BridgeMD
New treatment option for Colorectal Cancer
Official title Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients
ClinicalTrials.gov ID: NCT05850130
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is included if:
- Agree to participate in this study, voluntarily signing a written informed consent form,
- Aged ≥ 18 years,
- Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2,
- Have histologically or cytologically confirmed gastro-intestinal solid tumors, previously treated with any oxaliplatin-based chemotherapy; a...
You likely can't join if
- Patients is excluded if:
- Had acupuncture sessions for the prevention of chemotherapy-induced side effects in the last 3 months prior to inclusion,
- Had previous and/or current chemotherapy treatments with taxane-based regimens (e.g., the TFOX regimen [docetaxel, oxaliplatin, leucovorin, and...
- Have a history of preexisting clinically-significant peripheral neuropathy due to any cause other than chemotherapy (borrelia infection, human...
- Have a recent history (within 4 weeks prior to start of acupuncture) of abusing alcohol, prescription, or illicit drugs (including cannabinoid), or...
- 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...
See the full eligibility criteria
- Patient is included if:
- Agree to participate in this study, voluntarily signing a written informed consent form,
- Aged ≥ 18 years,
- Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2,
- Have histologically or cytologically confirmed gastro-intestinal solid tumors, previously treated with any oxaliplatin-based chemotherapy; a concomitant radio-chemotherapy course is allowed,
- Had the last oxaliplatin infusion \> 2 weeks before inclusion,
- Present OIPN with a numerical rating score (NRS) ≥ 4/10 at inclusion,
- 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)...
- Are able to understand/read French,
- Are registered in a national health care system (PUMa - Protection Universelle Maladie included),
- Patients is excluded if:
- Had acupuncture sessions for the prevention of chemotherapy-induced side effects in the last 3 months prior to inclusion,
- Had previous and/or current chemotherapy treatments with taxane-based regimens (e.g., the TFOX regimen [docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil]),
- 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...
- 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...
- 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,
- Have limb edema of grade 3 (CTCAE v5),
- Had phytotherapy within 2 weeks before a week 1-14 intervention,
- Are pregnant or breastfeeding,
- Are under the tutorship or guardianship of the state or in custody of the justice system.
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
- Grenoble, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France; Grenoble, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.