Clinical trial NCT02619266: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Anorexia
Cancer Cachexia
Keywords: Cancer Anorexia Cachexia Syndrome
Acupuncture
Megestrol acetate
Poor Appetite
Anorexia
Randomized Controlled Trial
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: Chengdu University of Traditional Chinese Medicine
First posted: 2015-12-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Appetite Visual Analog Scale
timeFrame: Baseline, the days 8 and 15.
Secondary outcomes:
measure: Council of Nutrition appetite questionnaire (CNAQ)
timeFrame: Baseline, the days 8 and 15.
measure: Caloric intake
timeFrame: Baseline, the days 8 and 15.
measure: Functional Assessment of Anorexia/Cachexia Therapy
timeFrame: Baseline, the days 8 and 15.
measure: Nutritional status
timeFrame: Baseline, the days 8 and 15.
Other outcomes:
measure: Edmonton Symptom Assessment Scale
timeFrame: Baseline, the days 8 and 15.
measure: The Questionnaire of Acupuncture-related Events(QAE)
timeFrame: Baseline and the days 7
Locations:
city: Jiangbei
country: China
facility: Chongqing TCM Hospital
state: Chongqing
city: Shapingba
country: China
facility: XinQiao Hosiptal
state: Chongqing
city: Shapingba
country: China
facility: Donghua Hosiptal
state: Chongqing
city: Yuzhong
country: China
facility: Daping Hospital
state: Chongqing
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Yong Tang, PhD
role: STUDY_CHAIR
affiliation: Xinqiao Hospital
name: Chaoting Zhao, MD
role: STUDY_DIRECTOR
affiliation: Xinqiao Hospital
name: Haiou Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.