Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT02275403
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2014-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Care Alone or With Acupuncture for CIPN in Breast Cancer and Multiple Myeloma
Sponsor:
The Christie NHS Foundation Trust
Organization:
Study Overview
Official Title:
Randomised Clinical Trial of Acupuncture Plus Standard Care Versus Standard Care for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACUFOCIN
Brief Summary:
The purpose of this study is to determine whether the addition of acupuncture to standard treatment reduces the level of chemotherapy induced peripheral neuropathy experienced by patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer during or following treatment with neurotoxic chemotherapy.
Detailed Description:
Chemotherapy Induced Peripheral Neuropathy (CIPN) is a significant clinical challenge for patients receiving specific chemotherapy regimen (e.g. taxanes and Bortezomib) and critically, if severe, CIPN can lead to the discontinuation of life prolonging treatment. CIPN poses a major problem for patient care as standard pharmacological treatments for CIPN have been found to be commonly ineffective and are often inadequate due to dosing complexities, delayed analgesic onset and side effects.
A service evaluation of the clinical data secured from using acupuncture to manage CIPN symptoms over a period of 18 months at The Christie National Health Service (NHS) Foundation Trust suggests it has the potential to provide an efficacious management tool to be used in addition to standard medication. This aim of this trial is to formally evaluate a 10 week course of acupuncture in the management of CIPN of grade 2 or above (symptoms experienced have a functional impact, graded in accordance with CTCAE v4.03), in patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer.
This is a randomised, phase II, single-centre, controlled, open label trial . 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, as determined by a clinician in accordance with local trust policy. In addition to this, 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.
A service evaluation of the clinical data secured from using acupuncture to manage CIPN symptoms over a period of 18 months at The Christie National Health Service (NHS) Foundation Trust suggests it has the potential to provide an efficacious management tool to be used in addition to standard medication. This aim of this trial is to formally evaluate a 10 week course of acupuncture in the management of CIPN of grade 2 or above (symptoms experienced have a functional impact, graded in accordance with CTCAE v4.03), in patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer.
This is a randomised, phase II, single-centre, controlled, open label trial . 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, as determined by a clinician in accordance with local trust policy. In addition to this, 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: