Breast Cancer Clinical Trial
Official title:
Physiology of Chemotherapy Induced Fatigue and Cognitive Dysfunction in Early Stage Breast Cancer
RATIONALE: Gathering information over time from women undergoing chemotherapy for breast
cancer may help doctors learn more about mental and physical fatigue caused by treatment.
PURPOSE: This clinical trial is studying fatigue caused by chemotherapy in women who have
undergone surgery for stage I, stage II, or stage III breast cancer and in healthy
volunteers.
OBJECTIVES:
- To assess treatment-related fatigue, cognitive dysfunction, and recovery in women
undergoing adjuvant chemotherapy for stage I-III breast cancer as compared with a
patient-selected control population.
- To determine whether fatigue induced by sustained isometric contraction (SIC) is more
of central or peripheral (muscular) origin in patients with and without
treatment-related fatigue.
- To characterize changes from baseline in potential abnormal signal processing in the
brain while performing cognitive-assessment testing (CAT) in patients experiencing
chemotherapy-related cognitive dysfunction compared with the controls.
OUTLINE: Patients and participants undergo assessment of treatment-related fatigue and
cognitive dysfunction (i.e., mental fatigue) at baseline, after completion of 3-4 courses of
standard adjuvant chemotherapy, and 1-3 weeks after completion of the most recent treatment.
Patient recovery will be assessed at approximately 1 year from baseline. Study assessments
will include a brief fatigue inventory, a cognitive assessment, and muscle fatigability
testing through a sustained isometric contraction. Additional assessments will include
quantification of brain and muscle signal alterations in patients with and without
treatment-related fatigue and cognitive-assessment testing in patients experiencing
chemotherapy-related cognitive dysfunction.
Patients and participants also undergo collection of data to obtain information on patient
age, body mass index, and menopausal status at baseline and at 1 year. Additional
information is collected on type of chemotherapy treatment and any hormonal or other
anticancer treatments administered throughout the course of the study. Cancer recurrences or
new cancer events are also recorded.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |