Identifying factors affecting upper limb function after breast cancer treatment
Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
NA · KU Leuven · NCT05371847
This study looks at what might be causing ongoing arm problems in breast cancer survivors after treatment to help improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven (other) |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05371847 on ClinicalTrials.gov |
What this trial studies
This study aims to identify prognostic variables that contribute to persistent upper limb dysfunctions in breast cancer survivors following treatment. It focuses on assessing upper limb function in patients who have undergone surgery and adjuvant radiotherapy for breast cancer. By understanding these factors, the study seeks to improve the quality of life for breast cancer survivors by addressing barriers to physical activity caused by upper limb dysfunction. The methodology includes assessments and retests to evaluate upper limb function over time.
Who should consider this trial
Good fit: Ideal candidates include breast cancer patients scheduled for surgery and those receiving adjuvant radiotherapy.
Not a fit: Patients with widespread metastases or those who have undergone previous breast surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved interventions that enhance upper limb function and overall quality of life for breast cancer survivors.
How similar studies have performed: Other studies have shown success in identifying factors affecting quality of life in breast cancer survivors, suggesting that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for breast cancer patients * Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer. * Patients who receive adjuvant radiotherapy . * Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant * Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent Inclusion criteria healthy volunteers * Healthy women and men(quickDASH\<15) age- and gender-matched with a breast cancer patient from the main study * Volunteers who can comply with the protocol at baseline assessment and willing to provide written informed consent Exclusion Criteria breast cancer patients * BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery * And/or with a diagnosis of a neurological or rheumatological condition, diabetes, * And/or BCS who are not available the entire duration of the study Exclusion Criteria healthy volunteers * History of breast cancer * Patients with a diagnosis of neurological or rheumatological condition, diabetes
Where this trial is running
Leuven
- Universitair Ziekenhuis Leuven — Leuven, Belgium (RECRUITING)
Study contacts
- Principal investigator: An De Groef, Prof. Dr. — KU Leuven
- Study coordinator: An De Groef, Prof. Dr.
- Email: an.degroef@kuleuven.be
- Phone: 003216376668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, upper limb dysfunction