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Vitamin
Vitamin B12 for Breast Cancer
N/A
Waitlist Available
Led By Zeina Nahleh, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 90 (+/- 10 days)
Awards & highlights
Study Summary
This trial is investigating whether Vitamin B12 can help with the joint pain caused by Aromatase Inhibitors, which is a treatment for hormone receptor-positive breast cancer.
Eligible Conditions
- Hormone Receptor-positive Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, day 45 (+/- 10 days), and at day 90 (+/- 10 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, day 45 (+/- 10 days), and at day 90 (+/- 10 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in average joint pain according to the Brief Pain Inventory - Short Form (BPI- SF)
Secondary outcome measures
Change in worst joint pain according to the BPI-SF
Quality of life (QOL) as measured by Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)
Other outcome measures
Serum inflammatory cytokine levels (C- reactive protein)
Side effects data
From 2009 Phase 2 trial • 49 Patients • NCT0021609984%
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
45%
NAUSEA
43%
HEMOGLOBIN
35%
ANOREXIA
29%
COUGH
27%
INSOMNIA
27%
DYSPNEA (SHORTNESS OF BREATH)
27%
DIARRHEA
24%
EDEMA: LIMB
22%
HEARTBURN/DYSPEPSIA
22%
VOMITING
22%
NEUROPATHY: SENSORY
20%
CONSTIPATION
18%
WATERY EYE (EPIPHORA, TEARING)
18%
HAIR LOSS/ALOPECIA (SCALP OR BODY)
18%
PAIN / EXTREMITY-LIMB
18%
PRURITUS/ITCHING
18%
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
16%
RASH: ACNE/ACNEIFORM
16%
MOOD ALTERATION / DEPRESSION
16%
PAIN / BONE
14%
ALKALINE PHOSPHATASE
14%
CREATININE
12%
TASTE ALTERATION (DYSGEUSIA)
12%
PLATELETS
12%
RASH/DESQUAMATION
12%
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
12%
HOT FLASHES/FLUSHES
10%
INFECTION - OTHER
10%
NEUROPATHY: MOTOR
10%
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
10%
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
10%
PAIN - OTHER
8%
LEUKOCYTES (TOTAL WBC)
8%
URINARY FREQUENCY/URGENCY
8%
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
8%
CONSTITUTIONAL SYMPTOMS - OTHER
8%
PAIN / JOINT
8%
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
6%
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
6%
HYPERTENSION
6%
RIGORS/CHILLS
6%
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
6%
WEIGHT LOSS
6%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
6%
PAIN / ABDOMEN NOS
6%
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
6%
EXTREMITY-LOWER (GAIT/WALKING)
4%
DEHYDRATION
4%
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
4%
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
4%
CARDIAC GENERAL - OTHER
4%
ARTHRITIS (NON-SEPTIC)
4%
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
4%
OCULAR/VISUAL - OTHER
4%
PAIN / HEAD/HEADACHE
4%
PAIN / MUSCLE
4%
PAIN / BACK
4%
PULMONARY/UPPER RESPIRATORY - OTHER
4%
DERMATOLOGY/SKIN - OTHER
4%
DIZZINESS
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
2%
INFECTION WITH UNKNOWN ANC / BLADDER (URINARY)
2%
INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
2%
INCONTINENCE, URINARY
2%
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
2%
HYPOTENSION
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
2%
INFECTION WITH UNKNOWN ANC / ABDOMEN NOS
2%
GYNECOMASTIA
2%
LYMPHATICS - OTHER
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
2%
SODIUM, SERUM-LOW (HYPONATREMIA)
2%
VISION-BLURRED VISION
2%
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
2%
INFECTION WITH UNKNOWN ANC / LYMPHATIC
2%
RASH: HAND-FOOT SKIN REACTION
2%
LUMBAR SPINE-RANGE OF MOTION
2%
NEUROLOGY - OTHER
2%
URINE COLOR CHANGE
2%
PAIN / PERINEUM
2%
PAIN / CARDIAC/HEART
2%
PAIN / PELVIS
2%
CARDIAC ARRHYTHMIA - OTHER
2%
DISTENSION/BLOATING, ABDOMINAL
2%
INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS
2%
OBSTRUCTION, GU / PROSTATE
2%
CONFUSION
2%
DIC (DISSEMINATED INTRAVASCULAR COAGULATION)
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
2%
COGNITIVE DISTURBANCE
2%
GASTROINTESTINAL - OTHER
2%
MOOD ALTERATION / AGITATION
2%
MOOD ALTERATION / ANXIETY
2%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
2%
NASAL CAVITY/PARANASAL SINUS REACTIONS
2%
OSTEOPOROSIS
2%
PAIN / BREAST
2%
