The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers
The Traditional Chinese Medicine Department of Xin Qiao Hospital
2 other identifiers
interventional
160
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2015
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedDecember 4, 2015
December 1, 2015
1 year
November 23, 2015
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, the days 8 and 15.
Secondary Outcomes (4)
Council of Nutrition appetite questionnaire (CNAQ)
Baseline, the days 8 and 15.
Caloric intake
Baseline, the days 8 and 15.
Functional Assessment of Anorexia/Cachexia Therapy
Baseline, the days 8 and 15.
Nutritional status
Baseline, the days 8 and 15.
Other Outcomes (2)
Edmonton Symptom Assessment Scale
Baseline, the days 8 and 15.
The Questionnaire of Acupuncture-related Events(QAE)
Baseline and the days 7
Study Arms (3)
Acupuncture+Placebo
EXPERIMENTALAcupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.
Megestrol Acetate+Sham acupuncture
ACTIVE COMPARATORMegestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Placebo+Sham acupuncture
PLACEBO COMPARATORPlacebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Interventions
Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.
Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.
Megestrol Acetate 160mg tablet
Starch pill manufactured to mimic Megestrol Acetate 160mg tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Chongqing TCM Hospital
Jiangbei, Chongqing Municipality, 402760, China
XinQiao Hosiptal
Shapingba, Chongqing Municipality, 400037, China
Donghua Hosiptal
Shapingba, Chongqing Municipality, China
Daping Hospital
Yuzhong, Chongqing Municipality, 400042, China
Related Publications (3)
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.
PMID: 23439759BACKGROUNDBruera 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.
PMID: 12506181BACKGROUNDBruera 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.
PMID: 2205358BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yong Tang, PhD
Chengdu University of Traditional Chinese Medicine
- STUDY DIRECTOR
Chaoting Zhao, MD
Xinqiao Hospital
- PRINCIPAL INVESTIGATOR
Haiou Luo, PhD
Xinqiao Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director, Clinical Reseach
Study Record Dates
First Submitted
November 23, 2015
First Posted
December 2, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
December 4, 2015
Record last verified: 2015-12