Clinical trial · Observational
The Impact of Lymphedema on Breast Cancer Survivors
The Impact of Lymphedema on Local and Overall Functioning
NCT00769821CI-TRIAL-00008664completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Gathering information from breast cancer survivors about lymphedema; its symptoms and their impact on shoulder, arm, and hand functioning; and quality of life may help doctors learn more about the disease. PURPOSE: This clinical trial is studying the impact of lymphedema on breast cancer survivors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Survivor | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| bioimpedance spectroscopy | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Degree of lymphedema as assessed by the Norman Questionnaire, Jane M. Armer's Lymphedema and Breast Cancer Questionnaire, arm circumference, and bioimpedance spectroscopy (BIS)
- timeFrame
- study visit approximately 5 hours
- measure
- Lymphedema-associated symptoms by Symptoms in the Affected Breast/Mastectomy site questionnaire; Symptoms in the Shoulder, Arm, or Hand on the Affected Side questionnaire; and General Symptom Experience questionnaire
- timeFrame
- study visit approximately 5 hours
- measure
- Local upper extremity function by tests & questionnaires (e.g., hand dominance; strength; range of motion & neurodynamics; fine motor control/finger coordination; skin exam; skin & scar sensation [Semmes-Weinstein Monofilament])
- timeFrame
- study visit approximately 5 hours
- measure
- Overall health-related functioning as assessed by Medical Outcomes Study-Short Form 36 (MOS-SF36), graded exercise test using a treadmill stress test, and cardio-respiratory fitness using peak VO2
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * No breast cancer on both sides * No recurrence of breast cancer (local or distant) * Completed active treatment for breast cancer (i.e., surgery and/or radiotherapy and/or chemotherapy) for ≥ 6 months * No prior contralateral or bilateral mastectomy * No pre-existing lymphedema prior to breast cancer diagnosis * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Weight \< 300 pounds * Mentally and physically able to participate * No current infection or lymphangitis involving the affected arm * No pre-existing neuromuscular conditions that would affect local upper extremity or overall health-related functioning * No contraindications to bioimpedance spectroscopy (BIS) testing, including the application of electrode adhesive pads to the skin (i.e., unable to lie supine, allergy to electrode adhesive pads, have sunburn, or have open wound) * No contraindications to exercise testing as outlined by the American Heart Association and the American College of Sports Medicine PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.