Malignant Neoplasm of Gastrointestinal TractNCT02148159
Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer
A study testing Cachexia Acupuncture-A (Peace Classic Needles® ) and General Acupuncture-B (Peace Classic Needles®) in people with Malignant Neoplasm of Gastrointestinal Tract, run by University of Florida at 1 site in United States.
Trial summary
Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Malignant Neoplasm of Gastrointestinal Tract
- What is being tested?
- Cachexia Acupuncture-A (Peace Classic Needles® ) and General Acupuncture-B (Peace Classic Needles®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2016
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 year or older
- medical diagnosis of gastrointestinal cancer (for example, gastric, biliary, or colorectal)
- experienced weight loss of at least 5% over the last 6 months
- ability to communicate in English
- ability to follow the research protocol
Who cannot join
- plan to have surgical procedures at the time of recruitment
- receive radiation therapy alone or in addition to chemotherapy during the study period
- undergo surgery during the study or in the months prior to the study
- no plan to have chemotherapy after the surgery
- any comorbidities that may affect the interpretation of study findings
- open burn sites or infected wounds
- esophageal cancer or pancreatic cancer
- life expectancy of less than 6 months as assessed by attending physician
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Clinical Research Center (CRC)
Gainesville, Florida, 32610-0219
About this study
Official title: Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia
Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. An intervention with acupuncture may slow down or stop the progression of cancer-related anorexia and weight loss.
Read the detailed description
The purpose of this research study is to investigate if acupuncture helps to improve appetite and slow down unintentional weight loss. The participants will be randomly divided into two groups and receive 8 sessions of acupuncture (two groups will receive different acupuncture points) for 8 weeks. During the study period, participants will be asked various questions about appetite, physical functioning, cancer-related symptoms and quality of life to understand changes related to body weight, as well as blood samples. The research team members will collect data regarding changes in appetite, body weight, body composition, and physical functioning.
- Being tested
- Cachexia Acupuncture-A (Peace Classic Needles® ), General Acupuncture-B (Peace Classic Needles®)
- Keywords
- anorexia, cachexia, cancer, unintentional weigh loss, gastrointestinal tract, adults
- Medical subject headings
- Gastrointestinal Neoplasms, Anorexia, Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cachexia Acupuncture-A (Peace Classic Needles® )Device
Also called Acu-Market, Mechanism based acupuncture
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
General Acupuncture-B (Peace Classic Needles®)Device
Also called Acu-Market, General acupuncture
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
| Study group | Role | What they receive |
|---|---|---|
| Cachexia Acupuncture-A | Experimental | Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points that are selected based on the potential mechanisms of cachexia. Intervention will be done by a licensed acupuncturist who has over 5 years of experience as an independent clinician and has experience particularly in the management of cancer related symptoms. Acupuncture treatment will consist of 8 sessions over 8 week period.
Acupuncture needles: Single-use, sterile stainless steel and disposable [acupuncture needles-Peace Classic Needles®, Acu-Market] Other name: Mechanism based acupuncture Receives: Device: Cachexia Acupuncture-A (Peace Classic Needles® ) |
| General Acupuncture-B | Sham comparator | General Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points. These points are the real acupuncture points; however, these points are not specific to cachexia management. Participants will receive the acupuncture treatment over 8 weeks (total of 8 sessions) in the same manner as the experimental group; the only difference will be the place(type) and number of points targeted.
Acupuncture needles: single-use, sterile stainless steel and disposable needles [Peace Classic Needles®, Acu-Market] Other name: General acupuncture Receives: Device: General Acupuncture-B (Peace Classic Needles®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage weight change over 8 weeks between two arms
Weight will be measured each visit (pounds).
Measured: up to 8 weeks
Secondary outcomes (3)
Appetite change between two arms
Three different short survey forms will be used to measure appetite change. Visual analogue scale (0 indicates no appetite and 10 is the best appetite). Simplified Nutritional Appetite Questionnaire score (min-max: 4-20 and the higher the better appetite) Patient Generated Subjective Global Assessment: 0-1, no intervention is needed. 9 or higher score indicates critical intervention.
Measured: up to 8 weeks
physical functioning
survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).
Measured: up to 8 weeks
body composition
Small, non-invasive device (bioelectrical impedance analysis) like a miniature version of EKG will measure changes in body composition (numeric scale).
