Abstract 453P
Background
Evidence shows megestrol acetate (MA) may be a potential antiemetics for preventing chemotherapy-induced nausea and vomiting (CINV). While no persuasive clinic trails were performed to validate the efficacy and safety of MA. Here we designed a phase II trial to assess the efficacy of palonosetron plus megestrol acetate versus palonosetron plus dexamethasone (DEX) in preventing chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy (MEC) regimens.
Methods
This was a multicenter, randomized, crossover, phases II clinical trial at West China hospital and West China Fourth hospital of Sichuan University. The eligible patients were recruited to the DEX-MA group and MA-DEX group by using computer-generated random number table. DEX-MA group received palonosetron and dexamethasone for first chemotherapy circle and then received palonosetron and megestrol acetate for second circle. The MA-DEX group received the treatment in the reverse order. Evaluating efficacy and quality of life of patients of these two regimens relatively. The primary endpoint was complete response (CR). This trial has registered with Chinese Clinical Trial Register (ChiCTR2000037447).
Results
Between June 2020 and March 2021, sixty-one patients were eventually evaluated in the study. Thirty-two patients were randomized in the DEX-MA group and 29 in the MA-DEX group. Of all subjects, 56% were male, and 44% were female. CR rates showed no significant difference in acute phase (DEX vs. MA, 85.25% vs. 85.25%, P=1.000), delayed phase (DEX vs. MA, 81.97% vs. 83.61%, P=0.810), overall phase (DEX vs. MA, 75.41% vs. 73.77%, P=0.835). Quality of life (QOL) showed significant differences in dyspnea symptom (P=0.000) and appetite loss symptom (P=0.021).
Conclusions
Megestrol acetate may have equivalent efficacy to dexamethasone in the treatment of moderately emetogenic regimen chemotherapy induced nausea and vomiting, and no obvious adverse reactions occurred. Compared with dexamethasone, megestrol acetate can significantly improve the quality of life, especially in terms of decreasing the dyspnea and appetite loss.
Clinical trial identification
ChiCTR2000037447, 2020-08-28.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
462P - Cognitive function of survivors with non-central nervous system cancer and its correlates: A community rehabilitation perspective
Presenter: Ann Kuo
Session: Poster Display
Resources:
Abstract
463P - The use of antipsychotic for managing delirium in patients with cancer
Presenter: Natasya Reina
Session: Poster Display
Resources:
Abstract
464P - The prevalence and correlates of frailty and pre-frailty in elderly patients with breast cancer: A cross-sectional study from China
Presenter: Min Xiao
Session: Poster Display
Resources:
Abstract
465P - Oncological care needs of people with mental illness: A single institution experience in Australia
Presenter: Hui Ling Yeoh
Session: Poster Display
Resources:
Abstract
466P - Identification of patient satisfaction predictors among women attending oncology daycare unit using validated survey questionnaire (PSS Tool): An institutional experience in central India
Presenter: Rajesh Patidar
Session: Poster Display
Resources:
Abstract
467P - Evaluation of the effectiveness of a cluster management model based on evidence-based concepts in oncology nutrition case management
Presenter: Li He
Session: Poster Display
Resources:
Abstract
468P - The patterns of use of Traditional Chinese Medicine (TCM) in cancer patients in Hong Kong
Presenter: Olivia L T Chan
Session: Poster Display
Resources:
Abstract
469P - The need of special care for adolescent and young adult (AYA) cancer survivors: Perspective from oncologists in India
Presenter: Nandini Menon
Session: Poster Display
Resources:
Abstract
470TiP - Randomised controlled trial to evaluate the efficacy and safety of moisturising creams with or without palm-oil-derived vitamin E concentrate in addition to urea-based cream or urea-based cream alone in Capecitabine-associated Palmar-Plantar Erythrodysesthesia (ECaPPE)
Presenter: Pei-Jye Voon
Session: Poster Display
Resources:
Abstract
471TiP - A group sequential, response-adaptive randomized double-blinded clinical trial to evaluate add-on olanzapine plus pregabalin to prevent chemotherapy-induced nausea and vomiting (CINV ) in patients belonging to low socio-economic status
Presenter: Mathan Ramasubbu
Session: Poster Display
Resources:
Abstract