Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2011
A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00516503 (The Use of Topical Baclofen, Amitriptyline HCI, and Ketamine), which is not on this map. Cited by 99 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
99 citing papers in PubMed, 9 syntheses or guidelines pooled it, 250 citations in OpenAlex.
- BeyondFrontiers in pain research (Lausanne, Switzerland) · 2025Pooled it
- Evidence-Based Treatment of Pain in Chemotherapy-Induced Peripheral Neuropathy.Current pain and headache reports · 2023Pooled it
- Assessing chemotherapy-induced peripheral neuropathy with patient reported outcome measures: a systematic review of measurement properties and considerations for future use.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Pooled it
- Treatment for chemotherapy-induced peripheral neuropathy: A systematic review of randomized control trials.Frontiers in pharmacology · 2022Pooled it
- Systematic review of the effectiveness of self-initiated interventions to decrease pain and sensory disturbances associated with peripheral neuropathy.Journal of cancer survivorship : research and practice · 2020Pooled it
- The effect of analgesics on stimulus evoked pain-like behaviour in animal models for chemotherapy induced peripheral neuropathy- a meta-analysis.Scientific reports · 2019Pooled it
- Herbal medicinal products or preparations for neuropathic pain.The Cochrane database of systematic reviews · 2019Pooled it
- Current use of drugs affecting the central nervous system for chemotherapy-induced peripheral neuropathy in cancer patients: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2015Pooled it
- Combination pharmacotherapy for the treatment of neuropathic pain in adults.The Cochrane database of systematic reviews · 2012Pooled it
- Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Trial
- Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020Trial
- Trial
- Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer.Breast cancer research and treatment · 2016Trial
- Effect of duloxetine in Japanese patients with chemotherapy-induced peripheral neuropathy: a pilot randomized trial.International journal of clinical oncology · 2015Trial
- Pilot evaluation of Scrambler therapy for the treatment of chemotherapy-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2015Trial
- A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2014Trial
- Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014Trial
- Randomized double-blind placebo-controlled trial of acetyl-L-carnitine for the prevention of taxane-induced neuropathy in women undergoing adjuvant breast cancer therapy.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013Trial
- Trial
- 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.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2012Trial
39 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 8 institutions in 1 country.
Funding
Abstract
backgroundChemotherapy-induced peripheral neuropathy (CIPN) is a troublesome chronic symptom that has no proven pharmacologic treatment. The purpose of this double-blind randomized placebo-controlled trial was to evaluate a novel compounded topical gel for this problem.
methodsPatients with CIPN were randomized to baclofen 10 mg, amitriptyline HCL 40 mg, and ketamine 20 mg in a pluronic lecithin organogel (BAK-PLO) versus placebo (PLO) to determine its effect on numbness, tingling, pain, and function. The primary endpoint was the baseline-adjusted sensory subscale of the EORTC QLQ-CIPN20, at 4 weeks.
resultsData in 208 patients reveal a trend for improvement that is greater in the BAK-PLO arm over placebo in both the sensory (p = 0.053) and motor subscales (p = 0.021). The greatest improvements were related to the symptoms of tingling, cramping, and shooting/burning pain in the hands as well as difficulty in holding a pen. There were no undesirable toxicities associated with the BAK-PLO and no evidence of systemic toxicity.
conclusionTopical treatment with BAK-PLO appears to somewhat improve symptoms of CIPN. This topical gel was well tolerated, without evident systemic toxicity. Further research is needed with increased doses to better clarify the clinical role of this treatment in CIPN.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.