Status:
COMPLETED
An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.
Lead Sponsor:
Vejle Hospital
Collaborating Sponsors:
Region of Southern Denmark
Conditions:
Shoulder Pain
Late Effect
Eligibility:
FEMALE
18-78 years
Phase:
NA
Brief Summary
In breast cancer patients late-term upper limb sequelae, such as shoulder pain and impaired shoulder function remain common after primary breast cancer surgery. The aim of this trial is to evaluate wh...
Detailed Description
Worldwide, breast cancer is the second most common cancer. Internationally, an age-standardised incidence rate between 83.1 and 111.9 per 100.000 women is seen, with Denmark taking an unfortunate seco...
Eligibility Criteria
Inclusion
- Breast cancer patients who underwent unilateral BCS or mastectomy on the left or right side, including SLND or +/- ALND within the last 3-7 years (2015-2019)
- Currently living in the Region of Southern Denmark or Central Denmark Region with a radius of 75 km from Vejle Hospital
- Between 18 and 71 age on time of surgery for primary breast cancer
- Indicate pain in chest and/or shoulder area (shoulder impairments) as the biggest problem/late-term effect in everyday life
- Indicate impaired shoulder function due to pain or due to tightness/tension
- Indicate shoulder pain at rest, during general activities, during sleep or during flexion, rotation or abduction of the shoulder
- A score ≥15 on the Disabilities of the Arm, Shoulder and Hand (Quick DASH)
- Agree to participate in this trial and signs written informed consent
Exclusion
- No previous breast cancer (before 2014)
- Cancer relapse after the date of index surgery, cancer spread outside of thorax and axilla, tumor fixed to chest wall
- Primary- or secondary breast reconstruction performed at any time
- Severe lymphedema (an average score ≥ 70% in the first 7 questionnaires on the LYMPH-ICF-DK
- Bilateral breast cancer surgery
- Previous surgery in the affected shoulder (prior to inclusion)
- Previous shoulder or upper limb fractures (left/right)
- Currently receiving chemo, immuno- or radiotherapy
- Co-morbidity expected to influence shoulder function (e.g. rheumatoid arthritis, previous stroke, multiple sclerosis)
- Other reasons for exclusion (e.g. pregnancy, not legally competent, unable to comprehend the information or unable to consent)
Key Trial Info
Start Date :
April 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05277909
Start Date
April 4 2022
End Date
October 10 2022
Last Update
November 8 2022
Active Locations (1)
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1
Department of Physio- and Occupational Therapy, Vejle Hospital
Vejle, Denmark, 7100