Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer



Status:Recruiting
Conditions:Breast Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Women's Studies, Endometrial Cancer
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:June 2012

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The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

This clinical trial studies lymphedema after surgery in patients with endometrial cancer,
cervical cancer, or vulvar cancer. Collecting information over time about how often
lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer,
cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan
the best treatment.

PRIMARY OBJECTIVES:

I. To prospectively estimate the incidence of lower extremity lymphedema in patients
undergoing radical surgery with a concurrent lymphadenectomy with a concurrent
lymphadenectomy for a gynecologic malignancy.

II. To identify risk factors for the development of lower extremity lymphedema following
radical surgery for each of three types of gynecologic malignancy and to develop a
corresponding predictive model.

SECONDARY OBJECTIVES:

I. To identify the effect that lower extremity lymphedema has on quality of life (QOL) (as
measured with Functional Assessment of Cancer Therapy - General [FACT-G] + disease specific
subscale), psychological adjustment (as measured with Impact of Events Scale [IES] and
Functional Assessment of Chronic Illness Therapy [FACIT] body image items) and physical
disability (of lower extremity as measured with Lower Extremity Functional Scale [LEFS]) and
physical function(as measured by FACT-Functional Wellbeing [FW] subscale, FACIT disease
specific items & patient-reported outcomes measurement information system [PROMIS] items)
and to investigate potential protective mechanisms (FACT-Social Wellbeing [SW] subscale and
patient characteristics).

II. To explore if patient self-reported symptoms (as measured with the lymphedema [LE]
Symptom Measure [Cancer Lymphedema Questionnaire (GCLQ)]) are associated with the
development of lymphedema in patients undergoing radical surgery for gynecologic malignancy.

TERTIARY OBJECTIVES:

I. To explore the effect of moderate or severe lymphedema (primary endpoint) on QOL
outcomes, as measured by the FACT-General (G) questionnaire.

OUTLINE:

Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed
immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy.

Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral
pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open
route.

Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a
total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy
+/- para-aortic node sampling.

Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24
months.

Inclusion Criteria:

- Patients will be registered into three distinct groupings, and each group will be
analyzed as a separate study:

- Patients who will undergo or have undergone hysterectomy/bilateral
salpingo-oophorectomy (BSO) and pelvic lymphadenectomy +/- para-aortic node
sampling via open or laparoscopic technique for clinical stage I-II or surgical
stage I-III uterine carcinoma, including those receiving postoperative adjuvant
therapy; patients enrolling after surgery may have a pathologic stage of I-III
OR

- Patients who will undergo or have undergone radical hysterectomy or
trachelectomy and pelvic lymphadenectomy +/- para-aortic node sampling via open
or laparoscopic technique for clinical stage IA-IIA cervical carcinoma,
including those receiving postoperative adjuvant therapy OR

- Patients with vulvar cancer who will undergo or have undergone definitive
surgery for primary stage I-IV vulvar cancer who will or have received a radical
vulvectomy or radical local excision with concurrent unilateral or bilateral
inguinal or inguinal-femoral lymphadenectomy; patients who are going to receive
multi-modality therapy (radiation +/-chemotherapy) after undergoing surgery are
eligible; patients may undergo sentinel node mapping as long as it is followed
by a full lymphadenectomy

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- Patients must have a serum albumin level of >= 3.0 within 14 days of entry

- Surgery must occur within 5 business days before study entry or within eight weeks
after study entry

Exclusion Criteria:

- Patients with any prior clinical history of lower extremity lymphedema

- Patients who have a history of congestive heart failure, chronic renal disease, or
chronic liver disease

- Patients with a prior history of chronic lower extremity swelling

- Patients with a Gynecologic Oncology Group (GOG) performance grade of 3 or 4

- Patients with a history of other invasive malignancies if their previous cancer
treatment included any of the surgical procedures

- Patients who have had prior lower extremity vascular surgery (arterial or venous)

- Patients who have had prior pelvic, abdominal, inguinal, or lower extremity radiation
therapy

- Patients who have had or are going to receive another elective surgery during the
same operative event as their pelvic (cervical or uterine cancers) or inguinal
(vulvar) lymphadenectomy

- Patients cannot be enrolled on the trial unless there is at least one person at the
participating site who has been trained in performing limb measurements

- Patients who do not undergo or have not undergone the lymphadenectomy portion of the
procedure

- Patients who enter the study and then undergo sentinel node biopsy without the
intention of undergoing complete lymphadenectomy
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Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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