Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Pancreatic Cancer

Electroacupuncture Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Sham acupuncture at Baihui, Nei guan, bilateral Zu, sanli and bilateral Tian shu.

Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Electroacupuncture

Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Sham electroacupuncture

Chengfeng Wang, B.A

Evaluate the effect of perioperative electroacupuncture on rapid rehabilitation for the pancreatic cancer and periampullary carcinoma patients after operation .

The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on the clinicaltrail.gov. Quality assurance plan: every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences.

Data check: the investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 400 participants to take part in the trail.

The investigators can recruit about 200 participants every year according to previous experiences, so the investigators should recruit at least for two years. Plan for missing data: the investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of range results. Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P \< 0.05.

Perioperative Electroacupuncture After Operation

Effect of Perioperative Electroacupuncture After Operation for Pancreatic Cancer and Periampullary Carcinoma Patients: A Randomized Clinical Trial

Using scale to evaluate the function of gastrointestinal tract after surgery

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Director of Department of pancreatic and gastric Surgery Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Nausea

Vomiting

Signs and Symptoms, Digestive

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Central Nervous System Depressants

Psychotropic Drugs

Dexamethasone

Dexamethasone acetate

Olanzapine

Serotonin

Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz.

Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group. They will also receive the same antiemetic medications as the experimental group.

Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz

Participants will receive oral olanzapine at a dose of 5 mg per day on days 1 through 4, along with NK1 receptor antagonist, 5HT3 receptor antagonist, and intravenous dexamethasone at a dose of 10 mg 30 minutes prior to chemotherapy on Day 1, followed by intravenous dexamethasone at a dose of 8 mg on days 2, 3, and 4 post-chemotherapy.

Antiemetic Therapy

Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group

They will also receive the same antiemetic medications as the experimental group.

Feixue Song, Dr

This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.

This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC.

Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC on Day 1. Subsequently, participants will be randomly assigned to receive either electroacupuncture or sham acupuncture.

Participants will be responsible for recording all instances of nausea and vomiting, as well as documenting the use of rescue antiemetic medications.

The study will evaluate primary and secondary outcomes, as well as monitor adverse events.

Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study

The proportion of patients experiencing no nausea is determined by those who register a score of 0 on the visual-analogue scale for nausea throughout the entirety of treatment, spanning from initiation of chemotherapy to 120 hours post-treatment.

Feixue Song

Professor

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu

Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu

chengfeng Wang, B.A

chenefeng Wang, B.A

Evaluate the effect of Perioperative Electroacupuncture on rapid rehabilitation for the gastric cancer patients after gastrectomy .

The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on the clinicaltrail.gov. Quality assurance plan: every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences. Data check: the investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 70 participants to take part in the trail.

The investigators can recruit about 35 participants every year according to previous experiences, so the investigators should recruit at least for two years. Plan for missing data: the investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results. Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P \< 0.05.

Perioperative Electroacupuncture for Gastric Cancer Patients After Gastrectomy

Effect of Perioperative Electroacupuncture After Gastrectomy for Gastric Cancer Patients on Rapid Rehabilitation: A Randomized Clinical Trial

Using scale to evaluate the function of gastrointest after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Electroacupuncture After Operation	NCT03291561	Acupuncture Gastrointestina...	Electroacupunct... Sham electroacu...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer	NCT06314906	Electroacupunct... Olanzapine-cont... Nausea and Vomi...	Electroacupunct... Antiemetic Ther... Sham electroacu... Antiemetic Ther...	18 Years - 75 Years	The Second Hospital of Lanzhou University
Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer	NCT06314906	Electroacupunct... Olanzapine-cont... Nausea and Vomi...	Electroacupunct... Antiemetic Ther... Sham electroacu... Antiemetic Ther...	18 Years - 75 Years	The Second Hospital of Lanzhou University
Perioperative Electroacupuncture for Gastric Cancer Patients After Gastrectomy	NCT03291574	Acupuncture Gastrointestina...	Electroacupunct... Sham electroacu...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for sham electroacupuncture