Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793749
Status:
RECRUITING
Last Update Posted:
2023-03-31
First Post:
2022-07-29
Brief Title:
Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy
Sponsor:
Chongqing University Cancer Hospital
Organization:
Chongqing University Cancer Hospital
Study Overview
Official Title:
Early Intervention to Prevent Gynecological Malignant Tumors Clinical Study of Lymphedema of the Lower Limbs in Patients With Radiotherapy After Lymphadenectomy
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective randomized controlled clinical trial of a single center in China and plans to enroll 400 patients
1 Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy
2 Random grouping AB31 A Prophylactic lymphoedema treatment B Standard care group
3 Preventive lymphedema health education was given to patients with gynecological malignant tumors without contraindications before surgery All patients were randomly divided into an intervention group and a nonintervention group The intervention group received preventive lymphedema treatment twice a week 10 times and the interval between the two treatments was not less than 48 hours and not more than 2 weeks The intervention measures included four parts manual lymphatic drainage skin care functional exercise and wearing lymphedema preventive compression stockings In the nonintervention group knowledge education and telephone follow-up were routinely conducted
4 All patients were evaluated for edema lymphedema symptoms and quality of life 1 day before radiotherapy every Friday during radiotherapy and every 3 months thereafter Bioelectrical impedance measurement and leg diameter measurement were used to evaluate edema the Gynecologic Cancer Lymphedema Questionnaire GCLQ was used to evaluate lymphedema symptoms and the EORTC Quality of Life Scale QLQ-C30 was used to evaluate quality of life followed up to 2 years after the end of lymphedema prophylaxis
1 Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy
2 Random grouping AB31 A Prophylactic lymphoedema treatment B Standard care group
3 Preventive lymphedema health education was given to patients with gynecological malignant tumors without contraindications before surgery All patients were randomly divided into an intervention group and a nonintervention group The intervention group received preventive lymphedema treatment twice a week 10 times and the interval between the two treatments was not less than 48 hours and not more than 2 weeks The intervention measures included four parts manual lymphatic drainage skin care functional exercise and wearing lymphedema preventive compression stockings In the nonintervention group knowledge education and telephone follow-up were routinely conducted
4 All patients were evaluated for edema lymphedema symptoms and quality of life 1 day before radiotherapy every Friday during radiotherapy and every 3 months thereafter Bioelectrical impedance measurement and leg diameter measurement were used to evaluate edema the Gynecologic Cancer Lymphedema Questionnaire GCLQ was used to evaluate lymphedema symptoms and the EORTC Quality of Life Scale QLQ-C30 was used to evaluate quality of life followed up to 2 years after the end of lymphedema prophylaxis
Detailed Description:
Research background Gynecological malignancies including cervical cancer ovarian cancer endometrial cancer vulvar cancer etc are important diseases threatening womens health worldwide and their main treatment methods are surgery and radiotherapy During surgery different numbers of lymph nodes are removed and lymphatic fluid and tissue exudate from the stump lymphatic vessels accumulate causing disruption of the original lymphatic circulation and obstruction of lymphatic fluid return which leads to lower limb edema The longer the radiotherapy lasts the more serious the phenomenon of collateral circulation will be and the lymphatic return pathway will be damaged resulting in lower limb lymphedema
Lower extremity lymphedema is a relatively common complication after treatment for gynecologic malignancies and it has been reported that approximately 20 million patients worldwide are affected by lower extremity lymphedema The overall incidence of lower extremity lymphedema after gynecologic malignancy treatment is about 25 and can be as high as 70 in special groups Age weight radiotherapy dose duration of postoperative radiotherapy tumor stage daily standing time number of lymph node dissection and co-infection are all risk factors for the occurrence of lower extremity lymphedema
Lymphedema is characterized by sunken edema at the beginning of the disease and progresses to include swelling numbness heaviness tissue fibrosis impaired movement and rough epidermal keratinization and increases the risk of inflammation of the lymphatic vessels and surrounding tissues and cellulitis Lower extremity lymphedema is a chronic progressive disease that is difficult to cure and has a negative impact on limb function daily life quality of life and psychological well-being
The treatment of lymphedema includes surgical treatment and conservative treatment The conservative treatment methods include Complex Decongestion Therapy CDT external application of Chinese herbal medicine and western medicine etc The Complex Decongestion Therapy CDT is the most widely used lymphedema treatment with the best efficacy internationally in recent years The treatment method but requires long-term or even lifelong care which brings huge psychological burden and economic pressure to the patients family Therefore lymphedema of the lower extremities should be prevented and preventive and therapeutic measures should be taken as early as possible to improve the quality of life of patients
