Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT00058357
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Underwent surgical procedure for cancer diagnosis or treatment
* Experiencing persistent pain for at least 1 month
* Pain must have neuropathic features (e.g., burning, shooting, stabbing, tingling, or pain from light touch)
* Anatomically related to the surgical site and compatible with nerve injury
* Pain rating of at least 4 out of 10 on the pain scale
* No pain of multiple etiologies at the proposed treatment site (e.g., pain of neuropathic and muscular or skeletal origin)
* Painful area must be no larger than can be covered by 3 lidocaine patches\* NOTE: \*Each patch size is 5.5 x 4 inches
* No skin disease, breakdown, infection, or extreme thinning at the site of pain
* No skin or soft tissue malignancy in the painful area
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* At least 6 months
Hematopoietic
* Not specified
Hepatic
* AST ≤ 2 times upper limit of normal
Renal
* Not specified
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to understand and complete questionnaires
* No recent history of or concurrent drug or alcohol abuse
* No mental or psychiatric condition that would preclude giving informed consent
* No history of allergic reaction or intolerance to lidocaine or other amide local anesthetics (e.g., bupivacaine)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior neurotoxic chemotherapy\* with pain in the same area as postsurgical neuropathic pain, except for pain that was present before neurotoxic chemotherapy administration
* No concurrent neurotoxic chemotherapy\* NOTE: \*Including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., cisplatin or carboplatin), or vinca alkaloids (e.g., vincristine or vinblastine)
Endocrine therapy
* More than 7 days since prior topical corticosteroids to the painful area
* No new corticosteroids may be initiated during study participation
Radiotherapy
* No concurrent radiotherapy to the painful area
Surgery
* See Disease Characteristics
Other
* More than 7 days since other prior topical medications to the painful area (including capsaicin)
* No change in current analgesic regimen within the past 10 days
* No new analgesic or adjuvant drugs (e.g., antidepressants, anticonvulsants, or anxiolytics) may be initiated during study participation
* Concurrent stable doses of nonopioid, opioid, and adjuvant analgesic drugs are allowed (including antidepressants or anticonvulsants)
* No concurrent class I antiarrhythmic drugs (e.g., tocainide and mexiletine)
* Concurrent skin lubricants and sunscreen are allowed provided they are not heavily applied
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00058357
Study Brief:
Protocol Section:
NCT00058357