Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study
Recruiting
N/AInterventional Study
Peripheral Neuropathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
60 (estimated)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Other
Who this trial is looking for
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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.
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Eligibility Criteria
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 …
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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