Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07501663

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

Led by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Updated on 2026-04-14

60

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Moderate or greater numbness and tingling (≥ 2/4) reported in the last week
  • At least three months since last neurotoxic chemotherapy treatment
  • Prior chemotherapy with paclitaxel, docetaxel, cisplatin, oxaliplatin, nab-paclitaxel, or carboplatin for stage I-III gastrointestinal cancers
  • Ability to read and speak English
Not Eligible

You will not qualify if you...

  • Life expectancy of 3 months or less
  • Neuropathy caused by other conditions like diabetes
  • Planning to start new duloxetine or other pain medications during the study
  • Regular alcohol use as defined (≥7 drinks/week women, ≥14 drinks/week men) or alcohol use disorder
  • Current use of oral calcium, iron, or magnesium supplements
  • Having thyroid disorders such as hypo- or hyperthyroidism
  • Diagnosed thiamine deficiency confirmed by a physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

K

Kuang-Yi Wen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

6

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