Clinical trial NCT02275403: Standard Care Alone or With Acupuncture for CIPN in Breast Cancer and Multiple Myeloma
Official title: Randomised Clinical Trial of Acupuncture Plus Standard Care Versus Standard Care for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Multiple Myeloma
Gastrointestinal Cancer
Gynaecological Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer who are receiving or who have received neurotoxic chemotherapy treatment for their condition
* The capacity to understand the patient information sheet and the ability to give written informed consent
* Willingness and ability to comply with scheduled visits and study procedures, including the self-report QoL questionnaires and patient diaries
* Age ≥ 18 years; no upper age limit
* CIPN of ≥ Grade II (CTCAE v4.03)
* Platelet count of ≥ 30 x 10\*9/L
* Neutrophil count of ≥ 0.5 x 10\*9/L
* MYMOP2 score of their most troubling CIPN symptom ≥ 3

Exclusion Criteria:

* Patients who have previously received acupuncture for neuropathy
* Patients who have received acupuncture for any indication, other than neuropathy, within the previous 6 months
* Women who are pregnant or breast feeding
* Co-morbidity with a bleeding disorder
* Patients with an aversion to needles

Primary outcomes:
measure: Change in Measure Yourself Medical Outcome Profile (MYMOP2) score of the most troubling symptom of CIPN
timeFrame: Baseline, week 6 and week 10
Secondary outcomes:
measure: Change in grade of CIPN
timeFrame: Baseline, week 6 and week 10
measure: Change in use of concomitant CIPN related medication
timeFrame: Up to 10 weeks after baseline
measure: Change in chemotherapy dosage
timeFrame: Up to 10 weeks after baseline
measure: Pain related scores
timeFrame: Up to 10 weeks after baseline
measure: Quality of life
timeFrame: Baseline, week 6 and week 10
measure: Acupuncture treatment compliance
timeFrame: From week 1 (start of acupuncture treatment) until week 10
measure: Preliminary health economic evaluation of cost effectiveness
timeFrame: Up to 10 weeks after baseline
measure: Uptake of the offer of acupuncture at 10 weeks
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oldham
country: United Kingdom
facility: The Royal Oldham Hospital
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Andrew Wardley
role: STUDY_CHAIR
References: