Condition category
Signs and Symptoms
Date applied
27/11/2014
Date assigned
28/02/2015
Last edited
12/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 purpose 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 and gynecological cancer can participate in this study.

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 will receive acupuncture therapy 6 times in 5 days. Participants in the control group will receive minimal acupuncture therapy 6 times in 5 days. They will complete some 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 will be followed up for 3 weeks to assess long-term effectiveness.

What are the possible benefits and risks of participating?
All participants will 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?
The study is run from three locations:
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?
From 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Xiaomin Wang

ORCID ID

Contact details

No.23
Back Road of Gallery
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XM201410

Study information

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

Acronym

Study hypothesis

To assess the therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting in patients with advanced cancer.

Ethics approval

Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 27/11/2014; ref: 2014BL-067

Study design

Multi-center randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Mixed

Gender

Both

Target number of participants

136

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

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
No.23, Back Road of Gallery
Beijing
100010
China

Trial participating centre

Beijing ShijItan Hospital
10 Tieyi Road Haidian
Beijing
China

Trial participating centre

Beijing Friendship Hospital
36 Yong'an Road Xicheng
Beijing
China

Sponsor information

Organisation

Beijing Municipal Administration of Hospitals

Sponsor details

No.70
Front Road of Zaolin
Xi Cheng District
Beijing
100053
China

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Beijing Municipal Administration of Hospitals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

I intend to publish the protocol in March 2015, others to be confirmed at a later date.

Intention to publish date

01/03/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes