NCT03143894

Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation

Terminated NA Results posted Last updated 12 May 2021

What this trial tests

NA trial testing tDCS in Breast Cancer in 7 participants. Terminated before completion.

Timeline

21 April 2017

Primary endpoint
24 June 2020

24 June 2020

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	7
Start date	21 April 2017
Primary completion	24 June 2020
Estimated completion	24 June 2020
Sites	3 locations across United States

Drugs / interventions tested

• tDCS — full drug profile →
• Sham tDCS

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Cognitive Dysfunction — all drugs for Cognitive Dysfunction →
• Fatigue — all drugs for Fatigue →

Sponsor

Johns Hopkins University

Who can join

18 and older, female only, with Breast Cancer or Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change on Paced Auditory Serial Attention Test (PASAT) Primary · Baseline and Day 5

Change in auditory working memory as measured by the PASAT prior to and following the intervention. PASAT scores range from 0 to 120, with higher scores reflecting better working memory. Larger positive change scores reflect greater improvement in performance from baseline whereas greater negative change scores reflect declines in performance from baseline.

Group	Value	95% CI
Active tDCS	-1.83	± 5.04
Sham tDCS	1.83	± 14.52

Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) Secondary · Baseline and Day 5

Change in subjective cognitive functioning as measured by the FACT-Cog Perceived Cognitive Impairment scale prior to and following the intervention. Raw scores range from 0 to 72, with higher scores reflecting better perceived cognitive functioning. Larger positive change scores reflect greater improvement in subjective cognitive functioning from baseline whereas greater negative change scores reflect declines in subjective cognitive functioning from baseline.

Group	Value	95% CI
Active tDCS (5 Days)	7.17	± 6.55
Sham tDCS (5 Days)	8.67	± 12.03

Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF) Secondary · Baseline and Day 5

Change in subjective fatigue as measured by the MFSI-SF prior to and following the intervention. Raw scores range from -36 to + 144, with higher scores reflecting greater levels of fatigue. Larger positive change scores reflect greater improvement in fatigue from baseline whereas greater negative change scores reflect declines in fatigue from baseline.

Group	Value	95% CI
Active tDCS (5 Days)	8.5	± 6.02
Sham tDCS (5 Days)	14.83	± 13.69

Sponsor's own description

This study will test the preliminary efficacy of transcranial direct current stimulation (tDCS) to improve fatigue and cognition in women with a history of breast cancer and persistent fatigue.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.