Currently studies on lymphedema prevention have focused on interventions for breast cancer-related lymphedema while few studies have been reported on the prevention of lymphedema associated with gynecologic malignancies Research reported that early intervention with freehand lymphatic drainage technique could effectively prevent lower limb lymphedema and Research showed that full range of hip exercises could prevent lower limb lymphedema after cervical cancer surgery in addition some studies also found that freehand lymphatic drainage combined with Kegel training could prevent vulvar stage I lymphedema after cervical cancer surgery however these studies have some limitations such as small sample size and limited study content However these studies have limitations such as small sample size and limited study content Moreover there are no empirical studies on the prevention of lower extremity lymphedema in large samples and there is no unified standard for the prevention and management of lower extremity lymphedema Therefore in this study the investigators used an evidence-based approach and clinical experience to conduct a prospective study on the prevention of lower limb lymphedema in order to reduce the incidence of lower limb lymphedema improve patients quality of life and reduce their economic burden
Research objective
1 To understand the incidence of lymphedema after gynecological tumor surgery and radiotherapy and its impact on the quality of life of patients
2 Through preventive lymphedema treatment intervention reduce the proportion of lymphedema reduce the economic burden of patients and improve their quality of life
3 We aimed to find a more economical and effective method to treat gynecological malignant tumor lymphedema
Main outcome measures The incidence of lower extremity lymphedema after gynecological cancer surgery and radiotherapy and the incidence of lower extremity lymphedema after prophylactic lymphedema treatment
Secondary outcome measures quality of life incidence of lymphedema symptoms and progression-free survival PFS
Study population
Inclusion criteria
1 Gynecologic oncology patients undergoing radiotherapy after lymph node surgery who voluntarily participate in this study and sign an informed consent form
2 18 to 60 years old
3 Eastern Cooperative Oncology GroupECOG score less than 2
4 Expected survival time greater than 3 years
5 HemoglobinHb greater than or equal to 70 gL white blood cells WBCgreater than or equal to 35 109 L neutrophilsANCgreater than or equal to 15 109 L platelets PLTgreater than or equal to 80 109 L
6 serum alamine aminotransferaseALT and glutamic oxalacetic transaminaseAST less than 2 times the normal value and creatinine less than 15 times the normal value albumin greater than or equal to 35gL
7 Women of childbearing potential must have had a pregnancy test serum or urine within 7 days prior to enrollment and have a negative result and be willing to use an appropriate method of contraception for the duration of the trial
8 Ability to comply with the trial protocol as judged by the investigator
Exclusion criteria
1 Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed
2 Acute infection of any kind
3 Patients with lower extremity edema
4 pregnancy menstrual period
5 Recent major abdominal surgery determined by the investigator
6 Radiation colitis cystitis intestinal infection small bowel or large bowel diverticulitis or diverticulitis
7 Liver fibrosis
8 Abdominal aortic aneurysm
9 acute phlebitis
10 Severe arterial obstructive disease arterial ulcer ABPI ankle-brachial blood pressure index greater than 13 and less than 05
11 Severe peripheral neuropathy
12 Poor control of hypertension poor control of stroke and diabetes and severe bronchial asthma
13 Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent
14 Those with concomitant diseases or other special circumstances that seriously endanger the patients safety or affect the patients completion of the study
Subject Termination Criteria
1 The investigator believes that the treatment should be terminated from the perspective of the best benefit of the patients
2 There are intolerable adverse reactions after confirmation by the investigator
3 Failure to complete the treatment according to the cycle and time
4 The patient withdraws informed consent
Elimination criteria
1 Those who did not meet the standards and were mistakenly included
Lower extremity lymphedema is a relatively common complication after treatment for gynecologic malignancies and it has been reported that approximately 20 million patients worldwide are affected by lower extremity lymphedema The overall incidence of lower extremity lymphedema after gynecologic malignancy treatment is about 25 and can be as high as 70 in special groups Age weight radiotherapy dose duration of postoperative radiotherapy tumor stage daily standing time number of lymph node dissection and co-infection are all risk factors for the occurrence of lower extremity lymphedema
