The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers

Anorexia Clinical Trial

Official title:

The Traditional Chinese Medicine Department of Xin Qiao Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02619266
• Other study ID #: 2014YLC32
• Secondary ID: 2015CB554504
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 23, 2015
• Last updated: December 2, 2015
• Start date: December 2015
• Est. completion date: February 2017

Study information

• Verified date: December 2015
• Source: Xinqiao Hospital of Chongqing
• Contact: Zihui Xu, PhD
• Phone: 86—023—68755615
• Email: zihuixu[@]yeah.net
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed gastrointestinal tand lung cancers;

2. Age =18 years;

3. Appetite score= 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;

4. Had a history of weight loss =5% within 6 moths;

5. Maintained oral intake;

6. Signed the informed consent.

Exclusion Criteria:

1. Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;

2. Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms= 3, 0= worst) ;

3. Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);

4. Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)

5. Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;

6. Lifetime expected less than 3 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Cachexia
• Cancer Cachexia

Intervention

Other:
• Acupuncture
Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.
• Sham Acupuncture
Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.

Drug:
• Megestrol Acetate
Megestrol Acetate 160mg tablet
• Placebo(Megestrol Acetate)
Starch pill manufactured to mimic Megestrol Acetate 160mg tablet

Locations

Country	Name	City	State
China	Chongqing TCM Hospital	Jiangbei	Chongqing
China	Donghua Hosiptal	Shapingba	Chongqing
China	XinQiao Hosiptal	Shapingba	Chongqing
China	Daping Hospital	Yuzhong	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing	Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edmonton Symptom Assessment Scale	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.	Baseline, the days 8 and 15.	No
Other	The Questionnaire of Acupuncture—related Events(QAE)	The side effects and their detail will be record during and after the acupuncture.	Baseline and the days 7	Yes
Primary	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.	No
Secondary	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.	Baseline, the days 8 and 15.	No
Secondary	Caloric intake	The caloric intake will be assessed by the dietician.	Baseline, the days 8 and 15.	No
Secondary	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.	Baseline, the days 8 and 15.	No
Secondary	Nutritional status	weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined	Baseline, the days 8 and 15.	No

External Links

•   Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer