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

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ClinicalTrials.gov Identifier: NCT02275403
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Emmie Taylor, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Multiple Myeloma Gastrointestinal Cancer Gynaecological Cancer Procedure: Acupuncture Other: Medication taken to manage the symptom burden of CIPN Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Clinical Trial of Acupuncture Plus Standard Care Versus Standard Care for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Actual Study Start Date : April 13, 2015
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 17, 2018


Arm Intervention/treatment
Experimental: Arm A: Standard care plus acupuncture
Medication taken to manage the symptom burden of CIPN plus acupuncture
Procedure: Acupuncture
10 x weekly sessions (40 minutes per session) of acupuncture by a trained therapist.

Other: Medication taken to manage the symptom burden of CIPN
Standard of care medication to manage CIPN symptoms, as determined by a clinician in accordance with local trust policy. The standard care for CIPN includes a variety of oral medications to manage the altered sensations caused by damage to the peripheral nerves. These oral medications include, but are not limited to; Gabapentin, Amitriptyline and Pregabalin. In addition, medicated creams and gels may be used.

Active Comparator: Arm B: Standard care alone
Medication taken to manage the symptom burden of CIPN
Other: Medication taken to manage the symptom burden of CIPN
Standard of care medication to manage CIPN symptoms, as determined by a clinician in accordance with local trust policy. The standard care for CIPN includes a variety of oral medications to manage the altered sensations caused by damage to the peripheral nerves. These oral medications include, but are not limited to; Gabapentin, Amitriptyline and Pregabalin. In addition, medicated creams and gels may be used.




Primary Outcome Measures :
  1. Change in Measure Yourself Medical Outcome Profile (MYMOP2) score of the most troubling symptom of CIPN [ Time Frame: Baseline, week 6 and week 10 ]
    Assessed from patient completed questionnaire data: MYMOP2


Secondary Outcome Measures :
  1. Change in grade of CIPN [ Time Frame: 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

  2. Change in use of concomitant CIPN related medication [ Time Frame: Up to 10 weeks after baseline ]
    Includes change in dose and change in medication used to manage the symptom burden of CIPN.

  3. Change in chemotherapy dosage [ Time Frame: Up to 10 weeks after baseline ]
  4. Pain related scores [ Time Frame: Up to 10 weeks after baseline ]
    Captured by the patient at baseline and then daily in the patient diary from week 1

  5. Quality of life [ Time Frame: 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

  6. Acupuncture treatment compliance [ Time Frame: From week 1 (start of acupuncture treatment) until week 10 ]
    Compliance to attending weekly acupuncture sessions

  7. Preliminary health economic evaluation of cost effectiveness [ Time Frame: 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.

  8. Uptake of the offer of acupuncture at 10 weeks [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275403


Locations
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United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
The Royal Oldham Hospital
Oldham, United Kingdom, OL1 2JH
Sponsors and Collaborators
The Christie NHS Foundation Trust
Investigators
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Study Chair: Andrew Wardley The Christie NHS Foundation Trust

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Responsible Party: Emmie Taylor, Clinical Trials Project Manager, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02275403     History of Changes
Other Study ID Numbers: 12_DOG06_165
PB-PG-0213-30129 ( Other Grant/Funding Number: NIHR Research for Patient Benefit )
CFTSp062 ( Other Identifier: Sponsor )
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases