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

Army Medical University of People's Liberation Army

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Anorexia; Cancer Cachexia

Treatments: Drug: Placebo(Megestrol Acetate); Other: Acupuncture; Other: Sham Acupuncture; Drug: Megestrol Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02619266

2015CB554504 (Other Grant/Funding Number)

2014YLC32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 3 patient groups, including a placebo group

Acupuncture+Placebo

Experimental group

Description:

Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.

Treatment:

Other: Acupuncture

Drug: Placebo(Megestrol Acetate)

Megestrol Acetate+Sham acupuncture

Active Comparator group

Description:

Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .

Treatment:

Drug: Megestrol Acetate

Other: Sham Acupuncture

Placebo+Sham acupuncture

Placebo Comparator group

Description:

Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .

Treatment:

Other: Sham Acupuncture

Drug: Placebo(Megestrol Acetate)