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

NCT02127255 | Completed

• 2 other identifiers: EBM@BUCM-1Z111107054511086
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

chemotherapy; nausea; vomiting; cancer

Outcome Measures

Primary Outcomes (1)

• NCI nausea and vomiting rating scale

  day1-8 on each study period

Secondary Outcomes (5)

• Rhodes Scale

  day1-5 on each study period

• global assessment on effectiveness by patients (VAS)

  day 5 on each study period

• patients' confidence towards acupuncture treatment(VAS)

  day 1,5 on each study period

• global satisfaction for acupuncture treatments

  day 5 on each study period

• Acupuncture Expectancy Scale (AES)

  day 1, 3, 5 on each study period

Other Outcomes (4)

• patient communication satisfaction scale

  day 5 on each study period

• Acupuncture related adverse events

  day 1-5 each study period

• Adverse events (not acupuncture treatment specified)

  day 1-5 each study period

Study Arms (2)

A (Acupuncturist 1)

ACTIVE COMPARATOR

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

Procedure: Manual acupuncture implemented by acupuncturist 1

B (Acupuncturist 2)

ACTIVE COMPARATOR

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

Procedure: Manual acupuncture implemented by acupuncturist 2

Interventions

Manual acupuncture implemented by acupuncturist 1 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.

Also known as: Traditional manual acupuncture, Traditional acupuncture

A (Acupuncturist 1)

Manual acupuncture implemented by acupuncturist 2 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.

Also known as: Traditional manual acupuncture, Traditional acupuncture

B (Acupuncturist 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead
• Xiyuan Hospital of China Academy of Chinese Medical Sciences: collaborator

Study Sites (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, 100091, China

Location

MeSH Terms

Conditions

Vomiting; Nausea; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yutong Fei, MD

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate research fellow

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: April 30, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

CN (1)