AnorexiaPhase 2/3NCT02619266
The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers
A Phase 2/3 study testing Acupuncture and Megestrol Acetate in people with Anorexia and Cancer Cachexia, run by Xinqiao Hospital of Chongqing at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia, Cancer Cachexia
- What is being tested?
- Acupuncture and Megestrol Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2015to Feb 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed gastrointestinal tand lung cancers;
- Age ≥18 years;
- Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;
- Had a history of weight loss ≥5% within 6 moths;
- Maintained oral intake;
- Signed the informed consent.
Who cannot join
- Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;
- Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;
- Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);
- Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)
- Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;
- Lifetime expected less than 3 months.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
Chongqing TCM Hospital
Jiangbei, Chongqing Municipality, 402760
Jian Li, MD
Jing Wang, MD
- Recruiting
XinQiao Hosiptal
Shapingba, Chongqing Municipality, 400037
Zihui Xu, PhD, zihuixu@yeah.net
Haiou Luo, MD
- Not yet recruiting
Donghua Hosiptal
Shapingba, Chongqing Municipality
Dong Li, MD, 86+15023101890
Dong Li, MD
- Recruiting
Daping Hospital
Yuzhong, Chongqing Municipality, 400042
Jinglu Shan, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia, Cancer Cachexia
- Being tested
- Acupuncture, Sham Acupuncture, Megestrol Acetate, Placebo(Megestrol Acetate)
- Keywords
- Cancer Anorexia Cachexia Syndrome, Acupuncture, Megestrol acetate, Poor Appetite, Anorexia, Randomized Controlled Trial
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Real acupuncture, True acupuncture
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
Also called Positive Drug
Megestrol Acetate 160mg tablet
Placebo(Megestrol Acetate)Drug
Also called Placebo Pill
Starch pill manufactured to mimic Megestrol Acetate 160mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture+Placebo | Experimental | Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days. Receives: Other: Acupuncture; Drug: Placebo(Megestrol Acetate) |
| Megestrol Acetate+Sham acupuncture | Active comparator | Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days . Receives: Other: Sham Acupuncture; Drug: Megestrol Acetate |
| Placebo+Sham acupuncture | Placebo comparator | Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days . Receives: Other: Sham Acupuncture; Drug: Placebo(Megestrol Acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, the days 8 and 15.
Secondary outcomes (4)
Council of Nutrition appetite questionnaire (CNAQ)
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.
Measured: Baseline, the days 8 and 15.
Caloric intake
The caloric intake will be assessed by the dietician.
Measured: Baseline, the days 8 and 15.
Functional Assessment of Anorexia/Cachexia Therapy
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.
Measured: Baseline, the days 8 and 15.
Nutritional status
weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined
Measured: Baseline, the days 8 and 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Chaoting Zhao, Xinqiao Hospital of Chongqing
- Investigators
- Yong Tang, PhD, Study chair, Chengdu University of Traditional Chinese MedicineChaoting Zhao, MD, Study director, Xinqiao HospitalHaiou Luo, PhD, Principal investigator, Xinqiao Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619266
- Sponsor's protocol ID
- 2014YLC32
- Other IDs
- 2015CB554504
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2015
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23439759Bruera 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.
PubMed 12506181Bruera 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.
PubMed 2205358
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Traditional Chinese Medicine Department of Xin Qiao Hospital
- ClinicalTrials.gov ID
- NCT02619266
- Acronym / sponsor ID
- 2014YLC32
- Conditions
- Anorexia, Cancer Cachexia
- Keywords
- Cancer Anorexia Cachexia Syndrome, Acupuncture, Megestrol acetate, Poor Appetite, Anorexia, Randomized Controlled Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture+Placebo | Experimental | Other: Acupuncture, Drug: Placebo(Megestrol Acetate)Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days. |
| Megestrol Acetate+Sham acupuncture | Active comparator | Other: Sham Acupuncture, Drug: Megestrol AcetateMegestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days . |
| Placebo+Sham acupuncture | Placebo comparator | Other: Sham Acupuncture, Drug: Placebo(Megestrol Acetate)Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed gastrointestinal tand lung cancers;
- Age ≥18 years;
- Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;
- Had a history of weight loss ≥5% within 6 moths;
- Maintained oral intake;
Key exclusion criteria (6 listed)
- Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;
- Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;
- Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);
- Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)
- Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Real acupuncture, True acupunctureAcupuncture is the practice of inserting thin needles into specific points to improve health and well-being. | Other | Acupuncture+Placebo |
| Sham AcupunctureSham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders. | Other | Megestrol Acetate+Sham acupuncture, Placebo+Sham acupuncture |
| Megestrol AcetateAlso: Positive DrugMegestrol Acetate 160mg tablet | Drug | Megestrol Acetate+Sham acupuncture |
| Placebo(Megestrol Acetate)Also: Placebo PillStarch pill manufactured to mimic Megestrol Acetate 160mg tablet | Drug | Acupuncture+Placebo, Placebo+Sham acupuncture |
Primary outcome
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.
4 secondary outcomes
Council of Nutrition appetite questionnaire (CNAQ)
Time frame: Baseline, the days 8 and 15.
Caloric intake
Time frame: Baseline, the days 8 and 15.
Functional Assessment of Anorexia/Cachexia Therapy
Time frame: Baseline, the days 8 and 15.
Nutritional status
Time frame: Baseline, the days 8 and 15.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Background: PubMed 23439759Del 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.
- Background: PubMed 12506181Bruera 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.
- Background: PubMed 2205358Bruera 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.
- Acupuncture for Unintentional Weight Loss and Anorexia With GI CancerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Tang, PhD study chair
Chengdu University of Traditional Chinese Medicine
Chaoting Zhao, MD study director
Xinqiao Hospital
Haiou Luo, PhD principal investigator
Xinqiao Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acupuncture and Megestrol Acetate in people with Anorexia and Cancer Cachexia, run by Xinqiao Hospital of Chongqing at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zihui Xu, PhD (86-023-68755615, zihuixu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite Visual Analog Scale (time frame: Baseline, the days 8 and 15.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619266, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.