Colorectal CancerACUPOXNCT05850130
Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients
A study testing Acupuncture intervention and No acupuncture in people with Colorectal Cancer and Liver Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Cancer, Gastric Cancer
- What is being tested?
- Acupuncture intervention and No acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 15 sitesFrance
- Study dates
- 22 Nov 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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), excluding platinum salts and taxane-based regimens during the study,
- Are able to understand/read French,
- Are registered in a national health care system (PUMa - Protection Universelle Maladie included),
Who cannot join
- 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, nutritional deprivation, alcohol, diabetes, etc.),
- 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.
- 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,
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- 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.
- Had photobiomodulation therapy sessions in the last month prior to inclusion (this therapy is not permitted during the study)
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 15 recruiting
- Recruiting
CH Amiens-Picardie
Amiens
Vincent HAUTEFEUILLE, MD
- Not yet recruiting
CHU de Caen
Caen
Adeline PASDELOUP, MD
- Recruiting
Centre intercommunal de Créteil
Créteil
Isabelle COJEAN ZELEK, MD
Isabelle COJEAN ZELEK, MD
- Recruiting
Hôpital Henri Mondor
Créteil
emmanuelle KEMPF, MD
Emmanuelle KEMPF, MD
- Recruiting
Ghm - Institut Daniel Hollard
Grenoble
Camille HERVE, MD
Camille HERVE, MD
- Not yet recruiting
CH Lille
Lille
Anne PLOQUIN, MD
- Recruiting
Centre Hospitalier Universitaire de Nimes - Site de Caremeau
Nîmes
Thomas BORDERIE, MD
- Not yet recruiting
Hôpital Bichat
Paris
Gaël GOUJON, MD
- Recruiting
Hôpital Pitié Salpêtrière
Paris
Jean Baptiste BACHET, MD
Jean Baptiste BACHET, MD
- Recruiting
Hôpital Saint Antoine
Paris
Hélène BOUSSION, MD
Hélène BOUSSION, MD
- Recruiting
Institut Curie-Paris
Paris
Celine LAOUISSET, Prof, MD
- Not yet recruiting
Saint-Louis Hospital
Paris
Thomas APARICIO, Prof, MD
- Not yet recruiting
Curie Saint-Cloud
Saint-Cloud
Aude GUILLAUMIN, MD
- Not yet recruiting
Bégin Military Teaching Hospital
Saint-Mandé
Julie LAVOLE, MD
- Recruiting
Paul Brousse Hospital
Villejuif
Pascal HAMMEL, Prof, MD
About this study
Official title: A Multicenter, 2-cohort Phase II GERCOR Study to Evaluate the Interest of Acupuncture on Oxaliplatin-induced Peripheral Neuropathy in Patients With Gastro-intestinal Solid Tumors Who Discontinued Oxaliplatin-based Chemotherapy (ACUPOX)
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.
Read the 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.
- Being tested
- Acupuncture intervention, No acupuncture
- Keywords
- acupuncture
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture interventionOther
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.
No acupunctureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Acupuncture intervention |
| 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:
* A mandatory acupuncture once a week if the patient' NRS global score at week 7 is ≥ 4 .
* No acupuncture if the patient' NRS global score at week 7 is <4, Receives: Other: No acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 7
Secondary outcomes (4)
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.
Measured: Week 7
Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire
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).
Measured: 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.
Measured: 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.
Measured: Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start22 Nov 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Kempf, MD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850130
- Sponsor's protocol ID
- ACUPOX G-114
- Acronym
- ACUPOX
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 2-cohort Phase II GERCOR Study to Evaluate the Interest of Acupuncture on Oxaliplatin-induced Peripheral Neuropathy in Patients With Gastro-intestinal Solid Tumors Who Discontinued Oxaliplatin-based Chemotherapy (ACUPOX)
- ClinicalTrials.gov ID
- NCT05850130
- Acronym / sponsor ID
- ACUPOX / ACUPOX G-114
- Keywords
- acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: Acupuncture intervention6 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. |
| Arm B | Active comparator | Other: No acupuncture6 weeks without acupuncture. At week 7, patients will be assessed for the primary endpoint. Then, the patient will receive or not acupuncture intervention: * A mandatory acupuncture once a week if the patient' NRS global score at week 7 is ≥ 4 . * No acupuncture if the patient' NRS global score at week 7 is <4, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (11 listed)
- 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, nutritional deprivation, alcohol, diabetes, etc.),
- 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.
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture intervention6 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. | Other | Arm A |
| No acupunctureThe 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). | Other | Arm B |
Primary outcome
2-point improvement in the global NRS
Time frame: Week 7
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).
4 secondary outcomes
Numerical Rating Scale (NRS) score
Time frame: Week 7
Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire
Time frame: Assess at baseline, at week 7, 14, and at 6 months
Brief Pain Inventory (BPI) score
Time frame: Assess at baseline, at week 7, 14, and at 6 months
Peripheral sensory neuropathy grading scale
Time frame: Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuelle Kempf, MD principal investigator
Henri Mondor University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture intervention and No acupuncture in people with Colorectal Cancer and Liver Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Line GARCIA LARNICOL (0140298500, regulatory.affairs@gecor.com.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-point improvement in the global NRS (time frame: Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.