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| Name | Class |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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The main purpose of this study is to define whether acupuncture in addition to the treatment of physician choice as per standard of care leads to a greater decrease of neuropathic pain as perceived by women with breast cancer who suffer from chemotherapy-induced peripheral neuropathy. Peripheral neuropathy and neuropathic pain of hands and foots will be assessed by using a Number Rate Scale (NRS scale) and data will be compared between standard of care treatment group and acupuncture in addition to standard of care treatment group.
Patients with breast cancer diagnosis and taxane-induced peripheral neuropathy since at least 1 week (CTCAE4.0 Grade 1-3 and NRS≥4) will be enrolled. Patients will be randomized 1:1 in the 2 treatment arms: treatment of physician choice as per standard of care vs acupuncture in addition to standard of care treatment. In experimental arm acupuncture will be performed twice a week for 6 weeks, for a total of 12 sessions. Peripheral neuropathy symptoms and pain at hands and foot will be recorded every day by patients by use of NRS scale. At baseline and every 3 weeks patients will complete CIPN20, EORTC QL30, SF-36 and BPI in order to compare the course of neuropathic pain and quality of life in the 2 arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Treatment for peripheral neuropathy (including neuropathic pain), according to the standard of care (e.g. "Cetirizine", "Gabapentin"). Patient will be followed-up as per protocol for a total of 9 weeks . |
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| Arm B | Experimental | In addition to the treatment for peripheral neuropathy and neuropathic pain, according to the standard of care (e.g. "Cetirizine", "Gabapentin"), patient will receive acupuncture administration twice a week and for a 6-week treatment period. Patient will also be followed-up for 3 weeks after the end of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | acupuncture administration |
| |
| treatment of physician choice, according to the standard of care |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of peripheral neuropathy, including neuropathic pain | Reduction of peripheral neuropathy, including neuropathic pain (at least 3 points on the numeric scale rate) after the 6-week treatment period versus before the start of treatment, greater in the experimental than in the control arm. | 6 weeks after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of peripheral neuropathy, including neuropathic pain | Reduction of peripheral neuropathy, including neuropathic pain (at least 3 points on the numeric scale rate) at 3 and 9 weeks after the start of treatment versus before the start of treatment, greater in the experimental than in the control arm | at 3 and 6 weeks after the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Zamagni, MD | Contact | +390512144548 | zamagniclaudio.sper@aosp.bo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Drug |
treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain |
|
| Improvement of peripheral neuropathy, including neuropathic pain, EORTC QLQ-CIPN20/QLQ-C30 questionnaires | Improvement of peripheral neuropathy, including neuropathic pain perceived by patients, assessed with EORTC QLQ-CIPN20/QLQ-C30 questionnaires, at 3, 6 and 9 weeks after the start of treatment versus before the start of treatment, greater in the experimental arm compared to the control arm. | at 3, 6, 9 weeks after the start of treatment |
| Improvement of the quality of life, SF-36 questionnaire | Improvement of the quality of life as assessed with the SF-36 questionnaire at 6 weeks after the start of treatment versus before the start of treatment, greater in the experimental arm compared to control arm. | 6 weeks after the start of treatment |
| Improvement of peripheral neuropathy, including neuropathic pain, BPI questionnaire | Improvement of peripheral neuropathy, including neuropathic pain perceived by patients, assessed with BPI questionnaire, at 6 weeks after the start of treatment versus before the start of treatment, greater in the experimental arm compared to control arm. | 6 weeks after the start of treatment |
| Improvement of peripheral neuropathy, including neuropathic pain, NCICTCAE v 4.03 criteria | Improvement of peripheral neuropathy, including neuropathic pain evaluated by the clinician according to NCICTCAE v 4.03 criteria, at 3, 6 and 9 weeks after the start of treatment versus before the start of treatment, greater in the experimental arm compared to the control arm. | at 3, 6, 9 weeks after the start of treatment |
| Type and frequency of adverse events occurrence due to acupuncture | Comparison of the type and frequency of adverse events occurred in the two treatment arms. | at last visit, 9 weeks from start of treatment |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative Oncology | Recruiting | Rome | 00168 | Italy |
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| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |