NCT02275403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

April 13, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

October 22, 2014

Last Update Submit

January 30, 2019

Conditions

Breast CancerMultiple MyelomaGastrointestinal CancerGynaecological Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in Measure Yourself Medical Outcome Profile (MYMOP2) score of the most troubling symptom of CIPN

    Assessed from patient completed questionnaire data: MYMOP2

    Baseline, week 6 and week 10

Secondary Outcomes (8)

  • Change in grade of CIPN

    Baseline, week 6 and week 10

  • Change in use of concomitant CIPN related medication

    Up to 10 weeks after baseline

  • Change in chemotherapy dosage

    Up to 10 weeks after baseline

  • Pain related scores

    Up to 10 weeks after baseline

  • Quality of life

    Baseline, week 6 and week 10

  • +3 more secondary outcomes

Study Arms (2)

Arm A: Standard care plus acupuncture

EXPERIMENTAL

Medication taken to manage the symptom burden of CIPN plus acupuncture

Procedure: AcupunctureOther: Medication taken to manage the symptom burden of CIPN

Arm B: Standard care alone

ACTIVE COMPARATOR

Medication taken to manage the symptom burden of CIPN

Other: Medication taken to manage the symptom burden of CIPN

Interventions

AcupuncturePROCEDURE

10 x weekly sessions (40 minutes per session) of acupuncture by a trained therapist.

Arm A: Standard care plus acupuncture
Medication taken to manage the symptom burden of CIPNOTHER

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.

Arm A: Standard care plus acupunctureArm B: Standard care alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

The Royal Oldham Hospital

Oldham, OL1 2JH, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsMultiple MyelomaGastrointestinal Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Andrew Wardley

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Trials Project Manager

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 27, 2014

Study Start

April 13, 2015

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)