Breast Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes
RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of
breast cancer.
PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of
magnesium oxide works compared to placebo in treating menopausal women with hot flashes and
a history of breast cancer.
OBJECTIVES:
Primary
- Evaluate the efficacy of magnesium oxide on hot flashes in women with a history of
breast cancer.
Secondary
- Evaluate the side-effect profile of magnesium oxide in this study population.
- Evaluate the effect of magnesium oxide on the secondary outcomes hot flash frequencies,
hot flash severities, toxicities (including diarrhea), and hot flash-related daily
interference on activities.
- Evaluate the effect of magnesium oxide on the change of magnesium level (for the first
150 patients).
OUTLINE: This is a multicenter study. Patients are stratified according to age (18-49 years
vs ≥ 50 years), current tamoxifen and/or selective estrogen receptor modulator (yes vs no),
current aromatase inhibitor (yes vs no), and daily frequency of hot flashes (4-9 vs ≥ 10).
Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).
- Arm II: Patients receive a high-dose of magnesium oxide PO QD.
- Arm III: Patients receive a low-dose of placebo PO QD.
- Arm IV: Patients receive a high-dose of placebo PO QD. In all arms, treatment continues
for 8 weeks in the absence of unacceptable toxicity.
Some patients may continue or crossover to receive magnesium for 4 more weeks.
Patients complete the Hot Flash Diary daily for 9 weeks beginning 1 week before treatment.
They also complete the Symptom Experience Questionnaire, the Profile of Mood States (POMS),
and Hot Flash-Related Daily Interference Scale (HFRDIS) questionnaires periodically during
study treatment.
Patients undergo blood sample collection at baseline and at the end of weeks 5 and 9 for
serum magnesium level analysis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| 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
|
||
| Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Recruiting |
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 |