Back to resultsThe Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers
Primary Purpose
Anorexia, Cancer Cachexia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Megestrol Acetate
Placebo(Megestrol Acetate)
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia focused on measuring Cancer Anorexia Cachexia Syndrome, Acupuncture, Megestrol acetate, Poor Appetite, Anorexia, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- Diagnosed gastrointestinal tand lung cancers;
- Age ≥18 years;
- Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;
- Had a history of weight loss ≥5% within 6 moths;
- Maintained oral intake;
- Signed the informed consent.
Exclusion Criteria:
- Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;
- Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;
- Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);
- Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)
- Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;
- Lifetime expected less than 3 months.
Sites / Locations
- Chongqing TCM Hospital
- XinQiao HosiptalRecruiting
- Donghua Hosiptal
- Daping HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Acupuncture+Placebo
Megestrol Acetate+Sham acupuncture
Placebo+Sham acupuncture
Arm Description
Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.
Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Outcomes
Primary Outcome Measures
Appetite Visual Analog Scale
The assessment will be done thirty minutes before meals. The participators should record the score of their appetite (0 to 100 mm) the higher scores reflect better symptom control.
Secondary Outcome Measures
Council of Nutrition appetite questionnaire (CNAQ)
Ask the subjects to complete the questionnaire by circling the correct answers and then tally the results based upon the following numerical scale: a =1, b = 2, c = 3, d = 4, e = 5. The sum of the scores for the individual items constitutes the CNAQ score. CNAQ score ≤28 indicates significant risk of at least 5% weight loss within six months.
Caloric intake
The caloric intake will be assessed by the dietician.
Functional Assessment of Anorexia/Cachexia Therapy
Functional Assessment of Anorexia/Cachexia Therapy was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns.
Nutritional status
weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined
Full Information
NCT ID
NCT02619266
First Posted
November 23, 2015
Last Updated
December 2, 2015
Sponsor
Xinqiao Hospital of Chongqing
Collaborators
Chengdu University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02619266
Brief Title
The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers
Official Title
The Traditional Chinese Medicine Department of Xin Qiao Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing
Collaborators
Chengdu University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.
Detailed Description
Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia, Cancer Cachexia
Keywords
Cancer Anorexia Cachexia Syndrome, Acupuncture, Megestrol acetate, Poor Appetite, Anorexia, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture+Placebo
Arm Type
Experimental
Arm Description
Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.
Arm Title
Megestrol Acetate+Sham acupuncture
Arm Type
Active Comparator
Arm Description
Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Arm Title
Placebo+Sham acupuncture
Arm Type
Placebo Comparator
Arm Description
Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Intervention Type
Other
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Real acupuncture, True acupuncture
Intervention Description
Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.
Intervention Type
Other
Intervention Name(s)
Sham Acupuncture
Intervention Description
Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.
Intervention Type
Drug
Intervention Name(s)
Megestrol Acetate
Other Intervention Name(s)
Positive Drug
Intervention Description
Megestrol Acetate 160mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo(Megestrol Acetate)
Other Intervention Name(s)
Placebo Pill
Intervention Description
Starch pill manufactured to mimic Megestrol Acetate 160mg tablet
Primary Outcome Measure Information:
Title
Appetite Visual Analog Scale
Description
The assessment will be done thirty minutes before meals. The participators should record the score of their appetite (0 to 100 mm) the higher scores reflect better symptom control.
Time Frame
Baseline, the days 8 and 15.
Secondary Outcome Measure Information:
Title
Council of Nutrition appetite questionnaire (CNAQ)
Description
Ask the subjects to complete the questionnaire by circling the correct answers and then tally the results based upon the following numerical scale: a =1, b = 2, c = 3, d = 4, e = 5. The sum of the scores for the individual items constitutes the CNAQ score. CNAQ score ≤28 indicates significant risk of at least 5% weight loss within six months.
Time Frame
Baseline, the days 8 and 15.
Title
Caloric intake
Description
The caloric intake will be assessed by the dietician.
Time Frame
Baseline, the days 8 and 15.
Title
Functional Assessment of Anorexia/Cachexia Therapy
Description
Functional Assessment of Anorexia/Cachexia Therapy was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns.
Time Frame
Baseline, the days 8 and 15.
Title
Nutritional status
Description
weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined
Time Frame
Baseline, the days 8 and 15.
Other Pre-specified Outcome Measures:
Title
Edmonton Symptom Assessment Scale
Description
Edmonton Symptom Assessment Scale is a nine-item patient-rated symptom visual analogue scale developed for use in assessing the symptoms of patients receiving palliative care.
Time Frame
Baseline, the days 8 and 15.
Title
The Questionnaire of Acupuncture-related Events(QAE)
Description
The side effects and their detail will be record during and after the acupuncture.
Time Frame
Baseline and the days 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed gastrointestinal tand lung cancers;
Age ≥18 years;
Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;
Had a history of weight loss ≥5% within 6 moths;
Maintained oral intake;
Signed the informed consent.
Exclusion Criteria:
Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;
Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;
Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);
Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)
Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;
Lifetime expected less than 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zihui Xu, PhD
Phone
86-023-68755615
Email
zihuixu@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Cui, MD
Phone
86-023-68774249
Email
cuiyendian@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Tang, PhD
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chaoting Zhao, MD
Organizational Affiliation
Xinqiao Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Haiou Luo, PhD
Organizational Affiliation
Xinqiao Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing TCM Hospital
City
Jiangbei
State/Province
Chongqing
ZIP/Postal Code
402760
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Li, MD
First Name & Middle Initial & Last Name & Degree
Jing Wang, MD
Facility Name
XinQiao Hosiptal
City
Shapingba
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zihui Xu, PhD
Email
zihuixu@yeah.net
First Name & Middle Initial & Last Name & Degree
Haiou Luo, MD
Facility Name
Donghua Hosiptal
City
Shapingba
State/Province
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Li, MD
Phone
86+15023101890
First Name & Middle Initial & Last Name & Degree
Dong Li, MD
Facility Name
Daping Hospital
City
Yuzhong
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinglu Shan, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23439759
Citation
Del Fabbro E, Dev R, Hui D, Palmer L, Bruera E. Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: a double-blind placebo-controlled trial. J Clin Oncol. 2013 Apr 1;31(10):1271-6. doi: 10.1200/JCO.2012.43.6766. Epub 2013 Feb 25.
Results Reference
background
PubMed Identifier
12506181
Citation
Bruera E, Strasser F, Palmer JL, Willey J, Calder K, Amyotte G, Baracos V. Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: a double-blind, placebo-controlled study. J Clin Oncol. 2003 Jan 1;21(1):129-34. doi: 10.1200/JCO.2003.01.101.
Results Reference
background
PubMed Identifier
2205358
Citation
Bruera E, Macmillan K, Kuehn N, Hanson J, MacDonald RN. A controlled trial of megestrol acetate on appetite, caloric intake, nutritional status, and other symptoms in patients with advanced cancer. Cancer. 1990 Sep 15;66(6):1279-82. doi: 10.1002/1097-0142(19900915)66:63.0.co;2-r.
Results Reference
background
Links:
URL
http://www.clinicaltrials.gov/ct2/show/NCT02148159
Description
Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer
Learn more about this trial
The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers
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