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

December 2, 2015 updated by: Chaoting Zhao, Xinqiao Hospital of Chongqing

The Traditional Chinese Medicine Department of Xin Qiao Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Jiangbei, Chongqing, China, 402760
        • Not yet recruiting
        • Chongqing TCM Hospital
        • Principal Investigator:
          • Jing Wang, MD
        • Contact:
          • Jian Li, MD
      • Shapingba, Chongqing, China, 400037
        • Recruiting
        • XinQiao Hosiptal
        • Contact:
        • Principal Investigator:
          • Haiou Luo, MD
      • Shapingba, Chongqing, China
        • Not yet recruiting
        • Donghua Hosiptal
        • Contact:
          • Dong Li, MD
          • Phone Number: 86+15023101890
        • Principal Investigator:
          • Dong Li, MD
      • Yuzhong, Chongqing, China, 400042
        • Recruiting
        • Daping Hospital
        • Principal Investigator:
          • Jinglu Shan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture+Placebo
Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.
Other: Acupuncture
Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.
Other Names:
  • Real acupuncture
  • True acupuncture
Drug: Placebo(Megestrol Acetate)
Starch pill manufactured to mimic Megestrol Acetate 160mg tablet
Other Names:
  • Placebo Pill
Active Comparator: Megestrol Acetate+Sham acupuncture
Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Other: 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
Other Names:
  • Positive Drug
Placebo Comparator: Placebo+Sham acupuncture
Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
Drug: Placebo(Megestrol Acetate)
Starch pill manufactured to mimic Megestrol Acetate 160mg tablet
Other Names:
  • Placebo Pill
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite Visual Analog Scale
Time Frame: Baseline, the days 8 and 15.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Council of Nutrition appetite questionnaire (CNAQ)
Time Frame: Baseline, the days 8 and 15.
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.
Caloric intake
Time Frame: Baseline, the days 8 and 15.
The caloric intake will be assessed by the dietician.
Baseline, the days 8 and 15.
Functional Assessment of Anorexia/Cachexia Therapy
Time Frame: Baseline, the days 8 and 15.
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.
Nutritional status
Time Frame: Baseline, the days 8 and 15.
weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined
Baseline, the days 8 and 15.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edmonton Symptom Assessment Scale
Time Frame: Baseline, the days 8 and 15.
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.
The Questionnaire of Acupuncture-related Events(QAE)
Time Frame: Baseline and the days 7
The side effects and their detail will be record during and after the acupuncture.
Baseline and the days 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinqiao Hospital of Chongqing

Collaborators

Chengdu University of Traditional Chinese Medicine

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014YLC32
  • 2015CB554504 (Other Grant/Funding Number: National Program on Key Basic Research Project (973 Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anorexia

Clinical Trials on Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe