Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail

Chemotherapy-induced Nausea and Vomiting Clinical Trial

— ACTIN  

Official title:

Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127255
• Other study ID #: EBM@BUCM-1
• Secondary ID: Z111107054511086
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: April 14, 2016
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Procedure:
• Manual acupuncture implemented by acupuncturist 1
Manual acupuncture once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 1 has to have more than 15 years of acupuncture clinical practice experience.
• Manual acupuncture implemented by acupuncturist 2
Manual acupuncture given by acupuncturist 2 once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 2 has to have less than 5 years of acupuncture clinical practice experience.

Locations

Country	Name	City	State
China	Xiyuan Hospital, China Academy of Chinese Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine	Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient communication satisfaction scale		day 5 on each study period	No
Other	Acupuncture related adverse events	faintng during acupuncture treatment, sticking of needle, bleeding in the needling hole, broken needles	day 1-5 each study period	Yes
Other	Adverse events (not acupuncture treatment specified)		day 1-5 each study period	Yes
Other	Needling manipulation parameters	Displacement Frequency (Hz) Displacement Amplitude (pk-pk) Rotation Frequency (Hz) Rotation Amplitude (pk-pk)	day 1-5 each study period	No
Primary	NCI nausea and vomiting rating scale		day1-8 on each study period	No
Secondary	Rhodes Scale		day1-5 on each study period	No
Secondary	global assessment on effectiveness by patients (VAS)		day 5 on each study period	No
Secondary	patients' confidence towards acupuncture treatment(VAS)		day 1,5 on each study period	No
Secondary	global satisfaction for acupuncture treatments		day 5 on each study period	No
Secondary	Acupuncture Expectancy Scale (AES)		day 1, 3, 5 on each study period	No