Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Coagulants

All Drugs and Chemicals

Hemostatics

The acupuncture will be performed within 6 hours after surgery Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37), All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation was given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal discharge or until the fourth day.

In order to achieve maximum patient blindness, both groups will use adhesive pads, and the sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output. All study patients will be treated independently and separately to ensure that patients will not come into contact with each other.

Routine perioperative management will be given, postoperative fluid and nutritional support, correction of acid-base imbalance, electrolyte disorders, anti-infection, hemostasis and other symptomatic management.

Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation was given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal exhaust or until the fourth day.

Electroacupuncture group

Sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output.

Sham EA group

Ke Wang

Jia Zhou, M.D.

The goal of this clinical trial is to verify the efficacy of electroacupuncture in accelerating the recovery of gastrointestinal function after colorectal cancer surgery. The main questions it aims to answer are:

* Whether electroacupuncture can accelerate the recovery of gastrointestinal function in patients after colorectal cancer surgery.
* Whether electroacupuncture intervention is safe for postoperative colorectal cancer patients.

Participants will be randomized into 3 groups:

The conventional control group will receive postoperative rehydration and nutritional support, correction of acid-base imbalance and electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatments.

In the electroacupuncture group, acupuncture will be performed within 6 hours after surgery on the basis of the conventional control group. Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). Both after obtaining Qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation, the current frequency is continuous wave 5 Hz, the intensity of stimulation was as the patient tolerated, each time lasting 30 min. Acupuncture stimulation was given every 12 h. The course of treatment was terminated postoperatively until the fourth postoperative day (d0-d4) or until the patient showed the first postoperative anal exhaust or continued until the fourth day.

The sham acupuncture group will based on the conventional control group, using a blunt-tipped needle tip that do not pierce the adhesive pad.

Colorectal cancer is the most common and predominant malignancy, and radical resection surgery, as the main method of current treatment for colon and gastrointestinal cancers, is performed on a large number of patients each year. Clinically, abdominal surgery causes the highest frequency of gastrointestinal dysfunction and the longest relative duration of dysfunction. A condition in which gastrointestinal function has not fully recovered after abdominal surgery is called gastrointestinal dysfunction. The common symptoms of postoperative gastrointestinal dysmotility are abdominal distension, abdominal pain, nausea and vomiting, diminished or even absent bowel sounds, loss of anal discharge, loss of bowel movements, and even secondary symptoms such as fever and pulmonary infection. It will adversely affect patients' postoperative quality of life to varying degrees, weaken their gastrointestinal barrier capacity, and severe gastrointestinal dysfunction can lead to complications such as electrolyte disorders, intestinal adhesions, intestinal obstruction, anastomotic fistula, and abdominal wall incision dehiscence in patients, as well as increase the social burden and the economic burden of patients. Some clinical reports show that acupuncture has good efficacy on gastrointestinal dysfunction, and acupuncture has effects on the gastrointestinal tract such as promoting gastrointestinal motility and reducing the inflammatory response of the gastrointestinal tract. In this study, a multicenter, randomized, blinded, sham acupuncture-controlled clinical design will be used to verify the efficacy of postoperative electroacupuncture in accelerating the recovery of gastrointestinal function after colorectal cancer surgery.

Participants will be randomized into 3 groups:

The conventional control group will receive postoperative rehydration and nutritional support, correction of acid-base imbalance and electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatments.

In the electroacupuncture group, acupuncture will be performed within 6 hours after surgery on the basis of the conventional control group. Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). Both after obtaining Qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation, the current frequency is continuous wave 5 Hz, the intensity of stimulation was as the patient tolerated, each time lasting 30 min. Acupuncture stimulation was given every 12 h. The course of treatment was terminated postoperatively until the fourth postoperative day (d0-d4) or until the patient showed the first postoperative anal exhaust or continued until the fourth day.

The sham acupuncture group will based on the conventional control group, using a blunt-tipped needle tip that do not pierce the adhesive pad. In other words, the electroacupuncture instrument show the state of being connected, but it is not actually energized; the acupuncture points, acupuncture time points, frequency, retention time and treatment duration were the same as those of the intervention group.

Needles: Huatuo brand disposable acupuncture needles φ0.25×40mm (1.5 inch); needles are purchased from Suzhou Medical Supplies Factory Co.

Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37), lasting 30 min each time.

Postoperative electroacupuncture stimulation method: all acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation will be given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal discharge or until the fourth day.

Both groups will use adhesive pads, and the sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group.

All study patients will be treated independently and separately, ensuring that patients will not come into contact with each other. To test the effectiveness of blinding of participants, two hospitals will be selected from for blinded success assessment.

Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery

Electroacupuncture Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery: a Multicenter Randomized Controlled Study

All individual participant data that underlie results in a publication.

The time between the patient's first exhaust and the end of surgery will be recorded.

Patients self-report their defecation and doctors record the time.

Monitoring by continuous auscultation recorder of bowel sounds immediately at the end of surgery; Determination of recovery of postoperative bowel sounds: the time point when regular bowel sounds are observed and greater than 4 times/minute, calculate its time until the end of surgery (h), this outcome is only used in our center.

The time when the patient first entered water after surgery was recorded separately.

During the postoperative hospitalization, whenever nausea, vomiting and abdominal distension occur, patients or their family members use the uniform tabulation to record the occurrence time by themselves and inform the medical staff in time, and the medical staff keep records at the same time. The time until the end of the operation and the number of postoperative episodes will be calculated before discharge.

Version 3.0 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), standard score, range from 0 to 100, higher scores mean a better outcome.

Short Form 12 scale (Chinese version). (Short Form 12 scale consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability).

Visual analogy score (0 to 5, higher scores mean a worse outcome)

Calculate and record the number of days from the day of surgery to the day of patient discharge.

Hypersensitive C-reactiveprotein (hs-CRP), μg/L.

ShuGuang Hospital

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai Baoshan hospital of Integrated Traditional Chinese and Western Medicine

Shanghai Yueyang Integrated Medicine Hospital

Symptoms and General Pathology

Substance Related Disorders

Behaviors and Mental Disorders

Constipation

Opioid-Induced Constipation

Signs and Symptoms, Digestive

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Analgesics

Central Nervous System Depressants

Analgesics, Opioid

Bilateral ST25,SP14, ST37 will be used in the EA group. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal , where patients will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.

Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.

Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.

Sham electroacupuncture group

Zhishun Liu

Approximately 70-80% of patients with advanced disease will be affected by moderate to severe pain. Opioid analgesics represented by morphine and oxycodone are the cornerstone of cancer-pain management, and recommended for use in the management of moderate to severe cancer pain according to WHO Cancer Pain Relief Guidelines. One view is that a trial of systemic opioid therapy should be administered to all cancer patients with pain of moderate or greater severity regardless of the pain mechanism. Although opioids analgesics do work well as relieving pain and improving quality of life via their action at opioid receptors in the central nervous system (CNS) and the peripheral nervous system, they also have powerful adverse effects. The overall occurrence of opioid-related adverse drug events has ranged from1.8% to 13.6%. Opioid-induced constipation (OIC), one of the most prevalent adverse events (AEs) in patients receiving opioid analgesics, defined as a change in baseline bowel habits or defecatory patterns following initiation, alteration, or increase in opioid therapy. The prevalence of OIC has been estimated to affect 41% of patients with chronic noncancer pain taking opioids and 94% of cancer patients taking opioids for pain. Unlike many other opioid-related AEs, OIC is persistent and rarely tolerated. OIC impacts pain control, patients' quality of life and may cause patients to reduce the dose or discontinue opioid use.

Acupuncture, a traditional Chinese medicine, has been used to treat gastrointestinal disease including constipation for thousands of years. Two systematic reviews concluded that acupuncture can improve spontaneous bowel movements for functional constipation, and our recent study indicated that electroacupuncture(EA) could increase complete spontaneous bowel movements and is safe for chronic severe functional constipation. Acupuncture could improve gastrointestinal function via facilitating gastrointestinal motility. Currently, there is little detailed information available regarding the acupuncture use for OIC. The objective of this study is to assess the efficacy and safety of EA for OIC in patients with cancer.

Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer

Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer: Study Protocol for a Multicenter Randomized Controlled Trial

Participants will be asked to answer the following questions before the intervention: "Do you think acupuncture will be effective in treating the disease in general?" "Do you think acupuncture will be effective in improving the OIC?" and "which acupuncture modalities do you prefer, EA or SA?" For each question, patients will choose one of the following answers: "unclear/whatever", "EA", or "SA"

Five minutes after the end of any treatment in the eighth week the patients will be asked to answer the following question: "Is traditional EA the acupuncture modality that you have received?".

All adverse events (AEs) t will be recorded throughout the whole trial in case report form. AEs will be categorized as treatment-related (e.g., broken needle, dizziness, fainting, localized hematoma, localized infection or abscess, or some discomforts after acupuncture) and non-treatment-related. Detailed information regarding AEs and serious adverse events (SAEs)-including the name, onset and end date, intensity, relationship with acupuncture and outcome-will be recorded.

The mean cancerous pain intensity and worst cancerous pain intensity during the preceding week will be evaluated by 11 grades (from "0=no pain" to "10=worst pain (the strongest pain ever experienced)" at baseline, as well as weeks 2, 4, 6, 8 and 16.

The proportion of patients discontinuing the opioid, and those with increase/decrease from baseline of ≥30% opioid usage per week will be compared between groups during weeks 1-8, and weeks 9-16

A responder is defined as a patient that has at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM a week from the baseline for at least 6 of the 8 weeks of the treatment period.

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM.

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.

For stool consistency, each patient was asked to record their stool consistency according to the Bristol Stool Form Scale, on the following seven points scale. (scored from 1 to 7 for stool types 1 to 7, respectively)

For assessment of straining of SBM, each patient was asked to rate his/her score for straining using the following five-point scale: not at all difficulty (0), a little bit difficulty (1), moderately difficulty (2), quite a bit difficulty (3), extremely difficulty (4).

The PAC-SYM is a 12-item evaluative questionnaire for the chronic constipation, which consists of 4-item abdominal, 3-item rectal, and 5-item stool subscales. Each item score ranges from 0 to 4 in the 2 weeks (14 days) prior to assessment. The, where 0 = symptom absent, 1 = mild,2 = moderate,3 = severe and 4 = very severe. Lower scores indicate a lower symptom burden. Each subscale score will be calculated as the mean of the completed items for that subscale. The total score will be calculated as the mean of all completed items.

The PAC-QOL is a 28-item self-reported instrument for assessing the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. It is divided into four subscales: physical discomfort (items 1-4), psychosocial discomfort (items 5-12), worries/concerns (items 13-23), and satisfaction (items 24 to 28). Each of the item scores ranges from 0 (not at all) to 4 (extremely), with lower scores indicating a better quality of life. For each visit, individual subscale scores will be calculated as the mean of the completed items for that subscale.

each patient was asked to rate his/her efficacy of treatment using the following 7-point self-reporting scale: markedly worse (1), moderately worse (2),slightly worse (3), no change (4), slightly improved (5), moderately improved (6), markedly improved (7).

The proportion of patients using rescue medicine will be compared between groups during weeks 1-8, and weeks 9-16. The mean frequency of using rescue medicine per week during weeks 1-8 equals the total of rescue medicine consumption divided by 8. The mean frequency of using rescue medicine per week during weeks 9-16 equals the total of rescue medicine consumption divided by 8.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery	NCT06128785	Colorectal Canc... Gastrointestina...	Electroacupunct... Sham EA group	18 Years - 79 Years	Shanghai Yueyang Integrated Medicine Hospital
Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer	NCT03797586	Opioid-induced ...	Electroacupunct... Sham electroacu...	18 Years - 85 Years	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer	NCT03797586	Opioid-induced ...	Electroacupunct... Sham electroacu...	18 Years - 85 Years	Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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