Integrative Medicine for Chemotherapy-Induced Peripheral Neuropathy

August 21, 2024 updated by: Noah Samuels, The Chaim Sheba Medical Center

Impact of Integrative Medicine on Chemotherapy-Induced Peripheral Neuropathy: A Multi-centered, Randomized Controlled Trial

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often debilitating complication of cancer treatments. There is presently no known treatment which can prevent the onset of CIPN, with treatment of existing symptoms limited to reducing the dose intensity of the offending agent. Clinical research has shown that complementary/integrative medicine (CIM) modalities such as acupuncture and reflexology may be effective in relieving CIPN-related symptoms. The present study will included 120 patients suffering from CIPN-related symptoms, and will take place at 3 medical centers in Israel which provide CIM treatments to oncology and hemato-oncology patients. Participants will be allocated to either the control arm (standard conventional supportive care; n=40) or to the intervention arm of the study (standard care with CIM treatments; n=80), based on their preference. Patients in the treatment arm of the study will be randomly allocated to either twice-weekly, single modality acupuncture treatments (n=40), or to a multi-modality treatment program (n=40), which will include acupuncture and additional CIM modalities (i.e., manual-movement and mind-body therapies), for a 6-week period.

The effect of CIM treatments in reducing the severity of CIPN-related symptoms will be assessed at baseline and at 6- and 9-week follow-up visits, using the Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool; the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30); and the Measure Yourself Concerns and Well-being (MYCAW) questionnaire. Interim assessment of symptom severity will be conducted by the study nurse throughout the study period, through either telephone or e-mail. Additional study outcomes will include the safety of the CIM treatments; QOL-related concerns which may affect CIPN-related symptoms (e.g., anxiety, depression, sleep disturbances, etc.), as well as issues related to body image and coping with CIPN; physiological assessment of CIPN using a von Frey test (with hairs of varying diameters to assess the threshold for touch evoked sensations); and adherence to the planned oncology treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Chaim Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients with breast or gynecological cancers who are undergoing a treatment regimen which includes taxane-based chemotherapy (e.g., Paclitaxel, Docetaxel); or
  • Patients of either gender with hematological malignancies who are undergoing a treatment regimen which includes neuropathy-inducing agents (e.g., bortezumab for multiple myeloma, etc.).
  • Eligible patients will report altered sensations and/or pain in the areas of the feet and or hands, with a score of ≥ 2 (moderate-to-severe) for chemotherapy-induced peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events - version 4.0 (CTC-AE.v-4.0)
  • The onset of CIPN-related symptoms must be recent, following a recently-administered course of chemotherapy and with symptoms appearing no more than a month prior to study recruitment.

Patients must be able to comply with the study protocol, which includes weekly follow-up visits, either in person or by phone; completion of the study questionnaires, in accordance with the study protocol; and, for patients in the treatment arm of the study, attending twice-weekly CIM treatment sessions.

Exclusion Criteria:

- Patients not fulfilling the inclusion criteria, or those with a history of chronic medical conditions which predispose to the development of CIPN (e.g., diabetes mellitus, alcohol abuse), will be ineligible for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
The control group will consist of patients who choose not to undergo CIM treatments for their CIPN-related symptoms. Participants in this arm of the study will receive standard conventional supportive care, as provided by their oncology health care professionals (HCPs), and closely monitored for any changes in the severity of their CIPN-related symptoms.
Active Comparator: Intervention Group A: Single Modality (acupuncture)
Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture x2/week, for 6 weeks.
Other: Acupuncture

Acupuncture treatments will be patient-tailored, with the acupuncture points (acu-points) to be selected by the acupuncturist at each treatment session, in accordance with the dynamic of the patient's symptoms, concerns and expectations. At the same time, acupuncturists will be required to choose at least 5 of the following 11 acupoints, which are to be incorporated into their treatment regimen:

Lower limb points: Liver (LIV) 3, Spleen (SP) 4, SP6, Stomach (ST) 36, Gallbladder (GB) 34, Kidney (KID) 3, LIV8, Web (Bafeng) points Upper limb points: Large Intestine (LI) 4, LI 11, LI10, Pericardium (PC) 6, Triple Warmer (TW) 3/4/5
Active Comparator: Intervention Group B: Multi-modality (acupuncture "plus")
Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture with additional CIM treatment modalities, x2/week, for 6 weeks.
Other: Acupuncture

Acupuncture treatments will be patient-tailored, with the acupuncture points (acu-points) to be selected by the acupuncturist at each treatment session, in accordance with the dynamic of the patient's symptoms, concerns and expectations. At the same time, acupuncturists will be required to choose at least 5 of the following 11 acupoints, which are to be incorporated into their treatment regimen:

Lower limb points: Liver (LIV) 3, Spleen (SP) 4, SP6, Stomach (ST) 36, Gallbladder (GB) 34, Kidney (KID) 3, LIV8, Web (Bafeng) points Upper limb points: Large Intestine (LI) 4, LI 11, LI10, Pericardium (PC) 6, Triple Warmer (TW) 3/4/5

Other: Multi-modality (Acupuncture "plus")

A number of additional CIM treatment modalities will be added to the acupuncture treatment in this arm of the study, in accordance with the practitioners available at each of the participating study centers. These will include one of more of the following:

  • Manual-movement therapies - e.g. acupressure/reflexology, self- and caregiver-practiced acupressure
  • Mind-body therapies - e.g. relaxation/imagery method, Anthroposophic music therapy The multimodal CIM treatment regimen will be re-evaluated at each session, and adapted according to the concerns and expectations of the patients, as well as the recommendation of the treating CIM practitioner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptom Severity(neuropathy): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool
Time Frame: Up to 9 weeks
CIPN-related symptoms
Up to 9 weeks
Symptom Severity(neuropathy): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame: Up to 9 weeks
CIPN-related symptoms
Up to 9 weeks
Symptom Severity(neuropathy): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:
Time Frame: Up to 9 weeks
CIPN-related symptoms
Up to 9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptom Severity(additional concerns): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool
Time Frame: Up to 9 weeks
Additional QOL-related concerns
Up to 9 weeks
Symptom Severity(additional concerns): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame: Up to 9 weeks
Additional QOL-related concerns
Up to 9 weeks
Symptom Severity(additional concerns): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:
Time Frame: Up to 9 weeks
Additional QOL-related concerns
Up to 9 weeks
Symptom Severity(neuropathy): Physiological Assessment of CIPN Severity
Time Frame: Up to 9 weeks
The von Frey test (Semmes Weinstein Monofilament Set, Bioseb In Vivo Research Instruments, France/USA).
Up to 9 weeks
Adherence to Chemotherapy Regimen: Relative Dose Intensity (RDI)
Time Frame: After 9 weeks
RDI = Dose Administered (mg) / Interval between treatments (days) ÷ Planned Dose (mg) / Planned Interval between treatments (days)
After 9 weeks
Adverse Effects Associated with CIM treatments
Time Frame: After 9 weeks
Registering of any adverse events believed to be related to the study intervention treatments
After 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Chaim Sheba Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bnai Zion Medical Center
Carmel Medical Center
Lin Medical Center, Haifa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elad Schiff, MD, Bnai Zion Medical Center, Haifa
  • Principal Investigator: Eran Ben-Arye, MD, Lin Medical Center, Haifa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4462-17-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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