The primary objective is to determine whether in patients with CIPN pain, treatment with Qutenza has the same effect as treatment with duloxetine
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain severity at week 12 after start of treatment as measured by the NRS.
Secondary outcome
1. Interference score (BPI) at week 6 and 12
2. Side effect profile at week 1,2,3,4,5 and 6
3. Quality of life (EQ-5D-5L) at week 6 and 12
4. Patient satisfaction (GPE) at week 1,2,3,4,5,6,8,10 and12
5. Pain score (NRS) at week Pain at 1,2,3,4,5,6, 8 and 10 weeks after the start
of treatment
Background summary
Painful polyneuropathy occurs in approximately 20-40% of patients after the
chemotherapy treatment and has a negative influence on quality of life.
Nowadays the American Society of Clinical Oncology (ASCO) recommends duloxetine
as treatment for CIPN. (Abdi, 2018, p. 588; Hershman et al., 2014, p. 1953)
Duloxetine seems to lead to a significant reduction of neuropathic pain, though
the evidence for duloxetine and other pharmacological treatment is very poor.
(Abdi, 2018, p. 581) Furthermore adverse effects are registered such as
somnolence, insomnia, nausea and vomiting. (Salehifar et al., 2020, p. 250;
Song et al., 2020) In addition, the majority of studies are small and use very
specific in- and exclusion criteria, resulting in no clinically important
differences in outcomes.
Qutenza is another possibility for peripheral neuropathic pain treatment
(Blair, 2018, p. 1496; Dahan et al., 2012, p. 51) with promising results among
patients with CIPN according to a recent study. (Anand et al., 2019, p. 2042)
Qutenza is a patch with 8% capsaicin, which is a selective agonist of a
transient receptor potential vanilloid-1 (TRPV-1). Qutenza is already
registered for the treatment of peripheral neuropathic pain in adults. Research
shows 30% pain reduction in patients with diabetic polyneuropathy, HIV induced
polyneuropathy and post-herpetic neuralgia after using Qutenza versus 20% in
patients receiving a placebo. (Blair, 2018, p. 1498) Skin biopsies of patients
with CIPN showed a decrease of intra-epidermal and sub-epidermal nerve fibers.
(Anand et al., 2019, p. 2042) Treatment with a Qutenza patch possibly leads to
increase or even normalization of intra- and sub-epidermal nerve fibers,
epidermal levels of Nerve Growth Factor, Neurotrophin-3 and Langerhans cells.
Also, no systemic side effects were found when using Qutenza patches. (Anand et
al., 2019, p. 2042).
To our knowledge, no previous randomized study examineds Qutenza in patients
with CIPN, and no study compared Qutenza to duloxetine.
Study objective
The primary objective is to determine whether in patients with CIPN pain,
treatment with Qutenza has the same effect as treatment with duloxetine
Study design
a pragmatic randomized strategy controlled trial
Intervention
The affected extremity or extremities will be treated with Qutenza (179mg)
according to normal procedures of the hospital and as recommended by the
manufacturer.
Patients randomized to duloxetine will start with duloxetine 30 mg per day.
After 1 week the dose of duloxetine will be increased, if tolerated, to 60 mg
per day or more. According to the expertise of the treating specialist the
duloxetine may be increased further to reach a desirable effect.
Study burden and risks
The risk is negligible. Qutenza and duloxetine are licensed drugs and are both
used for the treatment of CIPN. The study compares the effect of both drugs.
The extend of the burden is small. At 10 times (week 0, 1,2,3,4,5 6, 8, 10 eand
12) the patients have to complete several questionnaires, which takes an
estimated 15 minutes.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years of age
- Presence of CIPN grade 1 or higher according to the NCIC-CTC
- Treatment with chemotherapy in the last 5 years
- Able to give oral and written informed consent
- Painful neuropathy with mean pain (1 week) score of >= 4
Exclusion criteria
- Peripheral neuropathy from other causes (e.g. carpal/tarsal tunnel syndrome,
radiculopathy,
spinal stenosis, brachial plexopathy)
- Leptomeningeal carcinomatosis
- Use of selective serotonin reuptake inhibitors, exchanging for medication
without interaction is
possible following expertise of the pain specialist anti-depressant
medication
- Psychiatric disorders which can interfere with cooperation
- Abnormal renal (< GFR 30) or liver function tests (> 2 times normal value)
- Severe heart failure as determined by the cardiologist
- Allergy for duloxetine or capsaicin
- Skin diseases in hands and/or feet, damaged skin
- The presence of uncontrolled/untreated hypertension
- Concomitant use of medication that may interact with duloxetine such as
fluvoxamine, ciprofloxacin and enoxacin which is not replaceable and according
to the treating specialist not safe to combine with duloxetine
- Any condition that by the judgement of the investigator might interfere with
the investigation
- Previous treatment with Qutenza or duloxetine for CIPN
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79669.029.21 |