Clinical trial NCT05300308: Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer
Official title: Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urogenital Cancer
Lower Limb Lymphedema
Nocturia
Nocturnal Polyuria
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)

Brief summary: After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence/ prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated.

Additionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).

Detailed description: Lymphoedema is caused by malfunction of the lymphatic system whether or not in combination with extra load on this system. Some patients develop lymphoedema after treatment for cancer: secondary lymphoedema or acquired lymphoedema. In 2018, 11 645 patients in Belgium were diagnosed with urogenital cancer cancer, including prostate and bladder cancer. A possible treatment consists of prostatectomy or cystectomy in combination with transperitoneal pelvic lymph node dissection. Patients who undergo treatment for cancer may develop lower limb lymphoedema or lymphoedema at midline. To the researchers knowledge, investigation of incidence of lower limb lymphoedema (LLL) is limited. Also, the prognostic variables for the development of LLL are unknown. Furthermore, no scientific evidence consists regarding which (combination of) clinical measurement methods are most sensitive to detect early LLL after transperitoneal pelvic lymph node dissection. Thresholds to identify subclinical lymphoedema in one or both legs are lacking. Besides lymphoedema in the lower limbs, treatment for cancer also often results in urinary problems. Especially urinary stress incontinence has been described in literature. However, in clinical practice, it is clear that prostatectomy is often associated with other urinary complications, as nocturia and nocturnal polyuria. To the researchers knowledge, there are no trials investigating the prognostic variables for the development of nocturia/ nocturnal polyuria after transperitoneal pelvic lymph node dissection for urogenital cancer.

Therefore, the researchers will execute a trial investigating the epidemiology (i. e incidence, prevalence and prognostic variables), detection methods and the feasibility of a trial about the early treatment of LLL after transperitoneal pelvic lymph node dissection for urogenital cancer. The epidemiology of LLL, nocturia and nocturnal polyuria will be investigated.

Participants: 150 patients undergoing a transperitoneal pelvic lymph node dissection for urogenital cancer will be included. These participants will be followed-up from baseline (pre-surgery) until 1 year post-surgery. All participants are evaluated at the University Hospitals Leuven, campus Gasthuisberg.

Procedure: The potential participant will be screened first to see if the patients meets the inclusion criteria. After signing the informed consent form, the participant will be followed in the prospective observational trial. The duration of the prospective observational trial is 2 years. Participants can be included until 1 year after the start of the trial.

Evaluation: There will be clinical evaluation of lymphoedema as well as treatment for lymphoedema. Participants in the prospective observational trial will be evaluated 4 times: baseline (pre-surgery), 6 weeks, 6 and 12 months post-surgery.

Treatment: All participants in the prospective observational trial receive standard of care. This consists out of information, skincare and exercises. The information about lymphoedema and its prevention is given by the physical therapist of the department of urology during the hospital stay. Skincare consists of daily moisturizer of legs and feet and prevention and care of wounds. The exercises are supervised by the home physical therapist. The frequency of the session at the physical therapist are gradually decreased.

Eligibility criteria: Inclusion Criteria:

* Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)
* Planned transperitoneal pelvic lymph node dissection or salvage lymph node dissection
* Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

* Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan
* Clinical signs of chronic venous insufficiency (CEAP C3-C6)
* History of lymph node dissection/ radiotherapy at the level of the pelvis or groin

Primary outcomes:
measure: Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 6 months post-surgery
timeFrame: 6 months post-surgery
measure: Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'baseline age' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of ' Baseline fat mass' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of ' Baseline physical activity level' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of ' Baseline educational level' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of ' baseline comorbidities' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of 'type of cancer' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Tumor stage' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Lymph node stage' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of 'number of positive lymph nodes' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of 'postoperative complications' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of 'type of lymph node dissection' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of 'number of lymph nodes removed' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Adjuvant Radiotherapy' for the development of lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Point prevalence rate of lower limb lymphoedema (i.e. number of patients with lower limb lymphoedema)
timeFrame: up to 12 months post-surgery
measure: Reliability of detection lower limb lymphoedema developing after the treatment of urogenital cancer
timeFrame: 12 months post-surgery
measure: Time efficiency of lymphoedema measurements
timeFrame: 12 months post-surgery
measure: Presence of limitations of lymphoedema measurements
timeFrame: 12 months post-surgery
measure: Validity of lymphoedema measurements
timeFrame: 12 months post-surgery
measure: diagnostic accuracy of the screening methods for lower limb lymphoedema
timeFrame: 12 months post-surgery
measure: Point prevalence rate of nocturia and nocturnal polyuria
timeFrame: up to 12 months post-surgery
measure: Prognostic value of 'baseline age' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'late-night fluid intake' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'late-night caffeine/alcohol use (3 hours before going to bed)' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'comorbidities' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'baseline fat mass' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'baseline physical activity' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'baseline educational level' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'type of cancer' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'tumor stage' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'lymph node stage' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'number of positive lymph nodes' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'postoperative complications' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'type of lymph node dissection' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'number of lymph nodes removed' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'radiotherapy' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'presence of postoperative drain' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
measure: Prognostic value of 'presence of lymphoedema' for the development of nocturia and nocturnal polyuria
timeFrame: 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, campus Gasthuisberg
state: Vlaanderen
Study officials:
affiliation: UZ Leuven
name: Nele Devoogdt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: