Clinical trial NCT02842307: Acupuncture for Chemical Therapy Induced Nausea and Vomiting
Official title: Impact of Acupuncturist Expertise on Clinical Effectiveness for Chemotherapy Induced Nausea and Vomiting in Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Acupuncture
Expertise-based randomized controlled trial
Nausea
Vomiting
Cancer
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Dongzhimen Hospital, Beijing
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
First posted: 2016-07-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, patients will be randomized to 4 group, receiving the treatment from senior acupuncturist, junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of treatment is from the first day receiving cisplatin until two days after cisplatin on each group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.

Detailed description: This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, 102 patients will be randomly divided into 4 groups which separately receiving the treatment from senior acupuncturist(clinical experience\> 15 years, considered in this trial as highly expertised), junior acupuncturist(clinical experience\< 5 years, considered in this trial as lower expertised), junior acupuncturist only acupuncture Neiguan(P6), or not receiving the acupuncture. All participants receive the cisplatin-based chemotherapy and 5-HT3 as antiemetic treatment will be included. Acupuncture treatments are given once daily, the duration of treatment is from the first day receiving cisplatin until two days after cisplatin. NCI and Rhode scale will be used to measure the control of nausea and vomiting. only outcome assessors are blinded. Generalized estimating equations will be used to compare the effects among groups.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of cancer
* Must receive cancer chemotherapy containing cisplatin
* Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration

Exclusion Criteria:

* Concurrent neoplasms or illness that induces nausea independent of chemotherapy
* Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
* Severe infection
* Severe heart, liver, kidney and brain diseases
* Cardiac pacemaker
* Radiotherapy or hormone therapy during chemotherapy treatments

Primary outcomes:
measure: NCI nausea and vomiting rating scale
timeFrame: From the first day receiving cisplatin until two days after cisplatin in each group
measure: Rhodes Scale
timeFrame: From the first day receiving cisplatin until two days after cisplatin in each group
Secondary outcomes:
measure: Global assessment on effectiveness by patients (a single direct question with five levels of alternatives)
timeFrame: The second day after cisplatin
measure: Patients' confidence towards acupuncture treatment (a single direct question with five levels of alternatives)
timeFrame: The first day receiving cisplatin and the second day after cisplatin
measure: Consumption of additional antiemetic
timeFrame: From the first day receiving cisplatin until two days after cisplatin
Other outcomes:
measure: Acupuncture related adverse events
timeFrame: From the first day receiving cisplatin until two days after cisplatin
measure: Adverse events
timeFrame: From the first day receiving cisplatin until two days after cisplatin
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing University of Chinese medicine
state: Beijing
city: Beijing
country: China
facility: Guanganmen Hospital,China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
Study officials:
References: