
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Seroma Complicating A Procedure

Intervention / Treatment
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* Behavioral: Lifting exercise
* Behavioral: Standard exercise


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>The patients undergoing intervention exercise. | Behavioral: Lifting exercise<br>* Patients are instructed for a light lifting exercise after mastectomy.<br>|
| Placebo Comparator: Control Group<br>The patients undergoing the normal exercise program | Behavioral: Standard exercise<br>* Standard exercise program after mastectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of seroma formation after mastectomy. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of wound problems requiring intervention. |  | six months | 
| Rate of lymphedema | Difference in upper limb volume after the surgery | one year |