Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study).

BACKGROUND: Advances in the treatment of gynecological cancers have led to increased survival in patients with gynecological cancers. Nevertheless, patients may still experience prevalent long term consequences, including lower limb lymphedema, depression, anxiety, sexual dysfunction, malnutrition, and sarcopenia, that negatively impact their quality of life. PRIMARY OBJECTIVE: To assess the impact on self-perceived quality of life of systematic screening and early treatment of lower limb lymphedema, anxiety and depression, sexual dysfunction, and sarcopenia and malnutrition compared with standard practice. STUDY HYPOTHESIS: Systematic screening with validated questionnaires leading to early diagnosis and treatment of side effects will have a positive impact on quality of life. TRIAL DESIGN: This prospective clinical trial will randomize candidates for surgery to either standard of care or systematic screening every 2 months for 2 years. Quality of life data will be collected every 4 months. After randomization, patients in the control group will follow standard usual care. Their screening scales will not be considered. In the experimental group, positive screenings will generate an alert to the physician, and patients will be referred to the corresponding specific area (rehabilitation unit, psycho-oncology unit, sexual health unit, or nutrition unit). MAJOR INCLUSION AND XCLUSION CRITERIA: Patients aged ≥18 years with ovarian, cervical, or endometrial cancer who are candidates for surgery will be included. PRIMARY ENDPOINT: Self-reported quality of life questionnaire score. SAMPLE SIZE: 168 patients will be randomized to detect a difference of 6 points in the questionnaires. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Study completion is estimated for January 2026 and the results will be presented in May 2026. TRIAL REGISTRATION NUMBER: NCT05918770.

Intensive complex physical therapy combined with intermittent pneumatic compression versus Kinesio taping for treating breast cancer-related lymphedema of the upper limb: A randomised cross-over clinical trial.

OBJECTIVE: The objective of this study is to compare the effectiveness of complex physical therapy combined with intermittent pneumatic compression (CPT + IPC) versus Kinesio taping (KT) for breast cancer-related lymphedema. METHODS: A cross-over clinical trial was conducted in 43 women with lymphedema. All participants received two interventions: CPT + IPC and KT, both lasting 3 weeks and a washout period. The main outcome variable was the relative volume change (RVC). The secondary variables were Satisfaction Questionnaire about Textile Therapeutic Devices used for Breast Cancer-Related Lymphedema, Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, motion range of upper limb and lymphedema-related symptoms. RESULTS: The RVC reduction was greater with CPT + IPC (-2.2%, SD = 4.7) versus KT (-0.9%, SD = 1.7) (P = 0.002). KT was more satisfactory than multilayer bandaging (8.9 points difference, P < 0.001) and improved DASH score more than CPT + IPC (14.3 points difference, P = 0.002). Regarding motion ranges, only shoulder movements showed significant improvement with CPT + IPC compared with KT (differences between 5.6° and 11.4°). Of the symptoms assessed, only pain reduction showed a significant improvement with KT versus CPT + IPC (0.5 points, P = 0.035). CONCLUSIONS: CPT + IPC achieved higher RVC and greater improvement in th shoulder motion range than KT. Conversely, KT was more satisfactory than multilayer bandaging, obtained better DASH scores and relieved pain more than CPT + IPC. CLINICAL REGISTRATION: ClinicalTrial registration number: NCT03051750 (date of registration 14 February 2017).