Seroma Complicating A ProcedureMUSKELINCT05178329
Lifting Effect on Recovery After Mastectomy
A study testing Lifting exercise and Standard exercise in people with Seroma Complicating A Procedure, run by Anselm Tamminen.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Seroma Complicating A Procedure
- What is being tested?
- Lifting exercise and Standard exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with breast cancer diagnosis requiring mastectomy
- patients being operated in day-care regime
Who cannot join
- patients not eligible for day-care mastectomy
- patients undergoing axillary clearance operation
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
- Conditions
- Seroma Complicating A Procedure
- Being tested
- Lifting exercise, Standard exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifting exerciseBehavioural
Patients are instructed for a light lifting exercise after mastectomy.
Standard exerciseBehavioural
Standard exercise program after mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The patients undergoing intervention exercise. Receives: Behavioral: Lifting exercise |
| Control Group | Placebo comparator | The patients undergoing the normal exercise program Receives: Behavioral: Standard exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of seroma formation after mastectomy.
Measured: 30 days
Secondary outcomes (2)
Number of wound problems requiring intervention.
Measured: six months
Rate of lymphedema
Difference in upper limb volume after the surgery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seroma Complicating A ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anselm Tamminen
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Anselm Tamminen, Turku University Hospital
- Investigators
- Ilkka Koskivuo, MD, PhD, Principal investigator, TYKS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178329
- Sponsor's protocol ID
- 93 /1801/2021
- Acronym
- MUSKELI
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifting Effect on Recovery After Mastectomy
- ClinicalTrials.gov ID
- NCT05178329
- Acronym / sponsor ID
- MUSKELI / 93 /1801/2021
- Conditions
- Seroma Complicating A Procedure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Anselm TamminenOther government
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Lifting exerciseThe patients undergoing intervention exercise. |
| Control Group | Placebo comparator | Behavioral: Standard exerciseThe patients undergoing the normal exercise program |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with breast cancer diagnosis requiring mastectomy
- patients being operated in day-care regime
Key exclusion criteria (2 listed)
- patients not eligible for day-care mastectomy
- patients undergoing axillary clearance operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifting exercisePatients are instructed for a light lifting exercise after mastectomy. | Behavioural | Intervention group |
| Standard exerciseStandard exercise program after mastectomy | Behavioural | Control Group |
Primary outcome
Volume of seroma formation after mastectomy.
Time frame: 30 days
2 secondary outcomes
Number of wound problems requiring intervention.
Time frame: six months
Rate of lymphedema
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Seroma Complicating A Procedure
Recruiting
Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
Parotid Neoplasms, Post-operative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilkka Koskivuo, MD, PhD principal investigator
TYKS
Questions about this trial
What is this clinical trial studying?
A study testing Lifting exercise and Standard exercise in people with Seroma Complicating A Procedure, run by Anselm Tamminen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anselm Tamminen, MD (+35823138626, anselm.tamminen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of seroma formation after mastectomy. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.