An interventional study of Acupuncture and Multi-modality (Acupuncture "plus") in Chemotherapy-induced Peripheral Neuropathy, sponsored by The Chaim Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by The Chaim Sheba Medical Center · Not applicable, Interventional, and Treatment
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.
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:
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.
Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture x2/week, for 6 weeks.
Other: Acupuncture
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 · Other: Multi-modality (Acupuncture "plus")
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
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.
Symptom Severity(neuropathy): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool
CIPN-related symptoms
Time frame: Up to 9 weeks
Symptom Severity(neuropathy): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
CIPN-related symptoms
Time frame: Up to 9 weeks
Symptom Severity(neuropathy): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:
CIPN-related symptoms
Time frame: Up to 9 weeks
Symptom Severity(additional concerns): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool
Additional QOL-related concerns
Time frame: Up to 9 weeks
Symptom Severity(additional concerns): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Additional QOL-related concerns
Time frame: Up to 9 weeks
Symptom Severity(additional concerns): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:
Additional QOL-related concerns
Time frame: Up to 9 weeks
Symptom Severity(neuropathy): Physiological Assessment of CIPN Severity
The von Frey test (Semmes Weinstein Monofilament Set, Bioseb In Vivo Research Instruments, France/USA).
Time frame: Up to 9 weeks
Adherence to Chemotherapy Regimen: Relative Dose Intensity (RDI)
RDI = Dose Administered (mg) / Interval between treatments (days) ÷ Planned Dose (mg) / Planned Interval between treatments (days)
Time frame: After 9 weeks
Adverse Effects Associated with CIM treatments
Registering of any adverse events believed to be related to the study intervention treatments
Time frame: After 9 weeks
Plan to share: No
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