Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

NCT05793749 | Recruiting

• 1 other identifier: CQGOG0108
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized, controlled clinical trial of a single center in China and plans to enroll 400 patients.

1. 1.Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy;
2. 2.Random grouping (A:B=3:1): A. Prophylactic lymphoedema treatment; B. Standard care group;
3. 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. 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.

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Lymphedema; Treatment Effectiveness

Keywords

Lymphedema; Endometrial Neoplasms; Uterine Cervical Neoplasms; Treatment Effectiveness

Outcome Measures

Primary Outcomes (2)

• Incidence of lymphedema

  The incidence of lower extremity lymphedema after gynecological cancer surgery and radiotherapy, and the incidence of lower extremity lymphedema after prophylactic lymphedema treatment.

  Incidence of lymphedema in the prophylactic lymphedema treatment group and the standard treatment group at 2 years after the end of radiotherapy

• Quality of life of patients

  The quality of life of cancer patients (QLQ-C30) was used to assess the quality of life of patients. Including the overall quality of life subscale, functional subscale, symptom subscale, and individual test items. The higher the overall quality of life subscale and the functional subscale score, the better the quality or function. The more severe the symptoms.

  Quality of life QLQ-C30 scores for the prophylactic lymphedema treatment group and the standard treatment group at 2 years after the end of radiotherapy

Secondary Outcomes (2)

• Subjective feelings

  Quality of life GCLQ scores for the prophylactic lymphedema treatment group and the standard treatment group at 2 years after the end of radiotherapy

• 2-year progression-free survival,2-year PFS

  2-year PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause within 2 years

Study Arms (2)

Prophylactic lymphedema treatment

EXPERIMENTAL

Prophylactic lymphedema treatment：The lymphedema prophylaxis treatment consists of four parts:manual lymphatic drainage, skin care, functional exercise, and wearing lymphedema preventive compression stockings. The prophylactic lymphedema treatment group receives lymphedema prophylaxis twice a week for a total of 10 sessions, each requiring an interval of at least 48 hours but no more than 2 weeks.

Behavioral: Prophylactic lymphedema treatment

Standard of care

NO INTERVENTION

Standard of care，includeIn knowledge education and telephone follow-up were routinely conducted.

Interventions

Prophylactic lymphedema treatment BEHAVIORAL

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.

Prophylactic lymphedema treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: The indication was for patients with gynecological malignancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gynecologic oncology patients undergoing radiotherapy after lymph node surgery who voluntarily participate in this study and sign an informed consent form.
• 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.
• 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.
• 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.
• Ability to comply with the trial protocol, as judged by the investigator.

You may not qualify if:

• Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed;
• Acute infection of any kind;
• Patients with lower extremity edema;
• pregnancy, menstrual period;
• Recent major abdominal surgery (determined by the investigator);
• Radiation colitis, cystitis, intestinal infection, small bowel or large bowel diverticulitis or diverticulitis;
• Liver fibrosis;
• Abdominal aortic aneurysm;
• acute phlebitis;
• Severe arterial obstructive disease, arterial ulcer, ABPI (ankle-brachial blood pressure index) greater than 1.3 and less than 0.5;
• Severe peripheral neuropathy;
• Poor control of hypertension, poor control of stroke and diabetes, and severe bronchial asthma;
• Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent;
• Those with concomitant diseases or other special circumstances that seriously endanger the patient's safety or affect the patient's completion of the study.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Related Publications (13)

• Cortez AJ, Tudrej P, Kujawa KA, Lisowska KM. Advances in ovarian cancer therapy. Cancer Chemother Pharmacol. 2018 Jan;81(1):17-38. doi: 10.1007/s00280-017-3501-8. Epub 2017 Dec 16.

  PMID: 29249039 RESULT

• Minion LE, Tewari KS. Cervical cancer - State of the science: From angiogenesis blockade to checkpoint inhibition. Gynecol Oncol. 2018 Mar;148(3):609-621. doi: 10.1016/j.ygyno.2018.01.009. Epub 2018 Feb 3.

  PMID: 29666026 RESULT

• 李可心，孙洪赞，辛军，等.早期宫颈癌盆腔淋巴结转移危险因素及PET/CT诊断[J].中国医学影像技术，2018，34: 265-269.

  RESULT

• 朱认真，张开宇，李倩.宫颈癌术后放疗致下肢淋巴水肿及神经电生理功能的影响及机制分析[J]. 实用癌症杂志, 2020，35: 121-124

  RESULT

• Dessources K, Aviki E, Leitao MM Jr. Lower extremity lymphedema in patients with gynecologic malignancies. Int J Gynecol Cancer. 2020 Feb;30(2):252-260. doi: 10.1136/ijgc-2019-001032. Epub 2020 Jan 7.

  PMID: 31915136 RESULT

• Jiang X, Nicolls MR, Tian W, Rockson SG. Lymphatic Dysfunction, Leukotrienes, and Lymphedema. Annu Rev Physiol. 2018 Feb 10;80:49-70. doi: 10.1146/annurev-physiol-022516-034008. Epub 2017 Oct 13.

  PMID: 29029593 RESULT

• 张赫,孔为民.宫颈癌治疗后下肢淋巴水肿预防进展[J].国际妇产科学杂志,2021,48(02):139-143.

  RESULT

• Fukushima T, Tsuji T, Sano Y, Miyata C, Kamisako M, Hohri H, Yoshimura C, Asakura M, Okitsu T, Muraoka K, Liu M. Immediate effects of active exercise with compression therapy on lower-limb lymphedema. Support Care Cancer. 2017 Aug;25(8):2603-2610. doi: 10.1007/s00520-017-3671-2. Epub 2017 Apr 6.

  PMID: 28386788 RESULT

• 中华整形外科学分会淋巴水肿学组.外周淋巴水肿诊疗的中国专家共识[J].中华整形外科杂志,2020,36(4):355-360.

  RESULT

• 梁笑媚,黄伟斌.腋窝反向淋巴作图预防乳腺癌术后上肢水肿的预防应用研究[J].中国卫生标准管理,2021.12(15):58-60.

  RESULT

• 白巧玲,王星.宫颈癌术后早期徒手淋巴引流预防术后下肢淋巴水肿[J].现代肿瘤医学,2021,29(19):3440-3442.

  RESULT

• Carter J, Raviv L, Appollo K, Baser RE, Iasonos A, Barakat RR. A pilot study using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) as a clinical care tool to identify lower extremity lymphedema in gynecologic cancer survivors. Gynecol Oncol. 2010 May;117(2):317-23. doi: 10.1016/j.ygyno.2010.01.022. Epub 2010 Feb 16.

  PMID: 20163847 RESULT

• Taarnhoj GA, Kennedy FR, Absolom KL, Baeksted C, Vogelius IR, Johansen C, Velikova G, Pappot H. Comparison of EORTC QLQ-C30 and PRO-CTCAE Questionnaires on Six Symptom Items. J Pain Symptom Manage. 2018 Sep;56(3):421-429. doi: 10.1016/j.jpainsymman.2018.05.017. Epub 2018 May 25.

  PMID: 29807157 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Dongling Zou, Doctor

CONTACT

+8613657690699; cqzl_zdl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor，Doctor

Model Details: Random grouping (A:B=3:1): A: intervention group; B: nonintervention group

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: March 31, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): July 29, 2026
• Study Completion (Estimated): July 29, 2026
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)