Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Nervous System Diseases

Rare Diseases

Chronic Pain

Liver Neoplasms

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Herbal and Botanical

Anesthetics

Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6), Hegu (L14), Yanglingquan (GB34), Zusanli (ST 36) and Renying (ST9) acupoints. Patients will receive 30 min TEAS before anesthesia until be discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.

Patients in the sham group will receive electrodeattachment but without stimulation.

Transcutaneous electrical acupoint stimulation (TEAS) is a contemporary modification of traditional acupuncture that sends electrical impulses into acupoints through electrodes on the skin surface. In the TEAS group, patients will receive TEAS 30 min before anesthesia until be discharged from the post-anaesthesia care unit (PACU). The same treatment will be performed on the 1st, 2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.

TEAS group

Patients in the sham group will receive electrode attachment but without stimulation.

sham group

Chunling Jiang, PhD

This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain, quality of life and survival rate in patients undergoing hepatectomy.

This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain and survival in patients undergoing hepatectomy. Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6), Hegu (L14), Yanglingquan (GB34), Zusanli (ST 36) and Renying (ST9) acupoints. Patients will receive TEAS 30 min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. Patients in the sham group will receive electrode attachment but without stimulation. Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival, overall survival at 3 months and 6 months postoperatively.

Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS group) or the sham groups using a computer-generated random number table.

Blinding of participants will be maintained throughout the observation period. The sham group will receive electrode attachment but without stimulation. Throughout the study, for adequate blinding, an opaque tape will be applied to the patient's skin above the electrodes, and the patient's target acupoints will be wrapped in a blanket. All patients will be informed that they might or might not feel a tingling sensation around the acupoints when the TEAS device is working. The patients should not be unblinded until the statistical analysis of the study data is completed.

Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy

Efficacy of Transcutaneous Electrical Acupoint Stimulation on Chronic Pain and Survival in Patients Undergoing Hepatectomy: a Prospective, Randomized Controlled Trial

Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain, 0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience.

Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating. Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain, 0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience.

Overall survival is defined as the time between the date from surgery to the date of death.

Postoperative re-examination is based on the diagnosis of enhanced CT, MRI, ultrasound or blood examination todetermine whether the patient has recurrence and metastasis. Recurrence-free time refers to the time from surgery to tumor recurrence based on the above CT, MRI, etc.

Patient self-assessment is carried out by using the World Health Organization(WHO) Disability Scale, with a minimum score of 12 points and a maximum score of 60 points. The lower the score, the higher the quality of life.

The global QoR-15 score ranges from 0 to 150 and is categorized as five quality of recovery dimensions, including physical comfort(5 items), emotional state(4 items), psychological support(2 items), physical independence(2 items), and pain(2 items). Each piece is graded using an 11-point Likert scale. The QoR is classified according to the QoR-15 score as excellent(QoR-15 \> 135), good(122 ≤ QoR-15 ≤ 135), moderate(90 ≤ QoR-15 ≤ 121) and poor(QoR-15 \<90).

Postoperative sleep quality is evaluated using the Athens Insomnia Scale(AIS). The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness. The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates adiagnosis of insomnia.

Anxiety and depression score will be evaluated using the Hospital Anxiety and Depression Scale(HADS).The HADS consists of 14 questions, with 7 items each for the anxiety and depression subscales. The score for each item ranges from 0 to 3 points, and scores are summed to yield a separate score for anxiety(HADS-A) and depression(HADS-D).

The ID Pain scale is used as a validated assessment of neuropathic pain. ID pain questionnaire consists of six items. Pain higher scores suggest a neuropathic component to the pain.

BPI pain interference subscale is a 7-item questionnaire asking participants to describe how pain has interfered general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life. Each question is answered on a scale 0(does not interfere) to 10(completely interferes). The total range of score is 0-70. The higher the scores suggest the worse the interference.

West China Hospital

Professor

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

6 week structured responsive interval exercise training programme

Negative, unsupervised, out of hospital control group

Structured responsive interval exercise training programme

NO intervention in this group, only standard care (no exercise programme)

Sham group

The present study is a randomised control trial investigating the effects of a short six week exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy prior to elective rectal cancer surgery.

