Clinical trial · Interventional
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Neurotoxicity | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| baclofen/amitriptyline/ketamine gel | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: baclofen/amitriptyline/ketamine gel
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- 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.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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\>
References
Publications (4)
- RESULTWolf SL, Barton DL, Qin R, Wos EJ, Sloan JA, Liu H, Aaronson NK, Satele DV, Mattar BI, Green NB, Loprinzi CL. The relationship between numbness, tingling, and shooting/burning pain in patients with chemotherapy-induced peripheral neuropathy (CIPN) as measured by the EORTC QLQ-CIPN20 instrument, N06CA. Support Care Cancer. 2012 Mar;20(3):625-32. doi: 10.1007/s00520-011-1141-9. Epub 2011 Apr 12. PMID 21479990
- RESULTBarton DL, Wos EJ, Qin R, Mattar BI, Green NB, Lanier KS, Bearden JD 3rd, Kugler JW, Hoff KL, Reddy PS, Rowland KM Jr, Riepl M, Christensen B, Loprinzi CL. A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Support Care Cancer. 2011 Jun;19(6):833-41. doi: 10.1007/s00520-010-0911-0. Epub 2010 May 25. PMID 20496177
- RESULTBarton 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.
- RESULTWolf 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.