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ACUPOX is a multicenter, open label, 2-cohort based phase II clinical study evaluating the interest of a standardized protocol of verum acupuncture in treatment of Oxaliplatin-induced peripheral neuropathy in patients with gastro-intestinal solid tumors who discontinued oxaliplatin-containing chemotherapy.
In this design, patients will be randomized into two-arm (2:1 allocation) Cohort 1: a comparative randomized design (Arm A = Experimental vs Arm B = Control) or included into Cohort 2: a single arm design.
The study follows the Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guideline.
All acupuncture interventions will be conducted by a physician acupuncturist. If the patient will be getting chemotherapy (that is optional treatment) during the study duration, acupuncture will be given at the same time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | 6 weeks of acupuncture once a week. At week 7, patients will be assessed for the primary endpoint Then ,the patient may receive an optional 6 weeks of acupuncture. This option of acupuncture continuation will be left to the patient choice in agreement with a physician acupuncturist. |
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| Arm B | Active Comparator | 6 weeks without acupuncture. At week 7, patients will be assessed for the primary endpoint. Then, the patient will receive or not acupuncture intervention:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture intervention | Other | 6 weeks of acupuncture once a week. The acupuncture intervention will consist of weekly session administered over a period of 6 weeks (± 4 days). A two-way verum acupuncture treatment protocol will employ 8 selected acupoints. After week 7, patients included in Arm A may receive an optional 6 weeks of acupuncture. This option of acupuncture continuation will be left to the patient choice in agreement with a physician acupuncturist. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-point improvement in the global NRS | The primary endpoint is a 2-point improvement in the global numeric rating scale (NRS) score from randomization/inclusion defined by the patient at week 7. The 11-point NRS range from 0 to 10 (0 = no symptom, 1-3 = mild, 4-6 = moderate, 7-10 = severe). | Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) score | A success of acupuncture for the patient is defined by a 2-point improvement on the overall NRS between baseline and week 7 after the randomization of Cohort 1 and inclusion of Cohort 2. | Week 7 |
| Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire |
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Inclusion Criteria
Patient is included if:
Exclusion Criteria
Patients is excluded if:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Line GARCIA LARNICOL | Contact | 0140298500 | regulatory.affairs@gecor.com.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuelle Kempf, MD | Henri Mondor University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre intercommunal de Créteil | Not yet recruiting | Créteil | France |
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A multicenter, 2-cohort phase II study:
Cohort 1: randomization into Arm A = Experimental or Arm B = Control
Cohort 2: a single arm.
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| No acupuncture | Other | The patient in the Arm B will not receive acupuncture treatment for a period of 6 weeks after randomization (weeks 1-6) and during the following weeks 8-13 (acupuncture intervention) if its NRS score is <4/10 at week 7. If the patient' NRS score is ≥ 4/10 at week 7, the patient in control Arm B will receive the same acupuncture intervention that the patient in the Arm A (6 weeks). |
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The EORTC QLQ-CIPN20 questionnaire consists of 20 items that are divided into 3 subscales: the items in CIPN20 have been divided into three subscales. The sensory subscale consists of items 1, 2, 3, 4, 5, 6, 9, 10, and 18; motor: items 7, 8, 11, 12, 13, 14, 15, and 19; and autonomic nerve-related: items 16, 17, and 20. Each subscale is summed and linearly transformed to a score that can range from 0 to 100, where higher scores represent greater CIPN symptom severity. Patients will rate their experience for each symptom during the previous week using scores from 1 (not at all) to 4 (very much). |
| Assess at baseline, at week 7, 14, and at 6 months |
| Brief Pain Inventory (BPI) score | This 9-item BPI self-reported questionnaire provides information on the intensity of pain and the degree to which pain interferes with function. Pain is rated over the prior week and the degree to which the pain interferes with activities using a 0 to 10-point scale. | Assess at baseline, at week 7, 14, and at 6 months |
| Peripheral sensory neuropathy grading scale | Severity of the peripheral sensory neuropathies will be classified using a 4-point scale ranging from grade 1 to grade 4 per criteria established in NCI CTCAE v. 5.0. | Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months |
| Hôpital Henri Mondor | Recruiting | Créteil | France |
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| Institu Daniel Hollard | Not yet recruiting | Grenoble | France |
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| Hôpital Pitié Salpêtrière | Not yet recruiting | Paris | France |
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| Hôpital Saint Antoine | Recruiting | Paris | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D008113 | Liver Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008107 | Liver Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
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