Breast Cancer Clinical Trial
Official title:
A Pilot Study: Emotions Immunology and Breast Cancer
Pilot study representing a proof of concept regarding the potential for immune system enhancement with psychotherapy, resulting in improved immunological response at lumpectomy or mastectomy in patients undergoing neoadjuvant chemotherapy.
Study participants will receive be randomized to the experimental group (receive
individualized psychotherapy + standard of care) or the control group (standard of care) and
both groups will complete psychological questionnaires. Both groups will have blood sampling
and have their biopsied tissue read for immunological factors.
Patients with triple negative breast cancer or with breast cancers presenting at a large size
(greater than one centimeter) have a worst prognosis than other types of breast cancer or
cancers that are diagnosed when smaller than one centimeter. For these patients, neoadjuvant
chemotherapy, that is chemotherapy given before surgical removal of the cancer, is often
used. Common indications for using neoadjuvant therapy include: available clinical trial,
learning about the tumor response in vivo to a particular chemotherapy and shrinking the
tumor so as to convert a mastectomy to a lumpectomy at the time of resection. In patients
receiving neoadjuvant treatment, there is usually 6-months between the diagnosis and the
surgical breast tumor resection during which the chemotherapy is administered, and during
that time patients are offered support group therapy. Although the prognosis for breast
cancer patients has improved, this subset of patients still poses a clinical challenge.
Growing evidence in the psychological field has documented a link between the immune system
and psychological factors, emphasizing that stress and trauma are detrimental to the ability
and effectiveness of the immune system and emphasizing that mental health has an importance
not only in and of itself on how the person feels, but also translates into physical health
at least in part through the immune system. Personality traits and other emotional factors
remain as viable candidates contributing to the development of malignancies, but the research
in this area is confusing. For example, many authors report that depressed women are more
prone to develop breast cancer than others, while other research has failed to find such a
connection.
Nevertheless, many clinicians notice that cancer tends to present after a major loss or
emotional trauma. Some research suggests that the suppression of negative emotions or
difficulty expressing emotions such as anger and hostility are characteristic of the
cancer-prone personality, so that in a typical study, clinicians who interviewed patients
prior to breast biopsy were able to predict the presence of a malignancy in 94% of cases
based on psychological factors alone. Similarly, a study has been able to predict with 75%
accuracy those patients who had early cancer with no knowledge of their Pap smear results,
based on the presence of extreme hopelessness. However, although there are many similar
studies, other researchers have not been able to confirm the importance of emotional factors.
;
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 |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |