None listed
Conditions
Brief summary
Brief description of the study purpose: This study aims to assess whether acupuncture is a practical, safe, and effective way to prevent nerve damage ( called chemotherapy induced peripheral neuropathy (CIPN)) in people receiving chemotherapy for early stage colorectal cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with early-stage colorectal cancer who have undergone surgery for the removal of colon cancer, and are planning to receive mFOLFOX chemotherapy, which can cause nerve damage (CIPN). Study details: This study is a randomized controlled trial at Northern Health Hospital in Melbourne. Participants will be randomly allocated to one of two groups in the trial: Acupuncture group: standard chemotherapy plus weekly acupuncture for 24 weeks. Each acupuncture session will last about 30 -45minutes (manual acupuncture or electroacupuncture). Needle retention time is 30 minutes. Participants will be monitored for nerve related symptoms from before starting chemotherapy until 28 weeks, using assessment and tests, which may include questionnaires and clinical evaluations. Another group: controlled group (standard care) with only mFOLFOX-6 chemotherapy, will be monitored and tested for symptom development from prior to chemotherapy to 28 weeks. After 24 weeks, participants in both groups may choose to receive acupuncture sessions voluntarily until week36. 15 participants of 30 participants and 6 health practitioners will be invited to be interviewed for sub-study face to face/online. The results of this research may help to shape future clinical guidelines for managing CIPN and cancer-related nerve pain in Australia and internationally, and improve supportive care for people undergoing chemotherapy.
Interventions
The project will design randomized clinical trial at Northern Health Hospital in Melbourne. Participants are diagnosed as early stage colorectal cancer. Participants are over 18 years old and plan to receive chemotherapy ( mFOLFOX) that may cause CIPN.
The study will conduct a randomized controlled trial with two arms: acupuncture group (15 participants) and controlled group without acupuncture (15 participants) at 1:1 Ratio. Acupuncture groups have one acupuncture treatment weekly for 24 wee
The project will design randomized clinical trial at Northern Health Hospital in Melbourne. Participants are diagnosed as early stage colorectal cancer. Participants are over 18 years old and plan to receive chemotherapy ( mFOLFOX) that may cause CIPN. The study will conduct a randomized controlled trial with two arms: acupuncture group (15 participants) and controlled group without acupuncture (15 participants) at 1:1 Ratio. Acupuncture groups have one acupuncture treatment weekly for 24 weeks. After 24 weeks, acupuncture will be voluntary to continue acupuncture treatment until week 36. The controlled group does not have acupuncture treatment for an initial 24 weeks, only undergoing assessment and testing. After 24 weeks, the controlled group can voluntarily begin acupuncture treatment for three months. 15 participants of 30 participants and 6 health practitioners will be invited to be interviewed for sub-study face to face/online. Acupuncturist: AHPRA-registered acupuncturist with more than 5 years’ experience with professional indemnity insurance. The acupuncturist will gently insert very fine needles into certain areas of your body following the protocol. Duration of the acupuncture sessions: • The needles typically stay in place for 20 to 30 minutes while the patient rests quietly. It is expected that each acupuncture treatment will take approximately 45 minutes to 1 hour. Treatments are done in a clean, comfortable setting, and all needles are single-use and disposable for your safety. What is involved during the acupuncture treatment: • Acupuncture treatment may involve either manual or electro acupuncture. The acupuncturist will assess each participant’s health condition to determine whether manual or electro acupuncture is most suitable. Based on this assessment, patients can choose their preferred approach (manual or electro), which will remain consistent throughout the whole trial unless there is a change in their condition. Electroacupuncture is a therapeutic technique in which a gentle electrical current (maximum output of 32 mA) is delivered through acupuncture needles using a medical device. In this study, the Acupuncture Stimulator (ES160) will be used, this device is an approved medical therapeutic device in Australia and is listed under entry 13763 (Stimulator) on the Australian Register of Therapeutic Goods (ARTG). Electroacupuncture has an established safety record and has been used in clinical practice for many years. Strategies used to assess or monitor adherence to the intervention: Metric tools: 1. Patient Neurotoxicity Questionnaire (PNQ). 