Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00516503
First received: August 14, 2007
Last updated: March 17, 2012
Last verified: January 2010
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Purpose
RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy .
PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neurotoxicity Pain Unspecified Adult Solid Tumor, Protocol Specific |
Drug: baclofen/amitriptyline/ketamine gel Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | The Use of Topical Baclofen, Amitriptyline HCI, and Ketamine (BAK) in a PLO Gel vs. Placebo for the Treatment of Chemotherapy Induced Peripheral Neuropathy: A Phase III Randomized Double-Blind Placebo Controlled Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential thrombocythemia
familial acute myeloid leukemia with mutated CEBPA
polycythemia vera
primary myelofibrosis
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Peripheral Nerve Disorders
Drug Information available for:
Amitriptyline
Amitriptyline hydrochloride
Baclofen
Ketamine hydrochloride
Ketamine
Triavil
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 4 [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Motor neuropathy as measured by the EORTC QLQ-CIPN20 at baseline and week 4 [ Designated as safety issue: No ]
- Autonomic symptoms and functioning as measured by the EORTC QLQ-CIPN20 at baseline and week 4 [ Designated as safety issue: No ]
- Mood states and total mood disturbance as measured by the Profile of Mood States-Brief at baseline and week 4 [ Designated as safety issue: No ]
- Pain severity and interference as measured by the Brief Pain Inventory at baseline and week 4 [ Designated as safety issue: No ]
- Numbness, tingling, and pain as measured by the Peripheral Neuropathy Questionnaire at baseline and weekly for 4 weeks [ Designated as safety issue: No ]
- Perception of benefit as measured by the Subject Global Impression of Change at the end of week 4 [ Designated as safety issue: No ]
- Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and evaluated through clinical assessment by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 148 |
| Study Start Date: | February 2008 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
|
Drug: baclofen/amitriptyline/ketamine gel
Applied topically
|
|
Placebo Comparator: Arm II
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
|
Other: placebo
Applied topically
|
Detailed Description:
OBJECTIVES:
Primary
- Compare the effectiveness of baclofen-amitriptyline hydrochloride-ketamine (BAK) gel versus placebo, in terms of improving sensory neuropathy, in cancer patients with chemotherapy-induced peripheral neuropathy.
Secondary
- Compare motor and autonomic symptoms and functioning, mood states, pain, and peripheral neuropathy in these patients.
- Assess the adverse event profile of topical BAK gel.
- Explore whether topical BAK gel is absorbed systemically.
OUTLINE: Patients are stratified according to neurotoxic chemotherapy (active vs non-active), current use of opioids or oral pain medications (yes vs no), pain rating (4-7 vs 8-10), and prior ineffective pharmacologic treatment for peripheral neuropathy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
- Arm II: Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
Some patients in both arms may choose to continue on the active gel or, if on placebo, begin the active gel for an additional 8 weeks off study.
Patients complete health, pain, mood, and quality of life questionnaires at baseline and periodically during study. Patients also record adverse symptoms weekly in a Symptom Experience Diary.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Received or currently receiving neurotoxic chemotherapy including, but not limited to, taxanes (e.g., paclitaxel or docetaxel); platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin); vinca alkaloids (e.g., vincristine or vinblastine); or other neurotoxic chemotherapy agents (e.g., bortezomib, lenalidomide, or thalidomide)
Must have pain or symptoms of peripheral neuropathy attributable to chemotherapy for ≥ 1 month
- Neuropathy is limited to either hands and/or feet where gel can be applied
- Neuropathic pain score of ≥ 4 out of 10 on the numbness/tingling/pain numeric analogue scale
- No pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (e.g., diabetes, alcohol, toxin, heredity)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 4 months
- Creatinine ≤ 1.5 times upper limit of normal
- Not pregnant or nursing
No ability to bear children defined by 1 of the criteria:
- Menopausal (12 months and no menstrual period if natural menopause)
- Underwent a hysterectomy and/or oophorectomy
- Permanent surgical sterilization (tubal ligation)
- Fertile patients must use effective contraception
- Able to complete questionnaires independently or with assistance
- Able to sign informed consent and understand the nature of a placebo-controlled trial
- No history of an allergic reaction to baclofen, amitriptyline hydrochloride, and/or ketamine
- No diagnosis of any New York Heart Association class I-IV congestive heart failure
- No diagnosis of coronary artery disease including, but not limited to, myocardial infarction, within the past 5 years
- No other medical condition that, in the opinion of the treating physician or allied health professional, would make this clinical trial unreasonably hazardous for the patient
- No skin abnormalities at the intended application sites (hands and feet) of study gel (i.e., skin breakdown)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
More than 30 days since prior anticonvulsants, tricyclic antidepressants, monoamine oxidase inhibitor, or other neuropathic pain medication (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, or amifostine)
- Patients treated with any of these agents for peripheral neuropathy for ≤ 1 week during the past 30 days are eligible provided they are no longer taking the agent
More than 5 years since prior percutaneous transluminal coronary angioplasty or coronary artery bypass graft
- Prior heart valve replacement surgery allowed provided patient has fully recovered from the surgery
- No concurrent use of study agents other than as specified in the trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516503
Show 165 Study Locations
Show 165 Study LocationsSponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Study Chair: | Debra Barton, RN, PhD, AOCN, FAAN | Mayo Clinic |
More Information
Additional Information:
Publications:
Barton DL, Wos E, Qin R, et al.: A randomized controlled trial evaluating a topical treatment for chemotherapy-induced neuropathy: NCCTG trial N06CA. [Abstract] J Clin Oncol 27 (Suppl 15): A-9531, 2009.
Wolf SL, Qin R, Barton DL, et al.: Relationship of sensory symptoms and motor function in patients with chemotherapy-induced peripheral neuropathy (CIPN) utilizing the EORTC QLQ CIPN20: NCCTG study N06CA. [Abstract] J Clin Oncol 27 (Suppl 15): A-9587, 2009.
| Responsible Party: | Charles L. Loprinzi, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00516503 History of Changes |
| Other Study ID Numbers: | CDR0000560732, NCCTG-N06CA |
| Study First Received: | August 14, 2007 |
| Last Updated: | March 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific neurotoxicity pain accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia |
chronic phase chronic myelogenous leukemia mast cell leukemia meningeal chronic myelogenous leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage 0 chronic lymphocytic leukemia stage I adult T-cell leukemia/lymphoma stage I chronic lymphocytic leukemia |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Peripheral Nervous System Diseases Lymphoma, Large-Cell, Immunoblastic Neurotoxicity Syndromes Myelodysplastic-Myeloproliferative Diseases |
Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on February 24, 2013
