Trial Outcomes & Findings for Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer (NCT NCT00363129)

NCT ID: NCT00363129

Last Updated: 2016-07-06

Results Overview

The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

207 participants

Primary outcome timeframe

6 months post completion of chemotherapy treatment

Results posted on

2016-07-06

Participant Flow

Two-hundred and seven (207) participants were recruited between December 2006 and December 2007 from 23 North Central Cancer Treatment Group (NCCTG) member sites.

There were a total of 11 cancellations (4 Vitamin E, 7 Placebo), 1 major violation on Placebo and 7 ineligible (3 Vitamin E and 4 Placebo) participants. Of these, 18 participants of cancellations/ineligible were excluded from all analysis.

Participant milestones

Participant milestones
Measure	Vitamin E Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Overall Study STARTED	96	93
Overall Study COMPLETED	67	60
Overall Study NOT COMPLETED	29	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Vitamin E Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Overall Study Withdrawal by Subject	11	18
Overall Study Adverse Event	8	3
Overall Study Alternate Treatment	2	4
Overall Study Other Medical Problems	2	4
Overall Study Death	0	1
Overall Study Other Reasons	6	3

Baseline Characteristics

Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin E n=96 Participants Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo n=93 Participants Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Total n=189 Participants Total of all reporting groups
Age, Customized <=50 years	40 participants n=5 Participants	34 participants n=7 Participants	74 participants n=5 Participants
Age, Customized >50 years	56 participants n=5 Participants	59 participants n=7 Participants	115 participants n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	75 Participants n=7 Participants	155 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants	87 Participants n=7 Participants	178 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants	93 participants n=7 Participants	189 participants n=5 Participants
Type of cancer Breast	58 participants n=5 Participants	57 participants n=7 Participants	115 participants n=5 Participants
Type of cancer Lung	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Type of cancer Other Cancer	37 participants n=5 Participants	32 participants n=7 Participants	69 participants n=5 Participants
Planned number of chemotherapy cycles <=4	48 participants n=5 Participants	49 participants n=7 Participants	97 participants n=5 Participants
Planned number of chemotherapy cycles >4	48 participants n=5 Participants	44 participants n=7 Participants	92 participants n=5 Participants
Type of chemotherapy Taxane	57 participants n=5 Participants	52 participants n=7 Participants	109 participants n=5 Participants
Type of chemotherapy Cisplatin	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Type of chemotherapy Carboplatin	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Type of chemotherapy Oxaliplatin	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants
Type of chemotherapy Combination	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post completion of chemotherapy treatment

Population: Participants who received at least one dose of assigned therapy.

The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.

Outcome measures

Outcome measures
Measure	Vitamin E n=96 Participants Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo n=93 Participants Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2	34 percentage of participants	29 percentage of participants

SECONDARY outcome

Timeframe: 6 months post completion of chemotherapy treatment

Outcome measures

Outcome measures
Measure	Vitamin E n=96 Participants Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo n=93 Participants Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy	3 percentage of patients	5 percentage of patients

SECONDARY outcome

Timeframe: 6 months post completion of chemotherapy treatment

Outcome measures

Outcome measures
Measure	Vitamin E n=96 Participants Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo n=93 Participants Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy	4 percentage of participants	3 percentage of participants

SECONDARY outcome

Timeframe: 6 months post completion of chemotherapy treatment

Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.

Outcome measures

Outcome measures
Measure	Vitamin E n=96 Participants Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo n=93 Participants Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2	58 days Interval 43.0 to 97.0	69 days Interval 49.0 to 105.0

SECONDARY outcome

Timeframe: 6 months post completion of chemotherapy treatment

Duration of sensory peripheral neuropathy is the time from onset of grade 2+ neuropathy until the neuropathy is resolved to grade 1 or less during chemotherapy treatment.

Outcome measures

Outcome measures
Measure	Vitamin E n=33 Participants Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo n=27 Participants Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Duration of Sensory Peripheral Neuropathy ≥ Grade 2	36 days Interval 28.0 to 44.0	NA days Only 6 participants were resolved before the patient went off study thus median days to resolution and 95% Confidence Interval can not be determined.

Adverse Events

Vitamin E

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vitamin E n=96 participants at risk Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.	Placebo n=93 participants at risk Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	2.2% 2/93 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Blood and lymphatic system disorders Hemoglobin decreased	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Cardiac disorders Atrial fibrillation	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Ear and labyrinth disorders Tinnitus	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Gastrointestinal disorders Abdominal pain	2.1% 2/96 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	2.2% 2/93 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Gastrointestinal disorders Constipation	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	3.2% 3/93 • Number of events 4 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Gastrointestinal disorders Diarrhea	6.2% 6/96 • Number of events 9 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	3.2% 3/93 • Number of events 3 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Gastrointestinal disorders Esophageal mucositis	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Gastrointestinal disorders Flatulence	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Gastrointestinal disorders Nausea	5.2% 5/96 • Number of events 6 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Gastrointestinal disorders Vomiting	5.2% 5/96 • Number of events 5 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
General disorders Edema limbs	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	2.2% 2/93 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
General disorders Fatigue	2.1% 2/96 • Number of events 3 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	2.2% 2/93 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
General disorders General symptom	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Immune system disorders Hypersensitivity	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Infections and infestations Abdominal infection	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Infections and infestations Pharyngitis	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Infections and infestations Pneumonia	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Infections and infestations Skin infection	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Infections and infestations Upper respiratory infection	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Infections and infestations Urinary tract infection	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Investigations Coagulopathy	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Investigations Leukocyte count decreased	3.1% 3/96 • Number of events 6 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	2.2% 2/93 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Investigations Lymphocyte count decreased	1.0% 1/96 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Investigations Neutrophil count decreased	2.1% 2/96 • Number of events 3 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	4.3% 4/93 • Number of events 6 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Investigations Platelet count decreased	2.1% 2/96 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	2.2% 2/93 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Metabolism and nutrition disorders Anorexia	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Metabolism and nutrition disorders Dehydration	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Metabolism and nutrition disorders Hypokalemia	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Musculoskeletal and connective tissue disorders Joint pain	2.1% 2/96 • Number of events 6 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Musculoskeletal and connective tissue disorders Myalgia	2.1% 2/96 • Number of events 5 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	2.2% 2/93 • Number of events 2 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Nervous system disorders Dizziness	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Nervous system disorders Headache	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Nervous system disorders Intracranial hemorrhage	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Nervous system disorders Ischemia cerebrovascular	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Nervous system disorders Peripheral sensory neuropathy	3.1% 3/96 • Number of events 3 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	4.3% 4/93 • Number of events 7 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Nervous system disorders Syncope	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Psychiatric disorders Anxiety	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	3.2% 3/93 • Number of events 3 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Respiratory, thoracic and mediastinal disorders Hypoxia	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Skin and subcutaneous tissue disorders Alopecia	2.1% 2/96 • Number of events 3 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Skin and subcutaneous tissue disorders Pruritus	1.0% 1/96 • Number of events 3 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	0.00% 0/93 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Skin and subcutaneous tissue disorders Rash desquamating	1.0% 1/96 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Vascular disorders Hemorrhage	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Vascular disorders Hot flashes	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Vascular disorders Hypertension	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Vascular disorders Thrombosis	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	5.4% 5/93 • Number of events 5 • Prior to each cycle of chemotherapy to six months post chemotherapy completion
Vascular disorders Visceral arterial ischemia	0.00% 0/96 • Prior to each cycle of chemotherapy to six months post chemotherapy completion	1.1% 1/93 • Number of events 1 • Prior to each cycle of chemotherapy to six months post chemotherapy completion

Additional Information

Lisa Kottschade, RN, MSN, CNP

Mayo Clinic

Phone: 507-284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place