Twelve patients will be randomised (1:1) to an intervention and a control group. The patients randomized to the intervention group will attend a total of 18 tailored exercise sessions (Three 40 minute sessions for six weeks) after their 6 weeks of chemoradiotherapy treatment. Where possible the exercise training sessions will be arranged to fit in with other appointments at the hospital. Patients randomized to the control group will be unsupervised. They will only attend an extra 3 sessions were a cardiopulmonary exercise test and VO2 Kinetics test will be performed. Patients will also be invited to attend 3 health related quality of life interviews at week 0, 3 and 6 during their exercise programme. These appointments will be directly before or after their exercise sessions to minimise hospital attendence.

Following surgery only routine clinically relevant observational data will be collected. These data will relate to hospital length of stay, the level of care required following surgery, post-operative morbidity survey (POMS) and the recovery process. Most of this information can be accessed from patient notes and on the electronic patient records system.

This is a subgroup RCT of patients in a larger interventional trial (6 control and 6 exercise intervention patients) will be asked to consent separately for the the 31-Phosphorus Magnetic Resonance Spectroscopy (31P MRS) scans and the blood samples.

HYPOTHESIS

1. Interval exercise training will maintain or improve fitness (measured by anaerobic threshold) in patients undergoing neoadjuvant chemoradiotherapy.
2. Interval exercise training is safe and feasible in patients undergoing neoadjuvant chemoradiotherapy awaiting rectal cancer resection.
3. Interval exercise training will improve other measures of physical fitness measured in the CPET and the oxygen uptake kinetics test.
4. Interval exercise training will improve quality of life in patients undergoing neoadjuvant chemoradiotherapy.
5. Improvements in physical fitness will reduce postoperative complications following major rectal cancer surgery.
6. Does physical activity, measured by Sensewear Pro 3 activity monitors, decrease during neoadjuvant chemoradiotherapy and can this decrease be attenuated by an exercise training program?
7. Can we find an optimal time for surgery when fitness and cancer downstaging are at their best?

HYPOTHESIS for Mechanism Pilot Study

1. To explore the exponential rate constant of post-exercise phosphocreatine recovery.
2. To explore the alteration in cellular and mitochondrial energetics eg. Change in mitochondrial numbers, change in mitochondrial activity and respiration.

All patients will attend 5 sets of appointments at the hospital for diagnostic tests and 3 appointments at the University of Liverpool Magnetic Resonance and Image Analysis Research Centre (MARIARC). Three appointments will be prior to chemoradiotherapy treatment, and the other 4 will be after chemoradiotherapy. Two of these 5 appointments are part of routine care. The first 4 appointments will last about an hour. Patients will complete 3 quality of life questionnaires on recruitment, during chemotherapy, before and 4-6 weeks after surgery. These 3 questionnaires will take 20 minutes to fill in. The fourth and fifth appointments will consist of Computed Tomogram (CT) and Magnetic Resonance Imaging (MRI) scans in our radiology department to assess cancer staging. These appointments will last about 1 hour 30 minutes.

The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness

Phase 1 Study of Mitochondrial Energetics After Long Course Chemoradiotherapy and a Short Term Exercise Programme in Locally Advanced Rectal Cancer Patients - A Randomized Controlled Trial.

Changes in 31- Phosphoromagnetic resonance spectroscopic (31-PMRS) ATP:ADP ratio

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy	NCT06406244	Liver Cancer	TEAS group sham group	18 Years - 80 Years	West China Hospital
Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy	NCT06406244	Liver Cancer	TEAS group sham group	18 Years - 80 Years	West China Hospital
The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness	NCT01859442	Locally Advance...	Structured resp... Sham group	18 Years -	Liverpool University Hospitals NHS Foundation Trust
The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness	NCT01859442	Locally Advance...	Structured resp... Sham group	18 Years -	Liverpool University Hospitals NHS Foundation Trust

Spots Global Cancer Trial Database for sham group

Every month we try and update this database with for sham group cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sham group

Every month we try and update this database with for sham group cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sham group cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.