This clinical trial tests the feasibility of Tai Chi/Qi Gong or alpha lipoic acid with or without acupuncture for the treatment of chemotherapy induced peripheral neuropathy (CIPN) for patients with stage I-III colorectal cancer. CIPN is characterized by persistent numbness, tingling, and pain in the hands and feet and is a common side effect among colorectal cancer patients. Tai Chi/Qi Gong, a weight-bearing mind-body movement therapy incorporating deep breathing exercises and slow, coordinated movements, has shown significant reductions in peripheral neuropathy among participants. Alpha lipoic acid is an antioxidant supplement that has shown to help in the management of diabetes-induced neuropathy, and therefore may be effective for CIPN. Acupuncture is the practice of piercing specific points on the body with very thin sterile needles in order to relieve pain or other symptoms. Tai Chi/Qi Gong or alpha lipoic acid with or without acupuncture may be feasible for treating CIPN in patients with stage I-III colorectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07501663.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Thomas Jefferson University HospitalStatus: Active
Contact: Kuang-Yi Wen
Phone: 215-503-4623
PRIMARY OBJECTIVE:
I. To examine the feasibility of the patient accrual, diversity, adherence, and the sequential, multiple assessment randomized trial (SMART) design.
SECONDARY OBJECTIVE:
I. To examine the acceptability of the SMART interventions.
EXPLORATORY OBJECTIVE:
I. To explore the effects of the six treatment sequences embedded in the SMART on improvement in CIPN at 16 week follow up.
OUTLINE:
PART 1: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend Tai Chi/Qi Gong classes virtually, over 1 hour, twice weekly (BIW) for 8 weeks. Classes emphasize mindfulness, posture alignment, natural breathing, active relaxation, slow movement and integrated movement. Patients then undergo follow up assessment. Patients with a sufficient response continue treatment for an additional 8 weeks. Patients with an insufficient response are assigned to part 2.
ARM II: Patients receive alpha lipoic acid orally (PO) once daily (QD) for 8 weeks in the absence of unacceptable toxicity. Patients then undergo follow up assessment. Patients with a sufficient response continue treatment for an additional 8 weeks. Patients with an insufficient response are assigned to part 2.
PART 2: Patients from Arm I are randomized to Arm III or IV. Patients from Arm II are randomized to Arm III or V.
ARM III: Patients attend Tai Chi/Qi Gong classes virtually, over 1 hour, BIW for 8 weeks. Classes emphasize mindfulness, posture alignment, natural breathing, active relaxation, slow movement and integrated movement. Patients also receive alpha lipoic acid PO QD for 8 weeks in the absence of unacceptable toxicity.
ARM IV: Patients attend Tai Chi/Qi Gong classes virtually, over 1 hour, BIW for 8 weeks. Classes emphasize mindfulness, posture alignment, natural breathing, active relaxation, slow movement and integrated movement. Patients also receive acupuncture treatment, over 30 minutes, once weekly (QW) for 8 weeks in the absence of unacceptable toxicity.
ARM V: Patients receive alpha lipoic acid PO QD for 8 weeks in the absence of unacceptable toxicity. Patients also receive acupuncture treatment, over 30 minutes, QW for 8 weeks in the absence of unacceptable toxicity.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorKuang-Yi Wen
