NCT00516503 · REGISTRY CONDITION SEARCH

Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2017-08-24

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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]

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outcome · POSTED

Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4

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outcome · POSTED

Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4

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outcome · POSTED

Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)

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outcome · POSTED

Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4

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outcome · POSTED

Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks

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outcome · POSTED

Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > 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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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\>
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: baclofen/amitriptyline/ketamine gel
label
Arm I
type
EXPERIMENTAL
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.
intervention Names
Other: placebo
label
Arm II
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Arm I
description
Applied topically
name
baclofen/amitriptyline/ketamine gel
type
DRUG
arm Group Labels
Arm II
description
Applied topically
name
placebo
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
INVESTIGATOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 208
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The primary analysis was the change in sensory neuropathy subscale of the CIPN-20 from baseline to week 4. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's sensory neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
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]
time Frame
From baseline to 4 weeks

secondary Outcomes

description
The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the motor neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
measure
Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4
time Frame
From Baseline to week 4
description
The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the autonomic neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
measure
Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4
time Frame
Up to 4 weeks
description
Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score.
measure
Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)
time Frame
At 4 weeks
description
Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint. Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.
measure
Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4
time Frame
Up to 4 weeks
description
The Peripheral Neuropathy Questionnaire was used to analyze this endpoint. Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic). The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.
measure
Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks
time Frame
Up to 4 weeks
description
Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
measure
Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > 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
time Frame
Up to 4 weeks

Full study description

brief Summary: 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.
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.

Source references

references

citation
Wolf 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
type
RESULT
citation
Barton 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
type
RESULT
citation
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.
type
RESULT
citation
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.
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice