Lifting Effect on Recovery After Mastectomy

NCT05178329 | Unknown

• 1 other identifier: 93 /1801/2021
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

1. 1.incidence of upper limb lymphedema
2. 2.seroma formation after surgery
3. 3.quality of patients life after the surgery

Conditions

Seroma Complicating A Procedure

Outcome Measures

Primary Outcomes (1)

• Volume of seroma formation after mastectomy.

  30 days

Secondary Outcomes (2)

• Number of wound problems requiring intervention.

  six months

• Rate of lymphedema

  one year

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The patients undergoing intervention exercise.

Behavioral: Lifting exercise

Control Group

PLACEBO COMPARATOR

The patients undergoing the normal exercise program

Behavioral: Standard exercise

Interventions

Lifting exercise BEHAVIORAL

Patients are instructed for a light lifting exercise after mastectomy.

Intervention group

Standard exercise BEHAVIORAL

Standard exercise program after mastectomy

Control Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anselm Tamminen: lead

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ilkka Koskivuo, MD, PhD

  TYKS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anselm Tamminen, MD

CONTACT

+35823138626; anselm.tamminen@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant General Surgeon

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 5, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: April 28, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share