Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer

NCT03025152 | Terminated DMC

• 1 other identifier: JXUTCM-EBM-02
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving symptoms and indicators in patients with spleen qi deficiency and radical gastrectomy for gastric cancer.

Conditions

Gastric Cancer; Gastrointestinal Disease

Keywords

Hou Gu Mi Xi; Shen Ling Bai Zhu San; radical gastrectomy; gastric cancer; traditional Chinese medicine; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale)

  Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)

  At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks

Secondary Outcomes (14)

• Qualitative assessment of changes in total scores of SQD scale from baseline

  At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks

• Changes in scores of each item of SQD scale from baseline

  At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks

• Changes from baseline in total scores of Short Form 36 (SF-36) (Units on a scale)

  At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks

• Changes from baseline in scores of subitems in Short Form 36 (SF-36) (Units on a scale)

  At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks

• Changes from baseline in scores of Eastern Cooperative Oncology Group (ECOG) Performance Status (Units on a scale)

  At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks

Study Arms (2)

Hou Gu Mi Xi

EXPERIMENTAL

Patients in this arm receive Hou Gu Mi Xi, with an oral dose of 10 g/day during entire follow up period (2 years).

Dietary Supplement: Hou Gu Mi Xi

placebo

PLACEBO COMPARATOR

Patients in this arm receive placebo, with an oral dose of 10 g/day during entire follow up period (2 years).

Other: placebo

Interventions

Hou Gu Mi Xi DIETARY_SUPPLEMENT

Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.

Hou Gu Mi Xi

placebo OTHER

The placebo has same appearance, taste and smell as Hou Gu Mi Xi.

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient should be diagnosed as gastric cancer by pathology and have received radical gastrectomy. They should finish the following radiotherapy and chemotherapy and the treatment for surgical complications (such as leak, stricture, and marginal ulcer).
• Patient should be constitution of spleen qi deficiency, that is, meet two primary symptoms of spleen deficiency + two primary symptoms of qi deficiency, or meet two primary symptoms of spleen deficiency + one primary symptoms of qi deficiency + one auxiliary symptoms, or meet one primary symptoms of spleen deficiency + one primary symptoms of qi deficiency + two secondary symptoms + one auxiliary symptoms as follow:
• Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose, diarrhea); c) abdominal distention after meal or afternoon
• Main symptoms of qi deficiency: a) fatigue; b) tired mind and taciturnity
• Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, polysialia; b) abdominal pain, as a result either patients like warm or press, or remit after meal, or occur when work; c) nausea and vomiting; d) fullness in stomach; e) abnormal bowel sounds; f) lean or puffiness; g) sallow complexion; h) powerless defecation weakness; i) edema
• Auxiliary symptoms: pale or swollen or teeth-printed tongue with thin and white fur
• Age ranges from 18 to 70 years; both male and female
• Patient should be in fair performance status, indicated by a score of Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Sign the informed consent

You may not qualify if:

• Stage IV gastric cancer according to the Japanese classification criteria \[16\]
• Impaired liver function (total bilirubin \> 2 × upper limit of normal (ULN), alanine transaminase \> 2 × ULN, or aspartate aminotransferase \> 2 × ULN), kidney function (serum creatinine \> 2 × ULN), or hematopoiesis (neutrophil counts \< 0.5×109/L or, thrombocyte counts \< 20×109/L or, absolute reticulocyte counts \< 15×109/L)
• Obviously abnormal electrocardiogram
• Severe mental disorders
• Other severe diseases (e.g. multiple organ failure, HIV infection)
• Pregnant or breast-feeding women
• Allergic to the test sample
• Unwilling to provider personal information and sign the informed consent

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator

Study Sites (1)

Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330004, China

Location

Related Publications (6)

• Oh SY, Lee HJ, Yang HK. Pylorus-Preserving Gastrectomy for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):63-71. doi: 10.5230/jgc.2016.16.2.63. Epub 2016 Jun 24.

  PMID: 27433390 BACKGROUND

• Yang L. Incidence and mortality of gastric cancer in China. World J Gastroenterol. 2006 Jan 7;12(1):17-20. doi: 10.3748/wjg.v12.i1.17.

  PMID: 16440411 BACKGROUND

• Wu TH, Chen IC, Chen LC. Antacid effects of Chinese herbal prescriptions assessed by a modified artificial stomach model. World J Gastroenterol. 2010 Sep 21;16(35):4455-9. doi: 10.3748/wjg.v16.i35.4455.

  PMID: 20845514 BACKGROUND

• Yin GY, Chen Y, Shen XJ, He XF, Zhang WN. Study on the pathophysiologic basis of classification of 'spleen' deficiency in chronic gastritis. Chin Med J (Engl). 2005 Mar 20;118(6):468-73.

  PMID: 15788127 BACKGROUND

• Yin GY, Zhang WN, Shen XJ, He XF, Chen Y. Study on the pathological basis of classification of spleen deficiency in chronic gastritis. Chin Med J (Engl). 2004 Aug;117(8):1246-52.

  PMID: 15361303 BACKGROUND

• Zhou X, Yan DM, Zhu WF, Liu WJ, Nie HY, Xu S, Jiang YP, Zhang KH, Fu Y, Wan YY, Yu XY, Li H, Sun X, Chen XF. Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2019 Jun 10;20(1):343. doi: 10.1186/s13063-019-3429-x.

  PMID: 31182140 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Stomach Diseases

Study Officials

• Weifeng Zhu, Ph.D.

  Jiangxi University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: November 11, 2016
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)