ower Extremity Lymphedema Incidence and Quality of Life Following Surgery or Concurrent Chemoradiation for Gynecologic Cancer : A Prospective Trial
Recruiting
- Conditions
- eg edemaGynecologic cancerUnderwent surgical staging with pelvic lymph node dissectionLower extremity lymphedemaCervical cancer, Endometrial cancer, Quality of life in gynecologic cancer
- Registration Number
- TCTR20240409005
- Lead Sponsor
- none
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 226
Inclusion Criteria
1. Patients age 18 to 90 years, not pregnant or breastfeed
2. Diagnosed of Endometrial cancer or cervical cancer (histological proved) and had underwent CT or MRI for diagnosis
3. Not received any main treatment except the conization
4. Received main treatment as surgical staging with pelvic lymphadenectomy or concurrent chemoradiation
5. Be able to answer the questionnaire and to assess leg volume measurement
6. agree to participate
Exclusion Criteria
1. Diagnosed of DVT or leg cellulitis
2. Alteration of conciousness or unable to answer the questionnaire
3. unable to communicate in Thai
4. Stage IV cancer with main treatment of chemotherapy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence ot lower extremity lymphedema in each gynecologic cancer baseline and 4-6 weeks after primary treatment, and 3 months post treament (in some patients) measurement of leg volume
- Secondary Outcome Measures
Name Time Method Quality of life assessment baseline, 4-6 weeks after primary treatment, 3 months after treatment (in some patients) Questionnaire EORTC QLQ-CX24 (cervical cancer) or EORTC QLQ-EN24 (endometrial cancer) ,validate lymphedema questionnaire baseline, 4-6 weeks post treatment, 3 months post treatment in some patient Questionnaire of 13-item lymphedema compare to leg volume ,factors associated with lymphedema - logistic regression analysis