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

Summary

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.

Eligibility

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.

Conditions2

Locations1 site

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