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This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the level of body weight improvement of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanocrystalline Megestrol Acetate + PD-1/L1 inhibitor + chemotherapy | Experimental | Nanocrystalline Megestrol Acetate Oral Suspension+ PD-1/L1 inhibitor combined with chemotherapy |
|
| PD-1/L1 inhibitor + chemotherapy | Placebo Comparator | PD-1/L1 inhibitor combined with chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanocrystalline Megestrol Acetate Oral Suspension | Drug | Nanocrystalline Megestrol Acetate Oral Suspension (125 mg/mL) was administered to the study group at 5 mL orally once daily (equivalent to 625 mg/day) until disease progression or completion of 12 weeks Other: PD-1/L1 inhibitor combined with chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| change in body weight | To evaluate the change in body weight of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC. | a 12-week period |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate | To evaluate the Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate (based on RECIST v1.1) of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC. | 1-year period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yong chang Zhang | Contact | 13873123436 | zhangyongchang@csu.edu.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8558188 | Background | Rowland KM Jr, Loprinzi CL, Shaw EG, Maksymiuk AW, Kuross SA, Jung SH, Kugler JW, Tschetter LK, Ghosh C, Schaefer PL, Owen D, Washburn JH Jr, Webb TA, Mailliard JA, Jett JR. Randomized double-blind placebo-controlled trial of cisplatin and etoposide plus megestrol acetate/placebo in extensive-stage small-cell lung cancer: a North Central Cancer Treatment Group study. J Clin Oncol. 1996 Jan;14(1):135-41. doi: 10.1200/JCO.1996.14.1.135. | |
| 19774117 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| PD-1/L1 inhibitor combined with chemotherapy | Other | PD-1/L1 inhibitor combined with chemotherapy |
|
| change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12) |
To evaluate the change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12) of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC. An increase of ≥ 4 points in the A/CS-12 scale, or an A/CS-12 scale score of ≥ 37 points, indicates appetite improvement. If the above criteria are not met, it indicates no appetite improvement. |
| a 12-week period |
| change in lean body mass | To evaluate the change in lean body mass of megestrol acetate combined with standard treatment | a 12-week period |
| Number of completed treatment cycles and occurrence of treatment dose reduction | To evaluate the number of completed treatment cycles and the occurrence of treatment dose reduction of megestrol acetate plus standard therapy versus standard therapy alone as first-line treatment for non-small cell lung cancer (NSCLC). | a 12-week period |
| Background |
| Deschamps B, Musaji N, Gillespie JA. Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension. Int J Nanomedicine. 2009;4:185-92. doi: 10.2147/ijn.s6308. Epub 2009 Sep 10. |
| 25893430 | Background | Li Y, Song CK, Kim MK, Lim H, Shen Q, Lee DH, Yang SG. Nanomemulsion of megestrol acetate for improved oral bioavailability and reduced food effect. Arch Pharm Res. 2015 Oct;38(10):1850-6. doi: 10.1007/s12272-015-0604-9. Epub 2015 Apr 18. |
| 33306105 | Background | Treger S, Ackerman S, Kaplan V, Ghanem S, Nadir Y. Progestin type affects the increase of heparanase level and procoagulant activity mediated by the estrogen receptor. Hum Reprod. 2021 Jan 1;36(1):61-69. doi: 10.1093/humrep/deaa263. |
| 34513071 | Background | Fedotcheva TA. Clinical Use of Progestins and Their Mechanisms of Action: Present and Future (Review). Sovrem Tekhnologii Med. 2021;13(1):93-106. doi: 10.17691/stm2021.13.1.11. Epub 2021 Feb 28. |
| 31228648 | Background | Trestini I, Gkountakos A, Carbognin L, Avancini A, Lanza M, Molfino A, Friso S, Corbo V, Tortora G, Scarpa A, Milella M, Bria E, Pilotto S. Muscle derangement and alteration of the nutritional machinery in NSCLC. Crit Rev Oncol Hematol. 2019 Sep;141:43-53. doi: 10.1016/j.critrevonc.2019.06.007. Epub 2019 Jun 15. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |