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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

About this trial

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 criteria

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.