Resectable Colorectal CarcinomaNCT04560712
Acupuncture for the Management of Postoperative Pain in Patients With Pancreatic or Colorectal Cancer Undergoing Surgery
A study testing Acupuncture Therapy, Best Practice and Questionnaire Administration in people with Resectable Colorectal Carcinoma and Resectable Digestive System Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Colorectal Carcinoma, Resectable Digestive System Carcinoma, Resectable Pancreatic Carcinoma
- What is being tested?
- Acupuncture Therapy, Best Practice and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Undergoing open gastrointestinal cancer resection (pancreatic or colorectal)
- Must understand and read English
- Sign a written informed consent and willing to follow protocol requirements
- Able to consent to treatment
Who cannot join
- Chronic opioid use > 90 mg MME (morphine milligram equivalents) for more than 7 days
- Mechanical bowel obstruction
- Active seizure activity after admission
- Compromised cognitive function per referring physician and/or inability to cooperate with acupuncture procedure
- Direct admission to intensive care unit after operation will result in removal from protocol
- Prior intra-abdominal operation in the past 6 months
- Any contraindications to acupuncture including infections or inability to access acupoint sites
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations
This trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects and improves recovery.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility of providing postoperative acupuncture for patients undergoing open colorectal or pancreatic surgery.
SECONDARY OBJECTIVE:
- Compare postoperative opioid use for pain management, pain levels, and satisfaction of pain control between acupuncture and standard care groups.
EXPLORATORY OBJECTIVE:
- Compare dietary recovery and postoperative length of stay between acupuncture and standard care groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ACUPUNCTURE): Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes once daily (QD) for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
ARM II (USUAL CARE): Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
- Conditions
- Resectable Colorectal Carcinoma, Resectable Digestive System Carcinoma, Resectable Pancreatic Carcinoma
- Being tested
- Acupuncture Therapy, Best Practice, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture TherapyProcedure or surgery
Also called Acupuncture
Undergo acupuncture
Best PracticeOther
Also called standard of care, standard therapy
Undergo usual care
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (acupuncture, usual care) | Experimental | Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes QD for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits. Receives: Procedure: Acupuncture Therapy; Other: Best Practice; Other: Questionnaire Administration |
| Arm II (usual care) | Active comparator | Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate to daily acupuncture
Acupuncturist will document in the medical record all the treatments participants are completing and also document if missing any treatments.
Measured: Up to 7 days
Compliance
Acupuncturist and research coordinator will document in EPIC if participant is compliant with acupuncture sessions (study intervention) and with study questionnaires.
Measured: Up to 7 days
Retention
Will be measured as percentage of patients who complete the study out of the number of patients after study randomization.
Measured: Up to 7 days
Secondary outcomes (3)
Postoperative opioid use for pain management
Will be compared between acupuncture and standard care groups. Will estimate the mean difference and 95% confidence interval (CI). Secondary analyses will be performed using analysis of covariance by adjusting for the postoperative opioid requirement for the first 24 hours (and/or other relevant patient characteristics).
Measured: 24 hours
Pain levels
Pain will be measured by the MD Anderson Symptom Inventory (MDASI) core symptoms to obatain data on satisfaction of pain control and other symptom mamgement starting on PDO1 and then every other day until discharge
Measured: Up to 7 days
Satisfaction of pain control
The satisfaction of pain control will be assessed using the MD Anderson Symptom Inventory (MDASI). The MDASI consists of a core list of symptoms that are common across all cancer diagnoses and treatments [15]. Participants will rate the intensity of physical, affective, and cognitive symptoms on a 0 to 10 numeric scale from "not present" to "as bad as you can imagine." Participants will also rate the amount of interference with daily activities caused by symptoms on a 0 to 10 numeric scale from "did not interfere" to "interfere completely"
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start12 Aug 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560712
- Sponsor's protocol ID
- 2020-0234
- Other IDs
- NCI-2020-05225, 2020-0234
- Status last verified
- Jun 2026
- First submitted
- 27 Jul 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations
- ClinicalTrials.gov ID
- NCT04560712
- Acronym / sponsor ID
- 2020-0234
- Conditions
- Resectable Colorectal Carcinoma, Resectable Digestive System Carcinoma, Resectable Pancreatic Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Sep 2020 (actual)
- 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 trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects and improves recovery.
Detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility of providing postoperative acupuncture for patients undergoing open colorectal or pancreatic surgery.
SECONDARY OBJECTIVE:
- Compare postoperative opioid use for pain management, pain levels, and satisfaction of pain control between acupuncture and standard care groups.
EXPLORATORY OBJECTIVE:
- Compare dietary recovery and postoperative length of stay between acupuncture and standard care groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ACUPUNCTURE): Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes once daily (QD) for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
ARM II (USUAL CARE): Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (acupuncture, usual care) | Experimental | Procedure: Acupuncture Therapy, Other: Best Practice, Other: Questionnaire AdministrationBeginning the day after surgery, patients undergo acupuncture sessions over 25 minutes QD for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits. |
| Arm II (usual care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing open gastrointestinal cancer resection (pancreatic or colorectal)
- Must understand and read English
- Sign a written informed consent and willing to follow protocol requirements
- Able to consent to treatment
Key exclusion criteria (7 listed)
- Chronic opioid use > 90 mg MME (morphine milligram equivalents) for more than 7 days
- Mechanical bowel obstruction
- Active seizure activity after admission
- Compromised cognitive function per referring physician and/or inability to cooperate with acupuncture procedure
- Direct admission to intensive care unit after operation will result in removal from protocol
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 |
|---|---|---|
| Acupuncture TherapyAlso: AcupunctureUndergo acupuncture | Procedure or surgery | Arm I (acupuncture, usual care) |
| Best PracticeAlso: standard of care, standard therapyUndergo usual care | Other | Arm I (acupuncture, usual care), Arm II (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (acupuncture, usual care), Arm II (usual care) |
Primary outcome
Adherence rate to daily acupuncture
Time frame: Up to 7 days
Acupuncturist will document in the medical record all the treatments participants are completing and also document if missing any treatments.
Compliance
Time frame: Up to 7 days
Acupuncturist and research coordinator will document in EPIC if participant is compliant with acupuncture sessions (study intervention) and with study questionnaires.
Retention
Time frame: Up to 7 days
Will be measured as percentage of patients who complete the study out of the number of patients after study randomization.
3 secondary outcomes
Postoperative opioid use for pain management
Time frame: 24 hours
Pain levels
Time frame: Up to 7 days
Satisfaction of pain control
Time frame: Up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- http://www.mdanderson.orgLink 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.
Lorenzo Cohen principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Therapy, Best Practice and Questionnaire Administration in people with Resectable Colorectal Carcinoma and Resectable Digestive System Carcinoma, run by M.D. Anderson Cancer Center 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adherence rate to daily acupuncture (time frame: Up to 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.