A Phase 3 interventional study of vitamin E and placebo in Neurotoxicity and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Alliance for Clinical Trials in Oncology. Completed at 69 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-06.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care
RATIONALE: Vitamin E may prevent peripheral neuropathy caused by chemotherapy in patients with cancer. It is not yet known whether vitamin E is more effective than a placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying vitamin E to see how well it works compared with placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of chemotherapy (taxane vs cisplatin vs carboplatin vs oxaliplatin vs combination), age (≤ 50 years vs > 50 years), and gender. Patients are randomized to 1 of 2 treatment arms.
OBJECTIVES:
Primary
Secondary
After completion of study treatment, patients are followed at 6 months.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 207 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Required Characteristics:
Scheduled to undergo curative-intent adjuvant treatment with neurotoxic chemotherapy. Patients must have had his/her tumor removed, but may have microscopic residual disease, or residual margin involvement and still be eligible.
The patient's chemotherapy regimen must include one or more of the following neurotoxic chemotherapeutic agents: taxanes (paclitaxel, docetaxel); platinum compounds (cisplatin, carboplatin, oxaliplatin)-(oxaliplatin patients should preferentially be enrolled in protocol N04C7 while it is available).
Contraindications:
Vitamin E supplementation for any reason ≤ 7 days prior to randomization. (Exception:
one multivitamin per day that contains ≤ 100 IU [mg] of Vitamin E, will be permitted.)
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.
Dietary Supplement: vitamin E
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.
Other: placebo
Given orally
Given orally
Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2
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.
Time frame: 6 months post completion of chemotherapy treatment
Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy
Time frame: 6 months post completion of chemotherapy treatment
Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy
Time frame: 6 months post completion of chemotherapy treatment
Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2
Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.
Time frame: 6 months post completion of chemotherapy treatment
Duration of Sensory Peripheral Neuropathy ≥ Grade 2
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.
Time frame: 6 months post completion of chemotherapy treatment
Two-hundred and seven (207) participants were recruited between December 2006 and December 2007 from 23 North Central Cancer Treatment Group (NCCTG) member sites.
| Milestone | Vitamin E | Placebo |
|---|---|---|
| Started | 96 | 93 |
| Completed | 67 | 60 |
| Not completed | 29 | 33 |
| Withdrew: Withdrawal by subject | 11 | 18 |
| Withdrew: Adverse event | 8 | 3 |
| Withdrew: Alternate treatment | 2 | 4 |
| Withdrew: Other medical problems | 2 | 4 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Other reasons | 6 | 3 |
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.
| percentage of participants | Vitamin E | Placebo |
|---|---|---|
| Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2 | 34 | 29 |
| percentage of patients | Vitamin E | Placebo |
|---|---|---|
| Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy | 3 | 5 |
| percentage of participants | Vitamin E | Placebo |
|---|---|---|
| Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy | 4 | 3 |
Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.
| days | Vitamin E | Placebo |
|---|---|---|
| Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2 | 58 (43 to 97) | 69 (49 to 105) |
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.
| days | Vitamin E | Placebo |
|---|---|---|
| Duration of Sensory Peripheral Neuropathy ≥ Grade 2 | 36 (28 to 44) | NA (NA to NA) |
Collected over Prior to each cycle of chemotherapy to six months post chemotherapy completion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin E | — | 0/96 (0%) | 26/96 (27.1%) |
| Placebo | — | 0/93 (0%) | 25/93 (26.9%) |
| Event | Vitamin E | Placebo |
|---|---|---|
| DiarrheaGastrointestinal disorders | 6/96 | 3/93 |
| ThrombosisVascular disorders | 0/96 | 5/93 |
| NauseaGastrointestinal disorders | 5/96 | 1/93 |
| VomitingGastrointestinal disorders | 5/96 | 0/93 |
| Neutrophil count decreasedInvestigations | 2/96 | 4/93 |
| Peripheral sensory neuropathyNervous system disorders | 3/96 | 4/93 |
| ConstipationGastrointestinal disorders | 0/96 | 3/93 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/96 | 3/93 |
| Leukocyte count decreasedInvestigations | 3/96 | 2/93 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/96 | 2/93 |
| Age, Customized(participants) | Vitamin E | Placebo | Total |
|---|---|---|---|
| <=50 years | 40 | 34 | 74 |
| >50 years | 56 | 59 | 115 |
| Sex: Female, Male(Participants) | Vitamin E | Placebo | Total |
|---|---|---|---|
| Female | 80 | 75 | 155 |
| Male | 16 | 18 | 34 |
| Race (NIH/OMB)(Participants) | Vitamin E | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 5 | 7 |
| White | 91 | 87 | 178 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Vitamin E | Placebo | Total |
|---|---|---|---|
| United States | 96 | 93 | 189 |
| Type of cancer(participants) | Vitamin E | Placebo | Total |
|---|---|---|---|
| Breast | 58 | 57 | 115 |
| Lung | 1 | 4 | 5 |
| Other Cancer | 37 | 32 | 69 |
| Planned number of chemotherapy cycles(participants) | Vitamin E | Placebo | Total |
|---|---|---|---|
| <=4 | 48 | 49 | 97 |
| >4 | 48 | 44 | 92 |
| Type of chemotherapy(participants) | Vitamin E | Placebo | Total |
|---|---|---|---|
| Taxane | 57 | 52 | 109 |
| Cisplatin | 4 | 4 | 8 |
| Carboplatin | 1 | 1 | 2 |
| Oxaliplatin | 24 | 26 | 50 |
| Combination | 10 | 10 | 20 |
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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