Acupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy (CIPN) in patients with early-stage colorectal cancer: A Feasibility, Effectiveness, and Safety Study

INTERVENTION: 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 CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Cancer ‐ Bowel ‐ Back passage (rectum) or large bowel (colon) Chemotherapy‐Induced Peripheral Neuropathy (CIPN); ; Chemotherapy‐Induced Peripheral Neuropathy (CIPN) Neurological ‐ Other neurological disorders PRIMARY OUTCOME: ; Effectiveness of acupuncture preventing CIPN (objective 2) [; Quantitative sensory testing (QST); Baseline, week 9,17, last cycle.; ] Effectiveness of acupuncture preventing CIPN (objective 2) [1. Patient Neurotoxicity Questionnaire (PNQ). ; ; ; ; From baseline, during chemotherapy at the cycle 3, 5, 7,9,11 and the last cycle and 4‐12 weeks after the last chemotherapy. (week1,5,9,13,17,21,24,28.); ] Feasibility of Acupuncture for Preventing CIPN (objective 1) [In three months : recruitment rate and application Completion rate as a composite outcome :; Recruitment rate will be calculated by comparing the number of participants enrolled in the study against the total number of eligible participants approached/invited to participate, per unit of time (patients/site/month) .; Application completion rate will be calculated as the number of participants who completed the application/PICF form divided by the number of participants who commenced the form( enrolled), expressed as a percentage.; ; How this data is collected: use one of the following methods to collect data:; ; 1. Verbally communicate face‐to‐face, data from the assessment test will be collected in paper format /digitally with the assistance of staff. Or ; ; 2. Provide you with a link to the online form, which you can complete digitally. Recruitment rate : timepoint ‐End of month 1, End of month 2, End of month 3 over three months of recruitment, assessment method through log form/screening form/ PICF form. ; ; Application Completion rate: timepoint ‐End of month 1, End of month 2, End of month 3 over three months ,assessment method through log form/ PICF form.; ] 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. Patien SECONDARY OUTCOME: Effectiveness of acupuncture preventing CIPN (objective 2) ‐Primary Outcome[3. Neuropathic pain assessment (LANSS). From baseline, during chemotherapy at the cycle 3, 5, 7,9,11 and the last cycle and 4‐12 weeks after the last chemotherapy. (week1,5,9,13,17,21,24,28.)] Effectiveness of acupuncture preventing CIPN (objective 2)‐ Primary Outcome[2. Functional Assessment of Cancer Therapy—Neurotoxicity subscale (FACT‐ NTX). From baseline, during chemotherapy at the cycle 3, 5, 7,9,11 and the last cycle and 4‐12 weeks after the last chemotherapy. (week1,5,9,13,17,21,24,28.)] Feasibility of Acupuncture for Preventing CIPN (objective 1)‐Primary Outcome[ Numbers of participants complete 70 % of scheduled acupuncture treatment through CRF form. Timepoint: baseline/enrollment,12‐17 week.] Feasibility of Acupuncture for Preventing CIPN (objective 1)‐Primary Outcome[Assessment method: Percentage of participants withdrawing from the study due to adverse events (AE)of the acupuncture treatment through CRF ( CASE REPORT FORM) in II Acupuncture section, PICF form: content form and withdraw form. Timepoint :baseline/enrollment, day of withdrawing due to AE in the study, ] Feasibility of Acupuncture for Preventing CIPN (objective 1)‐Primary Outcome[Number of participants withdrawing in the whole study through PICF form: content form and withdraw form. Timepoint: baseline/enrollment, day of withdrawing in the study] Feasibility of Acupuncture for Preventing CIPN (objective 1)‐Primary Outcome[Numbers of participants complete the whole acupuncture twenty‐four sessions for 24 weeks through CRF form. Timepoint: baseline/enrollment, week 24.] Safety of acupuncture for preventing CIPN (objective 3) [Adverse event of acupuncture: ; adverse event during /after acupuncture treatment/session ; Numbers of participants have adverse events ; Severity of the adverse event ; ; Possible adverse events such as pain, bleeding. ; How they will be assessed for adverse events : clinical examination/observation by acupuncturist according to study protocol, participant self‐reported. ; During /after acupuncture treatment / each session] Understand the experience and opinions of cancer participants(patients) and ; Healthcare practitioners (objective 4) ; [ ; The interviews can be conducted face‐to‐face at Northern Health Hospital or RMIT University in Bundoora, or via online by researcher Jennifer Liu. Each interview will take approximately 20 to 30 minutes. ; ; Participant 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). ; Data will be collected through recorded interviews. 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). ]