Standard Care Alone or With Acupuncture for CIPN in Breast Cancer and Multiple Myeloma (ACUFOCIN)

The Christie NHS Foundation Trust

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Multiple Myeloma; Gastrointestinal Cancer; Gynaecological Cancer

Treatments: Procedure: Acupuncture; Other: Medication taken to manage the symptom burden of CIPN

Study type: Interventional

Funder types: Other

Identifiers

NCT02275403

12_DOG06_165

PB-PG-0213-30129 (Other Grant/Funding Number)

CFTSp062 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Arm A: Standard care plus acupuncture

Experimental group

Description:

Medication taken to manage the symptom burden of CIPN plus acupuncture

Treatment:

Procedure: Acupuncture

Other: Medication taken to manage the symptom burden of CIPN

Arm B: Standard care alone

Active Comparator group

Description:

Medication taken to manage the symptom burden of CIPN

Treatment:

Other: Medication taken to manage the symptom burden of CIPN