Breast Cancer Clinical Trial
— ACUFOCINOfficial title:
Randomised Clinical Trial of Acupuncture Plus Standard Care Versus Standard Care for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Verified date | January 2019 |
Source | The Christie NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 17, 2018 |
Est. primary completion date | December 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | The Royal Oldham Hospital | Oldham |
Lead Sponsor | Collaborator |
---|---|
The Christie NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in grade of CIPN | 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 | Baseline, week 6 and week 10 | |
Secondary | Change in use of concomitant CIPN related medication | Includes change in dose and change in medication used to manage the symptom burden of CIPN. | Up to 10 weeks after baseline | |
Secondary | Change in chemotherapy dosage | Up to 10 weeks after baseline | ||
Secondary | Pain related scores | Captured by the patient at baseline and then daily in the patient diary from week 1 | Up to 10 weeks after baseline | |
Secondary | Quality of life | 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 | Baseline, week 6 and week 10 | |
Secondary | Acupuncture treatment compliance | Compliance to attending weekly acupuncture sessions | From week 1 (start of acupuncture treatment) until week 10 | |
Secondary | Preliminary health economic evaluation of cost effectiveness | 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. | Up to 10 weeks after baseline | |
Secondary | Uptake of the offer of acupuncture at 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. | 10 weeks |
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