NCT02553863

Brief Summary

The purpose of this study is to determine whether a course of acupuncture is effective in the management of peripheral neuropathy related pain in patients receiving chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

September 8, 2015

Last Update Submit

February 22, 2018

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

chemotherapy induced peripheral neuropathyacupuncturepaincost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Pain

    measured using the Brief Pain Inventory which measures pain intensity and its interference with function.

    at baseline, end of 8-week treatment, 14 weeks and 20 weeks (the latter two to assess possible longer term effects)

Secondary Outcomes (7)

  • Grade of CIPN

    at baseline, end of 8-week treatment

  • Severity of neuropathy

    at baseline, end of 8-week treatment

  • Quality of life

    at baseline, end of 8-week treatment, 14 weeks and 20 weeks (the latter two to assess possible longer term effects)

  • Sensory examination

    at baseline, end of 8-week treatment

  • Measurement of costs

    at baseline, end of 8-week treatment, 14 weeks and 20 weeks (the latter two to assess possible longer term effects)

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Acupuncture for 30min \[twice weekly for 8 weeks\]

Procedure: Acupuncture

Control group

OTHER

Standard care

Procedure: Standard care

Interventions

AcupuncturePROCEDURE

Acupuncture for 30min \[twice weekly for 8 weeks\]

Intervention group
Standard carePROCEDURE

Standard care

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of lung cancer receiving chemotherapy with curative intend, and breast or gynaecological cancer, head \& neck and colorectal cancer stage I, II or III.
  • Currently receiving neurotoxic chemotherapy (taxanes, cisplatin,,carboplatin, etc)
  • Reporting tingling in hands/feet and other indications of chemotherapy-induced peripheral neuropathy (CIPN) after initiation of cancer treatments, confirmed to be indicative of CIPN by a consultant.
  • Not using any medication for the prevention or treatment of CIPN for the past 31 months
  • Willing to participate and be randomised to one of the study groups.
  • No previously established peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Queen Elizabeth Hospital

Tsim Sha Tsui, Hong Kong

Location

Related Publications (2)

  • Molassiotis A, Dawkins B, Longo R, Suen LK, Cheng HL, Mok T, Hulme CT, Yeo W. Economic evaluation alongside a randomised controlled trial to assess the effectiveness and cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy. Acupunct Med. 2021 Feb;39(1):41-52. doi: 10.1177/0964528420920285. Epub 2020 May 13.

    PMID: 32404001DERIVED

  • Molassiotis A, Suen LKP, Cheng HL, Mok TSK, Lee SCY, Wang CH, Lee P, Leung H, Chan V, Lau TKH, Yeo W. A Randomized Assessor-Blinded Wait-List-Controlled Trial to Assess the Effectiveness of Acupuncture in the Management of Chemotherapy-Induced Peripheral Neuropathy. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419836501. doi: 10.1177/1534735419836501.

    PMID: 30905173DERIVED

MeSH Terms

Conditions

Pain

Interventions

Acupuncture TherapyStandard of Care

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Alex MOLASIOTIS, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of School, School of Nursing

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 18, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

HK(2)