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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 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
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 • NCT0021609984%
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
45%
NAUSEA
43%
HEMOGLOBIN
35%
ANOREXIA
29%
COUGH
27%
DYSPNEA (SHORTNESS OF BREATH)
27%
INSOMNIA
27%
DIARRHEA
24%
EDEMA: LIMB
22%
NEUROPATHY: SENSORY
22%
VOMITING
22%
HEARTBURN/DYSPEPSIA
20%
CONSTIPATION
18%
WATERY EYE (EPIPHORA, TEARING)
18%
HAIR LOSS/ALOPECIA (SCALP OR BODY)
18%
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
18%
PAIN / EXTREMITY-LIMB
18%
PRURITUS/ITCHING
16%
MOOD ALTERATION / DEPRESSION
16%
PAIN / BONE
16%
RASH: ACNE/ACNEIFORM
14%
ALKALINE PHOSPHATASE
14%
CREATININE
12%
PLATELETS
12%
RASH/DESQUAMATION
12%
TASTE ALTERATION (DYSGEUSIA)
12%
HOT FLASHES/FLUSHES
12%
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
10%
PAIN - OTHER
10%
INFECTION - OTHER
10%
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
10%
NEUROPATHY: MOTOR
10%
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
8%
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
8%
URINARY FREQUENCY/URGENCY
8%
LEUKOCYTES (TOTAL WBC)
8%
PAIN / JOINT
8%
CONSTITUTIONAL SYMPTOMS - OTHER
8%
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
6%
RIGORS/CHILLS
6%
EXTREMITY-LOWER (GAIT/WALKING)
6%
WEIGHT LOSS
6%
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
6%
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
6%
HYPERTENSION
6%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
6%
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
6%
PAIN / ABDOMEN NOS
4%
CARDIAC GENERAL - OTHER
4%
PAIN / MUSCLE
4%
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
4%
DIZZINESS
4%
PULMONARY/UPPER RESPIRATORY - OTHER
4%
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
4%
ARTHRITIS (NON-SEPTIC)
4%
PAIN / BACK
4%
PAIN / HEAD/HEADACHE
4%
DEHYDRATION
4%
DERMATOLOGY/SKIN - OTHER
4%
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
4%
OCULAR/VISUAL - OTHER
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
2%
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
2%
HEMORRHAGE, CNS
2%
PAIN / BREAST
2%
HEMORRHAGE, GI
2%
PAIN / PELVIS
2%
GYNECOMASTIA
2%
ALLERGY/IMMUNOLOGY - OTHER
2%
PTT (PARTIAL THROMBOPLASTIN TIME)
2%
VISION-BLURRED VISION
2%
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
2%
INFECTION WITH UNKNOWN ANC / BLADDER (URINARY)
2%
VESSEL INJURY-ARTERY / EXTREMITY-LOWER
2%
FLUSHING
2%
PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
2%
EXTREMITY-UPPER (FUNCTION)
2%
PAIN - OTHER FEET
2%
MOOD ALTERATION / AGITATION
2%
RENAL/GENITOURINARY - OTHER
2%
EDEMA: TRUNK/GENITAL
2%
HEMORRHAGE, GI / ANUS
2%
PAIN / PROSTATE
2%
PANCREATITIS
2%
INFECTION WITH UNKNOWN ANC / LYMPHATIC
2%
INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS
2%
INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
2%
VESSEL INJURY-VEIN / EXTREMITY-LOWER
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
2%
PAIN / PERINEUM
2%
SODIUM, SERUM-LOW (HYPONATREMIA)
2%
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
2%
URINE COLOR CHANGE
2%
INCONTINENCE, URINARY
2%
PAIN / BLADDER
2%
GASTROINTESTINAL - OTHER
2%
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
2%
INFECTION WITH UNKNOWN ANC / ABDOMEN NOS
2%
LUMBAR SPINE-RANGE OF MOTION
2%
MOOD ALTERATION / ANXIETY
2%
PAIN / CHEST/THORAX NOS
2%
PAIN / EYE
2%
CONFUSION
2%
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
2%
OBSTRUCTION, GU / PROSTATE
2%
LYMPHATICS - OTHER
2%
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / CATHETER-RELATED
2%
HYPOTENSION
2%
MUSCULOSKELETAL/SOFT TISSUE - OTHER
2%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
2%
NAIL CHANGES
2%
NASAL CAVITY/PARANASAL SINUS REACTIONS
2%
NEUROLOGY - OTHER
2%
PAIN / EXTREMITY-LIMB- HAND
2%
PAIN / RECTUM
2%
PAIN / SCALP
2%
PAIN / STOMACH
2%
HEPATOBILIARY/PANCREAS - OTHER
2%
DISTENSION/BLOATING, ABDOMINAL
2%
DIC (DISSEMINATED INTRAVASCULAR COAGULATION)
2%
FEBRILE NEUTROPENIA(ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
2%
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
2%
PAIN / CARDIAC/HEART
2%
CARDIAC ARRHYTHMIA - OTHER
2%
COGNITIVE DISTURBANCE
2%
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
2%
PAIN / NEURALGIA/PERIPHERAL NERVE
2%
PAIN / ORAL CAVITY
2%
OSTEOPOROSIS
2%
PAIN / INTESTINE
2%
RASH: HAND-FOOT SKIN REACTION
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
468 Previous Clinical Trials
33,436 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
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.
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