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

NCT ID: NCT02619266

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anorexia Cancer Cachexia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acupuncture+Placebo

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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

Placebo(Megestrol Acetate)

Intervention Type DRUG

Starch pill manufactured to mimic Megestrol Acetate 160mg tablet

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 .

Group Type ACTIVE_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

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 Acetate

Intervention Type DRUG

Megestrol Acetate 160mg tablet

Placebo+Sham acupuncture

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

Group Type PLACEBO_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.

Placebo(Megestrol Acetate)

Intervention Type DRUG

Starch pill manufactured to mimic Megestrol Acetate 160mg tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acupuncture

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

Intervention Type 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.

Intervention Type OTHER

Megestrol Acetate

Megestrol Acetate 160mg tablet

Intervention Type DRUG

Placebo(Megestrol Acetate)

Starch pill manufactured to mimic Megestrol Acetate 160mg tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Real acupuncture True acupuncture Positive Drug Placebo Pill

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chaoting Zhao

Vice Director, Clinical Reseach

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yong Tang, PhD

Role: STUDY_CHAIR

Chengdu University of Traditional Chinese Medicine

Chaoting Zhao, MD

Role: STUDY_DIRECTOR

Xinqiao Hospital

Haiou Luo, PhD

Role: PRINCIPAL_INVESTIGATOR

Xinqiao Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chongqing TCM Hospital

Jiangbei, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

XinQiao Hosiptal

Shapingba, Chongqing Municipality, China

Site Status RECRUITING

Donghua Hosiptal

Shapingba, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

Daping Hospital

Yuzhong, Chongqing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zihui Xu, PhD

Role: CONTACT

86-023-68755615

Ye Cui, MD

Role: CONTACT

86-023-68774249

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jian Li, MD

Role: primary

Zihui Xu, PhD

Role: primary

Dong Li, MD

Role: primary

86+15023101890

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23439759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12506181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2205358 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.clinicaltrials.gov/ct2/show/NCT02148159

Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015CB554504

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2014YLC32

Identifier Type: -

Identifier Source: org_study_id