Effect of a Structured Teaching Module Including Intensive Prophylactic Measures on Reducing the Incidence of Capecitabine-Induced Hand-Foot Syndrome: Results of a Prospective Randomized Phase III Study
| Autor: | Neeta Chavan, Ashwin Desouza, Jimmy Mirani, Sudeep Gupta, Vikas Ostwal, Sarika Mandavkar, Anant Ramaswamy, Chaitali Nashikkar, Avanish Saklani, Tarachand Gupta, Akhil Kapoor, Kalaivani Murugan |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Cancer Research
medicine.medical_specialty medicine.medical_treatment Capecitabine 03 medical and health sciences 0302 clinical medicine Quality of life Internal medicine Clinical endpoint medicine Humans Prospective Studies 030212 general & internal medicine Chemotherapy integumentary system business.industry Clinical Trial Results Incidence Incidence (epidemiology) humanities Clinical trial Oncology nursing Oncology 030220 oncology & carcinogenesis Quality of Life Hand-Foot Syndrome Fluorouracil Complication business medicine.drug |
| Zdroj: | Oncologist |
| ISSN: | 1549-490X 1083-7159 |
| DOI: | 10.1634/theoncologist.2020-0698 |
| Popis: | Lessons Learned A structured teaching module including intensive prophylactic measures to alleviate hand-foot syndrome (HFS) during capecitabine therapy is feasible but ineffective at protecting patients from HFS. Pharmacologic therapeutic interventions should be investigated for the management of this complication. Background Capecitabine-induced hand-foot syndrome (HFS) has a detrimental effect on quality of life. The effect of a structured teaching module including intensive prophylactic measures was evaluated. Methods This non-crossover phase III double-blinded clinical trial randomized patients in a 1:1 ratio to either a control group or to a group administered a structured teaching model including intensive prophylactic measures on HFS administered by a trained oncology nurse at regular intervals (case) versus standard information on HFS care administered by treating clinician (control). The primary endpoint was comparison of fraction of patients in both arms developing at least grade 2 HFS. Results Between June 15, 2016, and April 4, 2018, 280 patients (140 to case and 140 to control) were enrolled. The median number of capecitabine chemotherapy cycles was eight; 269 patients (96%) were evaluable for HFS, of whom 89 patients (33.08%) developed at least grade 2 HFS (grade 2 HFS, 73 patients [26.1%]; grade 3 HFS, 16 patients (5.7%}). There was no difference in at least grade 2 HFS between evaluable case and control arms of the study (control group, 45/135 [33.3%]; case, 44/134 [32.8%]; p = .93). Conclusion The use of a structured teaching module including intensive prophylactic measures was feasible, but this did not reduce the incidence and severity of capecitabine-induced HFS. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text