Lymphedema is characterized by sunken edema at the beginning of the disease and progresses to include swelling numbness heaviness tissue fibrosis impaired movement and rough epidermal keratinization and increases the risk of inflammation of the lymphatic vessels and surrounding tissues and cellulitis Lower extremity lymphedema is a chronic progressive disease that is difficult to cure and has a negative impact on limb function daily life quality of life and psychological well-being
The treatment of lymphedema includes surgical treatment and conservative treatment The conservative treatment methods include Complex Decongestion Therapy CDT external application of Chinese herbal medicine and western medicine etc The Complex Decongestion Therapy CDT is the most widely used lymphedema treatment with the best efficacy internationally in recent years The treatment method but requires long-term or even lifelong care which brings huge psychological burden and economic pressure to the patients family Therefore lymphedema of the lower extremities should be prevented and preventive and therapeutic measures should be taken as early as possible to improve the quality of life of patients
Currently studies on lymphedema prevention have focused on interventions for breast cancer-related lymphedema while few studies have been reported on the prevention of lymphedema associated with gynecologic malignancies Research reported that early intervention with freehand lymphatic drainage technique could effectively prevent lower limb lymphedema and Research showed that full range of hip exercises could prevent lower limb lymphedema after cervical cancer surgery in addition some studies also found that freehand lymphatic drainage combined with Kegel training could prevent vulvar stage I lymphedema after cervical cancer surgery however these studies have some limitations such as small sample size and limited study content However these studies have limitations such as small sample size and limited study content Moreover there are no empirical studies on the prevention of lower extremity lymphedema in large samples and there is no unified standard for the prevention and management of lower extremity lymphedema Therefore in this study the investigators used an evidence-based approach and clinical experience to conduct a prospective study on the prevention of lower limb lymphedema in order to reduce the incidence of lower limb lymphedema improve patients quality of life and reduce their economic burden
Research objective
1 To understand the incidence of lymphedema after gynecological tumor surgery and radiotherapy and its impact on the quality of life of patients
2 Through preventive lymphedema treatment intervention reduce the proportion of lymphedema reduce the economic burden of patients and improve their quality of life
3 We aimed to find a more economical and effective method to treat gynecological malignant tumor lymphedema
Main outcome measures The incidence of lower extremity lymphedema after gynecological cancer surgery and radiotherapy and the incidence of lower extremity lymphedema after prophylactic lymphedema treatment
Secondary outcome measures quality of life incidence of lymphedema symptoms and progression-free survival PFS
Study population
Inclusion criteria
1 Gynecologic oncology patients undergoing radiotherapy after lymph node surgery who voluntarily participate in this study and sign an informed consent form
2 18 to 60 years old
3 Eastern Cooperative Oncology GroupECOG score less than 2
4 Expected survival time greater than 3 years
5 HemoglobinHb greater than or equal to 70 gL white blood cells WBCgreater than or equal to 35 109 L neutrophilsANCgreater than or equal to 15 109 L platelets PLTgreater than or equal to 80 109 L
6 serum alamine aminotransferaseALT and glutamic oxalacetic transaminaseAST less than 2 times the normal value and creatinine less than 15 times the normal value albumin greater than or equal to 35gL
7 Women of childbearing potential must have had a pregnancy test serum or urine within 7 days prior to enrollment and have a negative result and be willing to use an appropriate method of contraception for the duration of the trial
8 Ability to comply with the trial protocol as judged by the investigator
Exclusion criteria
1 Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed
2 Acute infection of any kind
3 Patients with lower extremity edema
4 pregnancy menstrual period
5 Recent major abdominal surgery determined by the investigator
6 Radiation colitis cystitis intestinal infection small bowel or large bowel diverticulitis or diverticulitis
7 Liver fibrosis
8 Abdominal aortic aneurysm
9 acute phlebitis
10 Severe arterial obstructive disease arterial ulcer ABPI ankle-brachial blood pressure index greater than 13 and less than 05
11 Severe peripheral neuropathy
12 Poor control of hypertension poor control of stroke and diabetes and severe bronchial asthma
13 Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent
14 Those with concomitant diseases or other special circumstances that seriously endanger the patients safety or affect the patients completion of the study
Subject Termination Criteria
1 The investigator believes that the treatment should be terminated from the perspective of the best benefit of the patients
2 There are intolerable adverse reactions after confirmation by the investigator
3 Failure to complete the treatment according to the cycle and time
4 The patient withdraws informed consent
Elimination criteria
1 Those who did not meet the standards and were mistakenly included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None