Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy

Stage III Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644408
• Other study ID #: MAIQF
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2014
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2019
• Source: The First Affiliated Hospital of Henan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. Can improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance put, chemotherapy, improve the quality of life, is widely used in tumor radiation and chemotherapy of terminally ill patients. But because of its vascular embolization, vaginal bleeding, arrhythmia and other serious complications, there is no unified standard.

The purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical chemoradiation curative effect and side effects, for rational use in the process of radiation and chemotherapy megestrol provide guidelines. A total of 210 patients will be accrued from China.The primary end point is quality of life (will be evaluated by EORTC QLQ-C30); the secondary end point is the pathological response after treatment and adverse events.

Description:

The investigators plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma and performed chemoradiotherapy from the Oct 2014. The patients will be divided into two groups.Experimental group：esophageal cancer patients with oral megestrol chemoradiation. Megestrol（Yining）：160mg/d，po,5 weeks in total，oen week before chemoradiotherapy and one week after chemoradiotherapy.

chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.Control group:

Esophageal cancer patients with chemoradiation without oral megestrol.chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.The primary end point is quality of life (will be evaluated by EORTC QLQ-C30); the secondary end point is the pathological response after treatment and adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 45-75years old

• Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0

• The patients have not received the surgery or chemo-radiotherapy.

• Hb=80g/L, absolute neutrophil count =1.5×109/L, Plt=90×109/L,

• ALT?AST=2.5*N,Cr=1.5*N.

• performance status score 0-2

Exclusion Criteria:

• Pregnant, lactating women

• Oxaliplatin or fluorouracil Allergy or metabolic disorders

• Radiotherapy contraindications

• History of organ transplantation

• Brain metastasis

• The peripheral nervous system disorders

• Severe infection

• Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding

• Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.

• Other malignant tumor in recent 5 years.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Stage II Esophageal Squamous Cell Carcinoma
• Stage III Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Megestrol(Yining)
Megestrol(Yining): 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.

Radiation:
• radiotherapy
radiotherapy (radiation): 50Gy in total,2 Gy/d,5d/w.

Other:
• chemotherapy
capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 weeks in total or capecitabine(Aibin) plus Oxaliplatin(Aiheng):65mg/m2,d1,8, 22, 29,I.V. or cisplatin: 75mg/m2 d1,29 5-Fu:750mg/m2CIV24h d1-4,d29-32. The 3 regimens were Randomly distributed to patients.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Henan University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (9)

Argilés JM, Anguera A, Stemmler B. A new look at an old drug for the treatment of cancer cachexia: megestrol acetate. Clin Nutr. 2013 Jun;32(3):319-24. doi: 10.1016/j.clnu.2013.01.004. Epub 2013 Jan 22. Review. — View Citation

Ezeoke CC, Morley JE. Pathophysiology of anorexia in the cancer cachexia syndrome. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):287-302. doi: 10.1002/jcsm.12059. Epub 2015 Oct 27. Review. — View Citation

Greig CA, Johns N, Gray C, MacDonald A, Stephens NA, Skipworth RJ, Fallon M, Wall L, Fox GM, Fearon KC. Phase I/II trial of formoterol fumarate combined with megestrol acetate in cachectic patients with advanced malignancy. Support Care Cancer. 2014 May;22(5):1269-75. doi: 10.1007/s00520-013-2081-3. Epub 2014 Jan 4. — View Citation

Gullett NP, Mazurak VC, Hebbar G, Ziegler TR. Nutritional interventions for cancer-induced cachexia. Curr Probl Cancer. 2011 Mar-Apr;35(2):58-90. doi: 10.1016/j.currproblcancer.2011.01.001. — View Citation

Hong S, Jeong IG, You D, Lee JL, Hong JH, Ahn H, Kim CS. Safety of megestrol acetate in palliating anorexia-cachexia syndrome in patients with castration-resistant prostate cancer. J Korean Med Sci. 2013 May;28(5):687-92. doi: 10.3346/jkms.2013.28.5.687. Epub 2013 May 2. — View Citation

Kanat O. Management of cancer cachexia (reply). Tumori. 2014 Jan-Feb;100(1):e1. doi: 10.1700/1430.15826. — View Citation

Madeddu C, Dessì M, Panzone F, Serpe R, Antoni G, Cau MC, Montaldo L, Mela Q, Mura M, Astara G, Tanca FM, Macciò A, Mantovani G. Randomized phase III clinical trial of a combined treatment with carnitine + celecoxib ± megestrol acetate for patients with cancer-related anorexia/cachexia syndrome. Clin Nutr. 2012 Apr;31(2):176-82. doi: 10.1016/j.clnu.2011.10.005. Epub 2011 Nov 1. — View Citation

Ordu C, Pilanci KN, Koksal UI, Okutur K, Saglam S, Tecimer C, Demir G. Can megestrol acetate induce thrombosis in advanced oncology patients receiving chemotherapy? Asian Pac J Cancer Prev. 2014;15(23):10165-9. — View Citation

Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (QoF)	evaluated by EORTC QLQ-C30 questionnaire	16 weeks
Secondary	pathological response	complete response(CR)	16 weeks
Secondary	adverse events		16 weeks