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Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study

RecruitingNAAges 18 Years - anyAllSidney Kimmel Comprehensive Cancer Center at Thom…
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In plain words

What the trial is, and whether it could suit you

The objective of the proposed pilot is to test the feasibility, acceptability, and preliminary efficacy of a 16-week sequential, multiple assessment randomized trial (SMART), which includes virtual Tai Chi/Qi Gong or α- Lipoic acid (ALA) supplements as an initial treatment, and acupuncture as the additional treatment, that examines a stepped-care intervention to address CIPN.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study: * Age 18 years or older, * Self-reported moderate (≥ 2/4) numbness and tingling on the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Numbness and Tingling Severity Item in the previous week, * At least three months since the last receipt of neurotoxic chemotherapy, * Prior receipt of paclitaxel, docetaxel, cisplatin, oxaliplatin, nab-paclitaxel, or carboplatin for the treatment of stage I-III Gastrointestinal (GI) cancers, * Speaking/reading English. Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Prognosis of ≤ 3 months, * Documented neuropathy attributed to other causes (e.g., diabetic neuropathy), * Intention to initiate a new prescription of duloxetine or other pain medications (i.e., first-line treatment for CIPN pain) during the study period; however, participants may continue on duloxetine or other pain medications if initiated at least 8 weeks before study enrollment, with no change in dose, and reporting unmanaged CIPN (i.e., ≥ 2/4) PRO-CTCAE numbness/tingling severity in the last week, * Currently using alcohol (ethyl), which means regular alcohol consumption (defined as ≥7 drinks/week for women, ≥14 drinks/week for men, or binge drinking \>3 drinks per occasion at least weekly) within the past 3 months, or current alcohol use disorder or inability/unwillingness to abstain from alcohol during the study intervention period, * Currently using calcium salts, iron preparations or magnesium salts orally, * With thyroid disorders, particularly those with hypo- or hyperthyroidism, * With thiamine deficiency, as assessed and verified by the physician.
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What it tests

  • Tai Chi/Qi Gong
  • α- Lipoic acid
  • Acupuncture
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Where

1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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