Lifting Effect on Recovery After Mastectomy

NCT ID: NCT05178329

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-12-31

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

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.

Detailed Description

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Conditions

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Seroma Complicating A Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention group

The patients undergoing intervention exercise.

Group Type ACTIVE_COMPARATOR

Lifting exercise

Intervention Type BEHAVIORAL

Patients are instructed for a light lifting exercise after mastectomy.

Control Group

The patients undergoing the normal exercise program

Group Type PLACEBO_COMPARATOR

Standard exercise

Intervention Type BEHAVIORAL

Standard exercise program after mastectomy

Interventions

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Lifting exercise

Patients are instructed for a light lifting exercise after mastectomy.

Intervention Type BEHAVIORAL

Standard exercise

Standard exercise program after mastectomy

Intervention Type BEHAVIORAL

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Anselm Tamminen

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anselm Tamminen

Consultant General Surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ilkka Koskivuo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

TYKS

Central Contacts

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Anselm Tamminen, MD

Role: CONTACT

+35823138626

Other Identifiers

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93 /1801/2021

Identifier Type: -

Identifier Source: org_study_id

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