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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
No Placebo-Only Group

Summary

This trial is testing if Vitamin B12 can reduce joint pain in women with HR-positive breast cancer who are taking AIs. These women often stop their treatment due to pain, and Vitamin B12 might help by reducing inflammation and pain sensitivity. Vitamin B12 has been studied for its potential to reduce pain and improve quality of life in patients experiencing musculoskeletal symptoms from aromatase inhibitors.

Eligible Conditions
  • Hormone Receptor-positive Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, day 45 (+/- 10 days), and at day 90 (+/- 10 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, day 45 (+/- 10 days), and at day 90 (+/- 10 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in average joint pain according to the Brief Pain Inventory - Short Form (BPI- SF)
Secondary study objectives
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 study objectives
Serum inflammatory cytokine levels (C- reactive protein)

Side effects data

From 2009 Phase 2 trial • 49 Patients • NCT00216099
84%
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
45%
NAUSEA
43%
HEMOGLOBIN
35%
ANOREXIA
29%
COUGH
27%
INSOMNIA
27%
DIARRHEA
27%
DYSPNEA (SHORTNESS OF BREATH)
24%
EDEMA: LIMB
22%
HEARTBURN/DYSPEPSIA
22%
VOMITING
22%
NEUROPATHY: SENSORY
20%
CONSTIPATION
18%
PRURITUS/ITCHING
18%
PAIN / EXTREMITY-LIMB
18%
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
18%
HAIR LOSS/ALOPECIA (SCALP OR BODY)
18%
WATERY EYE (EPIPHORA, TEARING)
16%
MOOD ALTERATION / DEPRESSION
16%
RASH: ACNE/ACNEIFORM
16%
PAIN / BONE
14%
ALKALINE PHOSPHATASE
14%
CREATININE
12%
TASTE ALTERATION (DYSGEUSIA)
12%
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
12%
RASH/DESQUAMATION
12%
HOT FLASHES/FLUSHES
12%
PLATELETS
10%
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
10%
INFECTION - OTHER
10%
NEUROPATHY: MOTOR
10%
PAIN - OTHER
10%
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
8%
URINARY FREQUENCY/URGENCY
8%
CONSTITUTIONAL SYMPTOMS - OTHER
8%
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
8%
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
8%
PAIN / JOINT
8%
LEUKOCYTES (TOTAL WBC)
6%
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
6%
RIGORS/CHILLS
6%
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
6%
PAIN / ABDOMEN NOS
6%
EXTREMITY-LOWER (GAIT/WALKING)
6%
HYPERTENSION
6%
WEIGHT LOSS
6%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
6%
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
4%
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
4%
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
4%
CARDIAC GENERAL - OTHER
4%
PAIN / MUSCLE
4%
DIZZINESS
4%
DERMATOLOGY/SKIN - OTHER
4%
DEHYDRATION
4%
PULMONARY/UPPER RESPIRATORY - OTHER
4%
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
4%
PAIN / BACK
4%
ARTHRITIS (NON-SEPTIC)
4%
OCULAR/VISUAL - OTHER
4%
PAIN / HEAD/HEADACHE
2%
MOOD ALTERATION / ANXIETY
2%
PAIN / EYE
2%
PAIN / INTESTINE
2%
PAIN / STOMACH
2%
PAIN / BREAST
2%
HEMORRHAGE, GI
2%
ALLERGY/IMMUNOLOGY - OTHER
2%
PTT (PARTIAL THROMBOPLASTIN TIME)
2%
OBSTRUCTION, GU / PROSTATE
2%
NAIL CHANGES
2%
PAIN / EXTREMITY-LIMB- HAND
2%
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
2%
FLUSHING
2%
MUSCULOSKELETAL/SOFT TISSUE - OTHER
2%
EXTREMITY-UPPER (FUNCTION)
2%
MOOD ALTERATION / AGITATION
2%
RENAL/GENITOURINARY - OTHER
2%
INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
2%
INFECTION WITH UNKNOWN ANC / LYMPHATIC
2%
INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS
2%
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
2%
VESSEL INJURY-VEIN / EXTREMITY-LOWER
2%
PAIN / PERINEUM
2%
URINE COLOR CHANGE
2%
INCONTINENCE, URINARY
2%
PAIN / BLADDER
2%
GASTROINTESTINAL - OTHER
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
2%
PAIN / CHEST/THORAX NOS
2%
HYPOTENSION
2%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
2%
NASAL CAVITY/PARANASAL SINUS REACTIONS
2%
NEUROLOGY - OTHER
2%
PAIN / RECTUM
2%
PAIN / SCALP
2%
HEPATOBILIARY/PANCREAS - OTHER
2%
DIC (DISSEMINATED INTRAVASCULAR COAGULATION)
2%
PAIN / CARDIAC/HEART
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
2%
RASH: HAND-FOOT SKIN REACTION
2%
COGNITIVE DISTURBANCE
2%
CONFUSION
2%
VESSEL INJURY-ARTERY / EXTREMITY-LOWER
2%
EDEMA: TRUNK/GENITAL
2%
GYNECOMASTIA
2%
PAIN / NEURALGIA/PERIPHERAL NERVE
2%
PAIN - OTHER FEET
2%
PAIN / PELVIS
2%
FEBRILE NEUTROPENIA(ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
2%
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
2%
HEMORRHAGE, CNS
2%
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / CATHETER-RELATED
2%
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
2%
CARDIAC ARRHYTHMIA - OTHER
2%
HEMORRHAGE, GI / ANUS
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
2%
PANCREATITIS
2%
PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
2%
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
2%
DISTENSION/BLOATING, ABDOMINAL
2%
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
2%
PAIN / PROSTATE
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
2%
INFECTION WITH UNKNOWN ANC / ABDOMEN NOS
2%
INFECTION WITH UNKNOWN ANC / BLADDER (URINARY)
2%
PAIN / ORAL CAVITY
2%
SODIUM, SERUM-LOW (HYPONATREMIA)
2%
LUMBAR SPINE-RANGE OF MOTION
2%
LYMPHATICS - OTHER
2%
OSTEOPOROSIS
2%
VISION-BLURRED VISION
2%
HEMOGLOBINURIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pemetrexed 500mg/m^2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
469 Previous Clinical Trials
33,470 Total Patients Enrolled
56 Trials studying Breast Cancer
5,108 Patients Enrolled for Breast Cancer
Zeina Nahleh, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
6 Previous Clinical Trials
332 Total Patients Enrolled
5 Trials studying Breast Cancer
291 Patients Enrolled for Breast Cancer

Media Library

Vitamin B12 (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04205786 — N/A
Breast Cancer Research Study Groups: Control - Standard of Care, Study Medication Group (B12)
Breast Cancer Clinical Trial 2023: Vitamin B12 Highlights & Side Effects. Trial Name: NCT04205786 — N/A
Vitamin B12 (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205786 — N/A
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