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

NCT ID: NCT02127255

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-12-31

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A (Acupuncturist 1)

Manual acupuncture implemented by acupuncturist 1 (clinical experience \>15 years)

Group Type: ACTIVE_COMPARATOR

Manual acupuncture implemented by acupuncturist 1

Intervention Type: PROCEDURE

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.

B (Acupuncturist 2)

Manual acupuncture implemented by acupuncturist 2 (clinical experience \< 5 years)

Group Type: ACTIVE_COMPARATOR

Manual acupuncture implemented by acupuncturist 2

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Traditional manual acupuncture; Traditional acupuncture; Traditional manual acupuncture; Traditional acupuncture

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: collaborator

Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yutong Fei

Associate research fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yutong Fei, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing University of Chinese Medicine

Locations

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, , China

Countries

China

Other Identifiers

Z111107054511086

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EBM@BUCM-1

Identifier Type: -

Identifier Source: org_study_id