Arm Lymphedema After Breast Cancer Clinical Trial
— LYMPHATICOfficial title:
Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.
Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.
| Status | Not yet recruiting |
| Enrollment | 44 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Women between 45 and 65 years with secondary lymphedema in upper limb after breast cancer surgery. - Cancer stages I-III according to TNM classification of the American Joint Committee on Cancer. Exclusion Criteria: - To have received lymphedema treatment previously. - To be treated by radiation therapy or chemotherapy. - Distant metastases or local recurrence of cancer. - Infectious signs in the upper limb with lymphedema. - Uncontrolled hypertension. - Heart disease. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | University of Málaga | Málaga |
| Lead Sponsor | Collaborator |
|---|---|
| University of Malaga |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Perimetry | Arm volume is measured with perimetry through truncation of cones formula | Baseline, 6 weeks and 12 weeks | No |
| Secondary | Handgrip strength | Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR" | Baseline, 6 weeks and 12 weeks | No |
| Secondary | Multiple sit-to-stant test | Multiple sit-to-stant test will be used to evaluate lower limbs strength. | Baseline, 6 weeks and 12 weeks | No |
| Secondary | Degree of pain | The degree of pain in the affected side with lymphedema will be measured by digital algometer "Commander ™" | Baseline, 6 weeks and 12 weeks | No |
| Secondary | Pulmonary function test | Simple spirometry to measure lung function with a spirometer "DATOSPIR120" | Baseline, 6 weeks and 12 weeks | No |
| Secondary | Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) | The strength of the respiratory muscles is measured through a digital manovacuometer (DATOSPIR120) | Baseline, 6 weeks and 12 weeks | No |
| Secondary | Six-minute walking test | Cardiorespiratory functional capacity as measured with six-minute walking test. | Baseline, 6 weeks and 12 weeks | No |
| Secondary | FACT-B+4 questionnaire | FACT-B+4 questionnaire to measure quality of life in patients with breast cancer and lymphedema. Alpha of cronbach: 0,52-0,92 | Baseline, 6 weeks and 12 weeks | No |
| Secondary | EORTIC-QLQ-C30 questionnaire | EORTIC-QLQ-C30 questionnaire measures the quality of life in cancer. Alpha of cronbach: 0,52 y 0,89 | Baseline, 6 weeks and 12 weeks | No |
| Secondary | QLQ BR23 questionnaire | QLQ BR23 questionnaire to know quality of life in patients with breast cancer. Alpha of cronbach: 0,48 y 0,94 | Baseline, 6 weeks and 12 weeks | No |
| Secondary | HADS questionnaire | HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76 | Baseline, 6 weeks and 12 weeks | No |
| Secondary | QuickPIPPER questionnaire | QuickPIPPER questionnaire measures the level of fatigue in breast cancer. Alpha of cronbach: 0,730- 0,961 | Baseline, 6 weeks and 12 weeks | No |
| Secondary | The short version of the IPAQ | The short version of the IPAQ questionnaire for physical activity level. Alpha of cronbach: 0,75 | Baseline, 6 weeks and 12 weeks | No |
| Secondary | Qualitative measures | Data collection was carried out through an interview in-depth semi-structured. The dimensions of the study were developed based on bibliography and objectives of the study: perceptions and experiences with multimodal treatment, ways of living with lymphedema, life style, Physical activity and exercise. | 6 weeks | No |
| Secondary | Smartphone-based application | Smartphone-based application to analyze the treatment adherence of the participants | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks | No |