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

Phase 2

Completed

• Conditions: Breast Cancer; Multiple Myeloma; Gastrointestinal Cancer; Gynaecological Cancer
• Interventions: Procedure: Acupuncture; Other: Medication taken to manage the symptom burden of CIPN

• Registration Number: NCT02275403
• Lead Sponsor: The Christie NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Study Start: 2015-04-13
• Primary Completion: 2018-12-17
• Study Completion: 2018-12-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Standard care plus acupuncture	Medication taken to manage the symptom burden of CIPN	Medication taken to manage the symptom burden of CIPN plus acupuncture
Arm A: Standard care plus acupuncture	Acupuncture	Medication taken to manage the symptom burden of CIPN plus acupuncture
Arm B: Standard care alone	Medication taken to manage the symptom burden of CIPN	Medication taken to manage the symptom burden of CIPN

Primary Outcome Measures

Name	Time	Method
Change in Measure Yourself Medical Outcome Profile (MYMOP2) score of the most troubling symptom of CIPN	Baseline, week 6 and week 10	Assessed from patient completed questionnaire data: MYMOP2

Secondary Outcome Measures

Name	Time	Method
Change in grade of CIPN	Baseline, week 6 and week 10	Assessed by a clinician using a set of standardised questions, as a prompt, to assess the functional impact of CIPN. CIPN will be graded in accordance with CTCAE v4.03
Quality of life	Baseline, week 6 and week 10	Assessed from patient completed questionnaire data: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and the associated CIPN20 module
Acupuncture treatment compliance	From week 1 (start of acupuncture treatment) until week 10	Compliance to attending weekly acupuncture sessions
Uptake of the offer of acupuncture at 10 weeks	10 weeks	All patients will be offered acupuncture, to commence after the 10 week study period, at the 6 week visit. Acceptance of the offer will be captured at the 10 week visit.
Pain related scores	Up to 10 weeks after baseline	Captured by the patient at baseline and then daily in the patient diary from week 1
Change in use of concomitant CIPN related medication	Up to 10 weeks after baseline	Includes change in dose and change in medication used to manage the symptom burden of CIPN.
Change in chemotherapy dosage	Up to 10 weeks after baseline
Preliminary health economic evaluation of cost effectiveness	Up to 10 weeks after baseline	Data will be captured from patient diaries completed continuously from week 1 until week 10 and from the patient notes. Patients will also complete the Euroqol (EQ-5D-5L) questionnaire at baseline, week 6 and week 10.

Trial Locations

Locations (2)

The Royal Oldham Hospital; 🇬🇧 Oldham, United Kingdom

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom