ACUFOCIN (standard care alone or with acupuncture for CIPN)
Research type
Research Study
Full title
Randomised clinical trial of acupuncture plus standard care versus standard care for chemotherapy induced peripheral neuropathy (CIPN)
IRAS ID
148709
Contact name
Andrew Wardley
Contact email
Sponsor organisation
Operational Director for Research, The Christie NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Chemotherapy Induced Peripheral Neuropathy (CIPN) is a significant clinical challenge for patients receiving specific chemotherapy regimens (e.g. taxanes and Bortezomib) and critically, if severe, CIPN can lead to the discontinuation of life prolonging treatment. The aim of the study is to formally evaluate the effectiveness of acupuncture as a management tool for this debilitating side effect of treatment.
This study is a single site, randomised controlled trial. The trial population will consist of two distinct patient groups; patients with either metastatic breast cancer or multiple myeloma who are coping with CIPN of grade II or above (CTCAE v4.03).
Patients meeting eligibility criteria will be randomised to receive acupuncture plus standard care (treatment arm) or standard care alone (control arm). Patients in both arms of the study will receive standard medication to manage symptoms of CIPN. In addition to this standard care patients randomised to the treatment arm will receive 40 minute sessions of acupuncture on a weekly basis for 10 weeks. All patients will be offered acupuncture, to commence off trial at the end of their 10 week study period.
Outcome measures have been focused on assessing the impact of acupuncture on the patients’ quality of life, symptom burden of CIPN and quantifying any effect size. There will also be a preliminary health economic evaluation of cost effectiveness. The data will be disseminated in addition to being used to establish whether a larger, multisite trial to confirm efficacy across all diagnostic groups, user acceptability and cost effectiveness is appropriate. This work will facilitate the team validating the study protocol and design as a template for a multicentre study and confirm user acceptability of the approach through additional qualitative data collected through focus group work at the completion of study participation.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
14/NW/1492
Date of REC Opinion
19 Feb 2015
REC opinion
Further Information Favourable Opinion