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

Phase 3UnknownNCT02619266

Xinqiao Hospital of Chongqing160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Anorexia Cancer Cachexia

Interventions

AcupunctureOTHER

Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.

Sham AcupunctureOTHER

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 AcetateDRUG

Megestrol Acetate 160mg tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Chongqing TCM Hospital

Jiangbei, Chongqing Municipality, China

NOT_YET_RECRUITING

XinQiao Hosiptal

Shapingba, Chongqing Municipality, China

RECRUITING

Donghua Hosiptal

Shapingba, Chongqing Municipality, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.