Trial Title:
Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients
NCT ID:
NCT05850130
Condition:
Colorectal Cancer
Liver Cancer
Gastric Cancer
Pancreas Cancer
Esophagus Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Esophageal Neoplasms
Peripheral Nervous System Diseases
Conditions: Keywords:
acupuncture
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A multicenter, 2-cohort phase II study:
Cohort 1: randomization into Arm A = Experimental or Arm B = Control
Cohort 2: a single arm.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Acupuncture intervention
Description:
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.
Arm group label:
Arm A
Intervention type:
Other
Intervention name:
No acupuncture
Description:
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).
Arm group label:
Arm B
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria
Patient is included if:
1. Agree to participate in this study, voluntarily signing a written informed consent
form,
2. Aged ≥ 18 years,
3. Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2,
4. Have histologically or cytologically confirmed gastro-intestinal solid tumors,
previously treated with any oxaliplatin-based chemotherapy; a concomitant
radio-chemotherapy course is allowed,
5. Had the last oxaliplatin infusion > 2 weeks before inclusion,
6. Present OIPN with a numerical rating score (NRS) ≥ 4/10 at inclusion,
7. Currently receiving or recently completed chemotherapy (adjuvant, neoadjuvant, or
advanced stage). Patients may receive current chemotherapy treatment (e.g., with
FOLFIRI, 5-fluorouracil, bevacizumab regimens), excluding platinum salts and
taxane-based regimens during the study,
8. Are able to understand/read French,
9. Are registered in a national health care system (PUMa - Protection Universelle
Maladie included),
Exclusion Criteria
Patients is excluded if:
1. Had acupuncture sessions for the prevention of chemotherapy-induced side effects in
the last 3 months prior to inclusion,
2. Had previous and/or current chemotherapy treatments with taxane-based regimens
(e.g., the TFOX regimen [docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil]),
3. Have a history of preexisting clinically-significant peripheral neuropathy due to
any cause other than chemotherapy (borrelia infection, human immunodeficiency virus
infection, hereditary factors, tumor compression, nutritional deprivation, alcohol,
diabetes, etc.),
4. Have a recent history (within 4 weeks prior to start of acupuncture) of abusing
alcohol, prescription, or illicit drugs (including cannabinoid), or medical,
psychological, or social conditions that may interfere with the patient's compliance
with the study intervention, NB: The patient should be informed that drinking
alcohol should be avoided while on study.
5. Have any other condition that, in the opinion of the investigator, is unstable or
could jeopardize the safety of the patient and her/his compliance during the study,
6. Have limb edema of grade 3 (CTCAE v5),
7. Had phytotherapy within 2 weeks before a week 1-14 intervention,
8. Are pregnant or breastfeeding,
9. Are under the tutorship or guardianship of the state or in custody of the justice
system.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre intercommunal de Créteil
Address:
City:
Créteil
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Isabelle COJEAN ZELEK, MD
Investigator:
Last name:
Isabelle COJEAN ZELEK, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Henri Mondor
Address:
City:
Créteil
Country:
France
Status:
Recruiting
Contact:
Last name:
emmanuelle KEMPF, MD
Investigator:
Last name:
Emmanuelle KEMPF, MD
Email:
Principal Investigator
Facility:
Name:
Institu Daniel Hollard
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Camille HERVE, MD
Investigator:
Last name:
Camille HERVE, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Pitié Salpêtrière
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean Baptiste BACHET, MD
Investigator:
Last name:
Jean Baptiste BACHET, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Saint Antoine
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Hélène BOUSSION, MD
Investigator:
Last name:
Hélène BOUSSION, MD
Email:
Principal Investigator
Start date:
November 22, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
GERCOR - Multidisciplinary Oncology Cooperative Group
Agency class:
Other
Source:
GERCOR - Multidisciplinary Oncology Cooperative Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05850130
