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Completed

NCT Number: NCT03317613

Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain

In the oncology area, neuropathic pains are relatively frequent and can be induced by surgery, radiotherapy, or chemotherapy. In usual practice, some units are using qutenza in order to reduce neuropathic pain even though using of this patch for a population of cancer patients has never been demonstrated so far in a prospective study. The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Jean Perrin, Clermont-Ferrand, France

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About this study

Drugs for neuropathic pains are generally represented by antidepressants, anti-epileptics, opioids, lidocaine patch. However, these drugs can frequently be insufficient, and/or can lead to side effects. Qutenza (8% capsaicin patch) presents an interesting alternative.

Qutenza efficacy has been shown in five principal studies conducted on 1988 adults affected by moderate or severe neuropathic pains. All patients presented Postherpetic neuralgia, or HIV associated therapy, or painful diabetic peripheric neuropathies. These studies led to qutenza approbation in Europe and in States in 2009.

In oncology, neuropathic pains are relatively frequent and can be induced by the three big actors of the anti-cancerous therapeutic arsenal (surgery, radiotherapy, chemotherapy). In usual practice, some units are usually using qutenza, but the use of this patch for this kind of patients has not been shown in a prospective study. Advantages of this treatment are numerous, and results presented in other therapeutic area are encouraging its use in oncology.

The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with at least 18 years old;
  • Patient presenting neuropathic pain secondary to an anti-cancerous treatment;
  • Patient presenting a DN4 (Neuropathic Pain in Four Questions) score superior or equal to 4 out of 10
  • Patient presenting a skin without lesion at the painful area
  • Informed consent form signed;
  • Patient affiliated to a social security scheme.

Exclusion criteria

  • Hypersensitivity known to capsaicin;
  • Instable or uncontrolled hypertension;
  • Painful area localised next to eyes;
  • Pregnant or breastfeeding woman;
  • Protected people.

Treatment and study plan

Qutenza

Drug

Patients suffering from neuropathic pain will receive patch of capsaicin (qutenza) on the painful zones. Three months after the first application, patients will be allowed to receive another patch if necessary. They will be able to receive one every three months. They will be followed in the study during one year after the first patch application.

Other names: 8% capsaicin patch

Primary outcomes

  1. Percentage of responders to capsaicin

    Time frame: One month

    Percentage of responders to capsaicin at one month after the first patch application will be calculated with a relief scale completed by patients.

Secondary outcomes

  1. Maximum value of relief

    Time frame: Three months

    Maximum value of relief will be calculated for patients with relief scale completed by patients at three months after the patch application.

  2. Correlation coefficient between the relief score and time before first relief

    Time frame: Three months

    Correlation coefficient between maximal value of relief and time between the beginning of painful signs and first patch application.

  3. Neuropathic pain intensity reported on visual analog scale

    Time frame: One year

    Minimal, average, and maximal values of neuropathic pain reported on visual analog scale will be evaluated.

  4. Number of toxicities reported

    Time frame: One year

    Capsaicin patch induced toxicities will be reported, and quoted according to CTCAE version 4.4.

  5. Number of days of response

    Time frame: One year

    Number of days of response reported by patients where patch are efficient will be reported

  6. Number of days of response to qutenza

    Time frame: One year

    Number of days between the patch set and the apparition of the first effect on patients will be reported.

  7. Size of painful zones

    Time frame: One year

    Size of painful zones will be reported.

  8. Number of prescribed antalgics

    Time frame: One year

    Number of prescribed antalgics will be reported for each patient.

  9. Percentage of patients with a reported chemotherapy

    Time frame: One year

    Percentage of patients with an obligation to report their chemotherapy because of the pain will be calculated.

  10. Percentage of patients who have received at least 75% of the chemotherapy prescribed

    Time frame: One year

    Percentage of patients who have received at least 75% of the chemotherapy prescribed will be reported.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Institut de Cancérologie de la Loire

Registry information

Acronym: CAPSONCO

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 23, 2017
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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