Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients - Clinical Trial for Colorectal Cancer | NCT05850130

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Acupuncture intervention

No acupuncture

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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), 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), Exclusion Criteria 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, 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.

Sites / Locations

Centre intercommunal de Créteil
Hôpital Henri Mondor
Institu Daniel Hollard
Hôpital Pitié Salpêtrière
Hôpital Saint Antoine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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.

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,

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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).

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.

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.

Full Information

NCT ID

NCT05850130

First Posted

April 28, 2023

Last Updated

June 28, 2023

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

1. Study Identification

Unique Protocol Identification Number

NCT05850130

Brief Title

Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients

Acronym

ACUPOX

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

October 2026 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Liver Cancer, Gastric Cancer, Pancreas Cancer, Esophagus Cancer

Keywords

acupuncture

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

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,

Intervention Type

Other

Intervention Name(s)

Acupuncture intervention

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.

Intervention Type

Other

Intervention Name(s)

No acupuncture

Intervention 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).

Primary Outcome Measure Information:

Title

2-point improvement in the global NRS

Description

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).

Time Frame

Week 7

Secondary Outcome Measure Information:

Title

Numerical Rating Scale (NRS) score

Description

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.

Time Frame

Week 7

Title

Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire

Description

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).

Time Frame

Assess at baseline, at week 7, 14, and at 6 months

Title

Brief Pain Inventory (BPI) score

Description

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.

Time Frame

Assess at baseline, at week 7, 14, and at 6 months

Title

Peripheral sensory neuropathy grading scale

Description

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.

Time Frame

Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion 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), 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), Exclusion Criteria 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, 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Line GARCIA LARNICOL

Phone

0140298500

Email

regulatory.affairs@gecor.com.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emmanuelle Kempf, MD

Organizational Affiliation

Henri Mondor University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre intercommunal de Créteil

City

Créteil

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle COJEAN ZELEK, MD

First Name & Middle Initial & Last Name & Degree

Isabelle COJEAN ZELEK, MD

Facility Name

Hôpital Henri Mondor

City

Créteil

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

emmanuelle KEMPF, MD

First Name & Middle Initial & Last Name & Degree

Emmanuelle KEMPF, MD

Facility Name

Institu Daniel Hollard

City

Grenoble

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Camille HERVE, MD

First Name & Middle Initial & Last Name & Degree

Camille HERVE, MD

Facility Name

Hôpital Pitié Salpêtrière

City

Paris

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Baptiste BACHET, MD

First Name & Middle Initial & Last Name & Degree

Jean Baptiste BACHET, MD

Facility Name

Hôpital Saint Antoine

City

Paris

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hélène BOUSSION, MD

First Name & Middle Initial & Last Name & Degree

Hélène BOUSSION, MD

Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients (ACUPOX)

Colorectal Cancer, Liver Cancer, Gastric Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial