The effect of acupuncture in the prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer
| ISRCTN | ISRCTN13287728 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13287728 |
| ClinicalTrials.gov number | NCT02369107 |
| Secondary identifying numbers | XM201410 |
- Submission date
- 27/11/2014
- Registration date
- 28/02/2015
- Last edited
- 06/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Nausea and vomiting are the most common symptoms experienced by patients with cancer after chemotherapy. Some patients in chemotherapy still have the symptoms even with common use of antiemetic ( anti-vomiting) drugs. The aim of this study is to assess the effects and safety of acupuncture for chemotherapy-induced nausea and vomiting in patients with advanced cancer.
Who can participate?
Patients aged 18-75 with lung cancer, breast cancer or gynecological cancer
What does the study involve?
Participants are randomly allocated to one of two groups: the intervention group or the control group. Participants in the intervention group receive acupuncture therapy 6 times in 5 days. Participants in the control group receive minimal acupuncture therapy 6 times in 5 days. They complete questionnaires at the start of the study and during the study to find out about any changes in the severity of nausea and vomiting, sleep, appetite and emotion. They are followed up for 3 weeks to assess long-term effectiveness.
What are the possible benefits and risks of participating?
All participants receive free treatment for 5 days and a series of free examinations. The symptoms of nausea and vomiting could be relieved. The results of this study may help to provide evidence that acupuncture is effective for managing chemotherapy-induced nausea and vomiting. The risks of taking part are minimal. Acupuncture is a very safe treatment when given by properly trained clinicians. Occasionally acupuncture can make people feel nauseous or faint or experience a temporary increase in pain either during or after treatment. Participants are warned of these potential side-effects before consenting to have acupuncture.
Where is the study run from?
1. Beijing Hospital of Traditional Chinese Medicine (China)
2. Beijing ShijItan Hospital (China)
3. Beijing Friendship Hospital, Capital Medical University (China)
When is the study starting and how long is it expected to run for?
January 2014 to December 2016
Who is funding the study?
Beijing Municipal Administration of Hospitals (China)
Who is the main contact?
Dr Xiaomin Wang
wangxiaomin_bhtcm@126.com
Contact information
Scientific
No.23, Back Road of Gallery
Beijing
100010
China
Study information
| Study design | Multi-center randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A multi-center, randomized controlled clinical trial: the effect of acupuncture in the prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer |
| Study hypothesis | To assess the therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting in patients with advanced cancer. |
| Ethics approval(s) | Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 27/11/2014; ref: 2014BL-067 |
| Condition | Chemotherapy-induced nausea and vomiting |
| Intervention | The 136 eligible participants are randomly allocated to two different groups: 1. Participants in the intervention group will receive acupuncture therapy 1 hour prior to chemotherapy administration, 6 hours after chemotherapy administration, and once acupuncture therapy on the following day 2 ,3, 4, 5. The stimulation points are RN12, LR13 (bilaterally), RN6, ST25 (bilaterally), PC6 (bilaterally). They will receive Ondansetron Intravenously twice a day during the chemotherapy administration period. 2. Participants in the control group will receive minimal acupuncture therapy at the same time as the intervention group. The stimulation points do not belong to traditional Chinese medicine. They will receive Ondansetron intravenously twice a day during the chemotherapy administration period. All the patients will complete some questionnaires at the start of the study and at day 1, 2, 3, 7(±1), 10(±1), 14(±1), 21(±1) intervals to find out about any changes in the severity of nausea and vomiting, sleep, appetite and emotion. They will be followed up for 3 weeks to assess long-term effectiveness. |
| Intervention type | Other |
| Primary outcome measure | The Common Terminology Criteria for Adverse Events (CTCAE), formerly called the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. The CTCAE system is a product of the US National Cancer Institute (NCI). It includes the standard to assess nausea and vomiting. It will be assessed at baseline, day 1, day 2, day 3, day 7(±1)，day 10(±1), day 14(±1), day 21(±1). Patients have a daily questionnaire about nausea and vomiting during chemotherapy to record their feelings. |
| Secondary outcome measures | 1. TCM symptoms scale to evaluate TCM syndrome 2. ECOG score scale to evaluate physical condition of patients 3. HADS: a questionnaire to access the anxiety levels of patients 4. Brief nutritional evaluation These measures will be assessed at baseline, day 3, day 7(±1), day 14(±1), day 21(±1). Patients will be assessed with questionaire by doctors. |
| Overall study start date | 01/01/2014 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 136 |
| Participant inclusion criteria | 1. Patients with definite pathological diagnosis of lung cancer, breast cancer, and gynecological cancer 2. Aged 18-75 3. Patients will receive chemotherapy treatment including cisplatin, anthracycline or taxane during the study period 4. ECOG score is between 0 and 2 5. The patients are diagnosed with insufficiency of spleen-qi and stomach-qi, reverse ascending of Stomach-Qi in traditional Chinese medicine theory 6. The expected lifetime of the patient is longer than 6 months 7. Patients willing to participate in the study and sign the consent form |
| Participant exclusion criteria | 1. Patients have serious disease in cardiovascular system, liver system, kidney system, immune system and hemopoietic system 2. Pregnant and lactating women 3. Patients have intractable vomiting caused by malignant brain metastases, intracranial hypertension, digestive tract obstruction, severe liver or renal dysfunction, brain tumors, cerebrovascular disease, or other reasons 4. Patients with coagulopathy, thrombocytopenia, or suffering from bleeding disorders 5. Patients have been definitely diagnosed with depression, anxiety disorders and psychosis 6. Patients with sepsis or bacteremia 7. Patients have lymphedema in acupuncture stimulation area 8. Patients who are afraid of acupuncture stimulation or allergic to stainless steel needles |
| Recruitment start date | 10/12/2014 |
| Recruitment end date | 31/12/2016 |
Locations
Countries of recruitment
- China
Study participating centres
Beijing
100010
China
Haidian
Beijing
-
China
Xicheng
Beijing
-
China
Sponsor information
Government
No.70
Front Road of Zaolin
Xi Cheng District
Beijing
100053
China
"ROR" |
https://ror.org/04baakq55 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/03/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The trialists intend to publish the protocol in March 2015, others to be confirmed at a later date. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/04/2017 | Yes | No | |
| Results article | 03/06/2020 | 06/03/2024 | Yes | No |
Editorial Notes
06/03/2024: Publication reference added.
02/05/2019: No publications found, verifying study status with principal investigator.
24/04/2017: Publication reference added.
