Biomarkers of Fatigue in Breast Cancer version 1
Research type
Research Study
Full title
Is there a correlation between self-reported cancer-related fatigue and biomarkers of fatigue?
IRAS ID
278636
Contact name
Jennifer Pollard
Contact email
Sponsor organisation
RD&I department
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
Background
Cancer-related fatigue (CRF) is a common side effects of cancer and can occur long after treatment is completed (1–6). Fatigue can negatively impact all aspects of quality of life (QOL)(2,4,7) and has been reported as an independent predictor of survival(8).
Recent studies acknowledge inflammation as a key biological pathway for CRF(1,3), focusing on pro-inflammatory markers interleukin 1 (IL-1), interleukin 6 (IL-6) and C-reactive protein (CRP)(1,7,9,10). However, systematic reviews have suggested inconsistent results(11,12).
A number of approaches have proven beneficial in managing CRF, including exercise and psychosocial interventions. Identifying patients at increased risk of developing CRF during treatment could lead to targeted therapies minimising impact on QOL, and potentially affecting survival.Methodology
This feasibility study will look at correlation between self-reported fatigue and biomarkers of fatigue in patients with low-risk breast cancer. Data will be used to power a larger study to ascertain whether biomarkers can be used in early identification of patients at risk of CRF, which can be used to tailor interventions.Both subjective and objective measurements of CRF will be obtained. Subjective assessment of fatigue levels before and after surgery will be provided by completion of a validated fatigue questionnaire. Qualitative analysis of free-text responses will be undertaken, as well as comparison between pre- and post-operative fatigue scores.
Analysing peripheral blood levels of CRP & IL-6 will provide objective assessment of fatigue. Percentage change in the pre- and post-operative results will be used for analysis and compared with the self-reported fatigue scores to evaluate for correlation.Patients will be prospectively identified from the weekly Breast Cancer MDT. 10 patients (40 blood samples) will provide enough data for analysis.
All female patients over 16 years old with low-risk breast cancer will be included. Exclusion criteria include significant medical comorbidities, neoadjuvant/adjuvant chemotherapy, high-risk breast cancer and post operative complications.
Summary of Results
Study was terminated due to failure to recruit adequate numbers. No study results have been obtained.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0233
Date of REC Opinion
17 Nov 2020
REC opinion
Further Information Favourable Opinion