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of Gastrointestinal TractStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saunjoo Yoon, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148159
- Sponsor's protocol ID
- IRB201400340
- Other IDs
- OCR14647
- Status last verified
- Jan 2019
- First submitted
- 15 May 2014
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon SL, Grundmann O, Williams JJ, Gordan L, George TJ Jr. Body composition changes differ by gender in stomach, colorectal, and biliary cancer patients with cachexia: Results from a pilot study. Cancer Med. 2018 Aug;7(8):3695-3703. doi: 10.1002/cam4.1665. Epub 2018 Jul 3.
PubMed 29971962
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia
- ClinicalTrials.gov ID
- NCT02148159
- Acronym / sponsor ID
- IRB201400340
- Keywords
- anorexia, cachexia, cancer, unintentional weigh loss, gastrointestinal tract, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 May 2014 (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.
Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. An intervention with acupuncture may slow down or stop the progression of cancer-related anorexia and weight loss.
Detailed description
The purpose of this research study is to investigate if acupuncture helps to improve appetite and slow down unintentional weight loss. The participants will be randomly divided into two groups and receive 8 sessions of acupuncture (two groups will receive different acupuncture points) for 8 weeks. During the study period, participants will be asked various questions about appetite, physical functioning, cancer-related symptoms and quality of life to understand changes related to body weight, as well as blood samples. The research team members will collect data regarding changes in appetite, body weight, body composition, and physical functioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cachexia Acupuncture-A | Experimental | Device: Cachexia Acupuncture-A (Peace Classic Needles® )Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points that are selected based on the potential mechanisms of cachexia. Intervention will be done by a licensed acupuncturist who has over 5 years of experience as an independent clinician and has experience particularly in the management of cancer related symptoms. Acupuncture treatment will consist of 8 sessions over 8 week period. Acupuncture needles: Single-use, sterile stainless steel and disposable [acupuncture needles-Peace Classic Needles®, Acu-Market] Other name: Mechanism based acupuncture |
| General Acupuncture-B | Sham comparator | Device: General Acupuncture-B (Peace Classic Needles®)General Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points. These points are the real acupuncture points; however, these points are not specific to cachexia management. Participants will receive the acupuncture treatment over 8 weeks (total of 8 sessions) in the same manner as the experimental group; the only difference will be the place(type) and number of points targeted. Acupuncture needles: single-use, sterile stainless steel and disposable needles [Peace Classic Needles®, Acu-Market] Other name: General acupuncture |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 year or older
- medical diagnosis of gastrointestinal cancer (for example, gastric, biliary, or colorectal)
- experienced weight loss of at least 5% over the last 6 months
- ability to communicate in English
- ability to follow the research protocol
Key exclusion criteria (8 listed)
- plan to have surgical procedures at the time of recruitment
- receive radiation therapy alone or in addition to chemotherapy during the study period
- undergo surgery during the study or in the months prior to the study
- no plan to have chemotherapy after the surgery
- any comorbidities that may affect the interpretation of study findings
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 |
|---|---|---|
| Cachexia Acupuncture-A (Peace Classic Needles® )Also: Acu-Market, Mechanism based acupunctureAcupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points. | Device | Cachexia Acupuncture-A |
| General Acupuncture-B (Peace Classic Needles®)Also: Acu-Market, General acupunctureAcupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points. | Device | General Acupuncture-B |
Primary outcome
Percentage weight change over 8 weeks between two arms
Time frame: up to 8 weeks
Weight will be measured each visit (pounds).
3 secondary outcomes
Appetite change between two arms
Time frame: up to 8 weeks
physical functioning
Time frame: up to 8 weeks
body composition
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Derived from this study: PubMed 29971962Yoon SL, Grundmann O, Williams JJ, Gordan L, George TJ Jr. Body composition changes differ by gender in stomach, colorectal, and biliary cancer patients with cachexia: Results from a pilot study. Cancer Med. 2018 Aug;7(8):3695-3703. doi: 10.1002/cam4.1665. Epub 2018 Jul 3.
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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.
Saunjoo Yoon, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cachexia Acupuncture-A (Peace Classic Needles® ) and General Acupuncture-B (Peace Classic Needles®) in people with Malignant Neoplasm of Gastrointestinal Tract, run by University of Florida at 1 site in United States.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage weight change over 8 weeks between two arms (time frame: up to 8 weeks). 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 NCT02148159, which also lists 1 linked publication.
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 17 Jan 2019.