PAIN / CHEST/THORAX NOS
2%
PAIN / EXTREMITY-LIMB- HAND
2%
PAIN / INTESTINE
2%
PAIN / NEURALGIA/PERIPHERAL NERVE
2%
PAIN / ORAL CAVITY
2%
PAIN / PROSTATE
2%
PAIN / RECTUM
2%
PAIN / SCALP
2%
PAIN / STOMACH
2%
PAIN - OTHER FEET
2%
PAIN / EYE
2%
PANCREATITIS
2%
PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
2%
NAIL CHANGES
2%
PAIN / BLADDER
2%
FEBRILE NEUTROPENIA(ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
2%
HEMORRHAGE, CNS
2%
HEPATOBILIARY/PANCREAS - OTHER
2%
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / CATHETER-RELATED
2%
VESSEL INJURY-ARTERY / EXTREMITY-LOWER
2%
VESSEL INJURY-VEIN / EXTREMITY-LOWER
2%
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
2%
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
2%
ALLERGY/IMMUNOLOGY - OTHER
2%
EDEMA: TRUNK/GENITAL
2%
HEMOGLOBINURIA
2%
HEMORRHAGE, GI
2%
HEMORRHAGE, GI / ANUS
2%
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
2%
MUSCULOSKELETAL/SOFT TISSUE - OTHER
2%
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
2%
EXTREMITY-UPPER (FUNCTION)
2%
FLUSHING
2%
PTT (PARTIAL THROMBOPLASTIN TIME)
2%
RENAL/GENITOURINARY - OTHER
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pemetrexed 500mg/m^2
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study Medication Group (B12)Experimental Treatment6 Interventions
Day 0:
Baseline questionnaires: FACT-ES, BPI-SF, Assessment of AI Adherence, Demographics, CRF, and Supplemental Agents Reporting Form
Blood collection
Oral intake of Vitamin B12 Daily in the morning
Day 45
Repeat of baseline questionnaires with addition of investigational agent accountability record
Blood collection
Oral intake of Vitamin B12 Daily in the morning
Day 90:
-Repeat of day 45 without additional study drug intake.
Group II: Control - Standard of CareActive Control5 Interventions
Day 0:
Baseline questionnaires: FACT-ES, BPI-SF, Assessment of AI Adherence, Demographics, CRF, and Supplemental Agents Reporting Form
Blood collection
Continue Usual Care
Day 45:
Repeat of baseline questionnaires with addition of vitamin B12 supplements form and investigational agent accountability record
Blood collection
Continue Usual Care
Day 90:
-Repeat of day 45
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin B12
2008
Completed Phase 3
~2540
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,760 Total Patients Enrolled
55 Trials studying Breast Cancer
4,967 Patients Enrolled for Breast Cancer
Zeina Nahleh, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
6 Previous Clinical Trials
331 Total Patients Enrolled
5 Trials studying Breast Cancer
290 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a long-term liver condition.You are currently taking any other experimental medications.You have a history of alcohol or drug abuse within the past year.You have advanced kidney disease.You have had allergic reactions to substances similar to vitamin B12 or other medications used in this study.You are taking 2.5 mg of letrozole (Femara) every day.You are taking exemestane (Aromasin) at a dose of 25 mg per day.You should not have any other medical conditions that could make participating in the study unsafe.You have experienced muscle and joint pain after starting treatment with aromatase inhibitors. This pain should not be caused by a fracture or injury.You cannot be allergic or have a strong reaction to vitamin B12.
Research Study Groups:
This trial has the following groups:- Group 1: Control - Standard of Care
- Group 2: Study Medication Group (B12)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities remaining for patients to participate in this experiment?
"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is presently enrolling participants. It was originally posted on August 12th 2021 and its most recent modification took place on October 14th 2022; 150 patients are needed from one site only."
Answered by AI
How many participants are presently enrolled in this clinical exploration?
"Affirmative. Clinicaltrials.gov states that this clinical trial, initially posted on August 12th 2021, is currently accepting patients for participation. Approximately 150 individuals are needed from 1 medical centre."
Answered by AI
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