Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569719
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Effectiveness of CDT for the Treatment of Lymphedema in Breast Cancer Patients Who Received LVA Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Complex Decongestive Therapy for the Treatment of Lymphedema in Breast Cancer Patients Who Received Lymphovenous Anastomosis Surgery A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer is the most common type of cancer in women worldwide Advances in treatment have increased survival rates so patients must live with the complications resulting from the cancer and its treatment One of the most common side effects is lymphedema which can occur as a secondary effect of surgical or radiotherapy treatment Lymphatic edema is a condition characterized by an excess of lymphatic fluid rich in proteins in the subcutaneous tissue causing pain a feeling of heaviness in the affected limb restricted range of motion and in some cases progressing to the formation of ulcers and recurrent infections inevitably affecting the quality of life of the women who suffer from it There are various therapeutic strategies to reduce the risk of developing lymphedema or to treat it Among the management options is complex decongestive therapy CDT which is a conservative treatment that includes manual lymphatic drainage MLD compression therapy skin care and lymph-reducing exercises LRE Surgical options include lymph node transfer and lymphovenous anastomosis redirecting lymphatic circulation and reducing edema in the affected limb This is why the current research is undertaken aiming to evaluate the effectiveness of combining these two treatment approaches in terms of reducing lymphedema the presence of cellulitis and changes in patients quality of life
Detailed Description:
Breast cancer is the most common type of cancer among women with an estimated 23 million new cases diagnosed worldwide in 2020 with especially high incidence in developed countries The five-year survival rate for breast cancer exceeds 90 and the average ten-year survival rate for women with non-metastatic invasive breast cancer is 84 Ferlay et al 2021
As a consequence there is an increasing number of women facing early and late side effects from breast cancer treatment One of the most common side effects is lymphedema with a reported incidence after cancer treatment around 30 MartÃnez Jaimez 2017 In Colombia it is estimated that 28 of women who undergo lymphadenectomy develop lymphedema Valencia Legarda et al 2020 Lymphedema is a chronic inflammatory disease that affects approximately 250 million people worldwide mostly associated with cancer treatment It can occur as a result of breast cancer surgery andor radiotherapy Riady-Aleuy et al 2022 Lymphedema is defined as the accumulation of protein-rich fluid in the interstitium secondary to abnormalities in the lymphatic transport system
According to the impact of lymphedema on the quality of life of individuals as well as the associated social and economic costs efforts must be made to prevent and treat it Various conservative strategies are used to reduce the risk of developing lymphedema and to manage it once it has developed Among the physiotherapeutic options is complex decongestive therapy CDT which is a conservative treatment that includes manual lymphatic drainage MLD compression therapy consisting of compression bandages compression sleeves or other types of compression garments skin care and lymph-reducing exercises LRE
Another treatment option is surgery which has traditionally been considered a last resort when conservative measures have failed However increasingly advanced surgical interventions are now being performed early in the disease process with the hope of preventing or reversing edema that arises from impaired lymphatic flow Markkula et al 2019 These interventions include liposuction lymph node transfer and lymphaticovenular anastomosis LVA The latter was first described in 1960 but it wasnt until 1989 in Japan and in 2020 in Colombia that it became the gold standard of microsurgery emerging as an innovative technique in our field increasingly used as a treatment for lymphedema rather than as a last-resort strategy when other treatments have failed Gupta et al 2021
As a consequence there is an increasing number of women facing early and late side effects from breast cancer treatment One of the most common side effects is lymphedema with a reported incidence after cancer treatment around 30 MartÃnez Jaimez 2017 In Colombia it is estimated that 28 of women who undergo lymphadenectomy develop lymphedema Valencia Legarda et al 2020 Lymphedema is a chronic inflammatory disease that affects approximately 250 million people worldwide mostly associated with cancer treatment It can occur as a result of breast cancer surgery andor radiotherapy Riady-Aleuy et al 2022 Lymphedema is defined as the accumulation of protein-rich fluid in the interstitium secondary to abnormalities in the lymphatic transport system
According to the impact of lymphedema on the quality of life of individuals as well as the associated social and economic costs efforts must be made to prevent and treat it Various conservative strategies are used to reduce the risk of developing lymphedema and to manage it once it has developed Among the physiotherapeutic options is complex decongestive therapy CDT which is a conservative treatment that includes manual lymphatic drainage MLD compression therapy consisting of compression bandages compression sleeves or other types of compression garments skin care and lymph-reducing exercises LRE
Another treatment option is surgery which has traditionally been considered a last resort when conservative measures have failed However increasingly advanced surgical interventions are now being performed early in the disease process with the hope of preventing or reversing edema that arises from impaired lymphatic flow Markkula et al 2019 These interventions include liposuction lymph node transfer and lymphaticovenular anastomosis LVA The latter was first described in 1960 but it wasnt until 1989 in Japan and in 2020 in Colombia that it became the gold standard of microsurgery emerging as an innovative technique in our field increasingly used as a treatment for lymphedema rather than as a last-resort strategy when other treatments have failed Gupta et al 2021
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None