Trial Title:
Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy
NCT ID:
NCT05793749
Condition:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Lymphedema
Treatment Effectiveness
Conditions: Official terms:
Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Lymphedema
Conditions: Keywords:
Lymphedema
Endometrial Neoplasms
Uterine Cervical Neoplasms
Treatment Effectiveness
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Random grouping (A:B=3:1): A: intervention group; B: nonintervention group
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Prophylactic lymphedema treatment
Description:
1. perform manual lymphatic drainage twice a week after the start of radiotherapy for a
total of 10 times, and wear lymphedema compression stockings after each manual
lymphatic drainage, 2. teach patients how to care for their skin. 3. perform
functional exercises for lymphedema of the lower extremities twice a day for 15 ~ 20
minutes each time. 4. follow up observation: before the start of radiotherapy, every
Friday during radiotherapy, and every 3 months after the end of radiotherapy, the
occurrence of lymphedema and related symptoms and quality of life were evaluated.
Arm group label:
Prophylactic lymphedema treatment
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 (A:B=3:1): 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
women's 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
patient's 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 Group（ECOG) score less than 2.
4. Expected survival time greater than 3 years.
5. Hemoglobin(Hb) greater than or equal to 70 g/L, white blood cells (WBC)greater than
or equal to 3.5 × 109 /L, neutrophils(ANC)greater than or equal to 1.5 × 109 /L,
platelets (PLT)greater than or equal to 80 × 109 /L.
6. serum alamine aminotransferase(ALT) and glutamic oxalacetic transaminase(AST) less
than 2 times the normal value and creatinine less than 1.5 times the normal value,
albumin greater than or equal to 35g/L.
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 1.3 and less than 0.5;
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 patient's safety or affect the patient's 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.
Criteria for eligibility:
Criteria:
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 Group（ECOG) score less than 2.
4.Expected survival time greater than 3 years. 5.Hemoglobin(Hb) greater than or equal to
70 g/L, white blood cells (WBC)greater than or equal to 3.5 × 109 /L,
neutrophils(ANC)greater than or equal to 1.5 × 109 /L, platelets (PLT)greater than or
equal to 80 × 109 /L.
6.serum alamine aminotransferase(ALT) and glutamic oxalacetic transaminase(AST) less than
2 times the normal value and creatinine less than 1.5 times the normal value, albumin
greater than or equal to 35g/L.
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 1.3 and less than 0.5;
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 patient's safety or affect the patient's completion of the study.
Gender:
Female
Gender based:
Yes
Gender description:
The indication was for patients with gynecological malignancy
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongling Zou, M.D.
Phone:
+8613657690699
Email:
cqzl_zdl@163.com
Start date:
April 1, 2023
Completion date:
July 29, 2026
Lead sponsor:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Source:
Chongqing University Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05793749
