Clinical trial NCT02127255: Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
Official title: Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: chemotherapy
nausea
vomiting
cancer
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
First posted: 2014-04-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience \>15 years) and acupuncturist 2 (\<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments.

Detailed description: This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience \>15 years) and acupuncturist 2 (\<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments. The manual manipulation of two acupuncturists will be recorded by device Acusensor.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of cancer
* Must receive cancer chemotherapy containing cisplatin
* Able to complete at least two continuous chemotherapy treatment cycles
* Karnofsky performance status grade ≥60
* Must 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
* Receiving radiotherapy
* Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
* Severe infection
* Severe heart, liver, kidney and brain diseases
* Unconsciousness
* Psychosis
* Language barriers
* Cardiac pacemaker
* Radiotherapy or hormone therapy during chemotherapy treatments

Primary outcomes:
measure: NCI nausea and vomiting rating scale
timeFrame: day1-8 on each study period
Secondary outcomes:
measure: Rhodes Scale
timeFrame: day1-5 on each study period
measure: global assessment on effectiveness by patients (VAS)
timeFrame: day 5 on each study period
measure: patients' confidence towards acupuncture treatment(VAS)
timeFrame: day 1,5 on each study period
measure: global satisfaction for acupuncture treatments
timeFrame: day 5 on each study period
measure: Acupuncture Expectancy Scale (AES)
timeFrame: day 1, 3, 5 on each study period
Other outcomes:
measure: patient communication satisfaction scale
timeFrame: day 5 on each study period
measure: Acupuncture related adverse events
timeFrame: day 1-5 each study period
measure: Adverse events (not acupuncture treatment specified)
timeFrame: day 1-5 each study period
measure: Needling manipulation parameters
timeFrame: day 1-5 each study period
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: Beijing University of Chinese Medicine
name: Yutong Fei, MD
role: PRINCIPAL_INVESTIGATOR
References: