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

Beijing University of Chinese Medicine

Status: Completed

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Procedure: Manual acupuncture implemented by acupuncturist 1; Procedure: Manual acupuncture implemented by acupuncturist 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02127255

EBM@BUCM-1

Z111107054511086 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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39 participants in 2 patient groups

A (Acupuncturist 1)

Active Comparator group

Description:

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

Treatment:

Procedure: Manual acupuncture implemented by acupuncturist 1

B (Acupuncturist 2)

Active Comparator group

Description:

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

Treatment:

Procedure: Manual acupuncture implemented by acupuncturist 2