Evaluation of tramadol / acetaminophen combination tablets to evaluate the effectiveness of analgesic treatment in cancer patients who had the symptomatic chemotherapy induced peripheral neuropathy.

Evaluation of tramadol / acetaminophen combination tablets to evaluate the effectiveness of analgesic treatment in cancer patients who had the symptomatic chemotherapy induced peripheral neuropathy. - Tramcet for CIPN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018147

Enrollment

Registered

2015-07-02

Start date

2014-08-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy induced peripheral neuropathy

Interventions

Tramadol / acetaminophen combination tablet is administered orally twice a day at one tablet for the first 7 days. For the following 21 days, it is administered orally four times a day at one tablet,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The patients who previously recieved or are recieving the chemotherapy with platinum agents(oxaliplatin,cisplatin) or taxane are clinically diagnosed as chemotherapy induced peripheral neuropathy(CIPN). 2)For 2 weeks and more, continuation of CIPN of grade2 or 3 in CTCAE v4.0. 3)After a start of the clinical trial, it is anticipated that there are not cancellation of the chemotherapy, a regimen change for at least four weeks. 4)A drug, the dose of the pain-killer (NSAIDs, opioid) did not have a change within four weeks before registration.

Exclusion criteria

Exclusion criteria: 1)In taking acetaminophen or tramadol component. 2)Opioids is cotraindicated. 3)Acetaminophen is contraindicated. 4)The patient that antidepressant, an antiepileptic drug, antiarrhythmic, pregabalin, Goshajinkigan were started within four weeks from registration. 5)Peripheral neuropathy induced by diabetes, alcohol and drugs except platinum agents and taxane. 6)Taking selegiline hydrochloride.

Design outcomes

Primary

Measure	Time frame
Numerical rating scale of numbness four weeks later after an internal use of tramadol / acetaminophen combination tablets starts.	—

Secondary

Measure	Time frame
Functional Assessment of Cancer Therapy- Neurotoxicity (FACT-NTX) Neuropathic Pain Symptom Inventory (NPSI) Safety	—

Countries

Japan

Contacts

Public ContactDaisuke Naruge

School of Medicine, Kyorin University Department of Internal Medicine, Medical Oncology

ecg777@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026