2. Functional Assessment of Cancer Therapy—Neurotoxicity subscale (FACT- NTX). 3. Neuropathic pain assessment (LANSS). 4. Quantitative sensory testing (QST). How participants for the sub-study will be selected: 15 trial patients of 30 patients and 6 Health practitioners are interviewed (online or in-person) for sub-study. Sub-interview study: The sub-interview study will assess participants’ comfort and satisfaction throughout the entire study to evaluate the feasibility of acupuncture as a preventative approach for CIPN. The sub- interviews can be conducted face-to-face at Northern Health Hospital or RMIT University in Bundoora, or via online. Each interview will take approximately 20 to 30 minutes. Member of the research team in the project will interview participants. The Participants in sub-interview study will be required to attend a total of two interviews and complete one questionnaire form: the first interview during the enrolment, a second questionnaire will be filled out at week 13 (the midpoint of the study), and a final interview will take place at week 28 (the end of the study). Interview data will be digitally recorded including audio/video record. Participants' names will be coded to ensure confidentiality, and a summary of each interview will be sent to the participants for final confirmation. When the intervention occurs relative to chemotherapy treatment: Patients will receive one acupuncture session per week for 24 weeks (a total of 24 sessions). Acupuncture will be scheduled one day before each chemotherapy session. This is also the day patients usually have your blood test, so both can be done on the same day. The following week, acupuncture appointment will be on the same day as the previous week of acupuncture day. Example: If patient chemotherapy starts on a Wednesday (Cycle 1-day1), first acupuncture session will be on Tuesday that is blood test day, which helps patient reduces the travel burden. The following week, the acupuncture session will again be on Tuesday.
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility criteria: Patients from the hospital (Northern Health Hospital): Patients diagnosed with early-stage colorectal cancer who have undergone surgical intervention for the removal of their colon cancer, plan to receive adjuvant chemotherapy based on oxaliplatin. This treatment is administered through a regimen known as modified FOLFOX-6 (mFOLFOX-6). Inclusion Criteria: 1. Patients must be over 18 years old. 2. Patients are referred by oncologists to the trial at Northern Health Hospital. 3. Patients must be willing to commit to the clinical trial and stay in the trial for a duration of 24-36 weeks. They are required to sign the Participant Information and Consent Form (PICF), Which outlines the project details, including each treatment session lasting 30-45 minutes and involving manual acupuncture / electroacupuncture. Patients agree to receive documentation digitally, delivered by email or post. 4. Patients need to provide informed consent in English and complete study questionnaires in English. 5. Patients may have a medical history of diabetes but must not have peripheral neuropathy.
Exclusion criteria
Exclusion Criteria: 1.Patients are currently receiving chemotherapy or radiotherapy or have undergone tumor resection surgery in the past month. 2.Patients who have received chemotherapy with neuropathic agents like vinca alkaloids, bortezomib, or thalidomide in the past six months. 3. Local infection at or near the acupuncture site renders the patient unsuitable for acupuncture, as determined by a physician/ acupuncturist. Other factors, such as needle phobia, may also preclude a patient from receiving acupuncture treatment. 4.Patients use other alternative medicines such as herbal agents or high dose vitamins and minerals, as determined by a study doctor. 5.Patients have a low platelet count (below 50,000/µL) or low white blood cell count (below 3,000/µL) when screening participants. 6.The patients have active central nervous system (CNS) diseases such as multiple sclerosis. 7.The patients have severe heart disease/epilepsy. 8.Any patients have psychological or behavioral disorders, as determined by a study doctor. 9.The patients have previous acupuncture treatment for any indication before 30 days of enrolment. 10.The patient takes current medications that could affect symptoms related to CIPN. 11.Grade III lymphedema or more severe situations, such as systemic oedema arising from cardiogenic or nephrogenic disease. 12.Patients have pre-existing peripheral neuropathy. 13.Patients are allergic to nickel.
Outcome results
None listed