This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04505553.
PRIMARY OBJECTIVE:
I. To evaluate the severity of chemotherapy-induced peripheral neuropathy (CIPN) in gastrointestinal (GI) cancer patients receiving oxaliplatin-based chemotherapy following 3 months of acupuncture/acupressure treatment plus oral cryotherapy compared to oral cryotherapy alone.
SECONDARY OBJECTIVES:
I. To estimate the incidence of grade 2 or higher CIPN following 3 months of acupuncture/acupressure treatment plus oral cryotherapy compared to oral cryotherapy alone.
II. To evaluate the severity of CIPN in GI cancer patients receiving oxaliplatin-based chemotherapy following 3 months of acupuncture/acupressure treatment plus oral cryotherapy compared to oral cryotherapy alone using objective measurement tools.
III. To assess the feasibility of delivering acupuncture during biweekly chemotherapy infusion and the feasibility of patient self-administered acupressure between infusions.
IV. To evaluate the effect of oral cryotherapy with acupuncture/acupressure versus (vs.) oral cryotherapy alone in reducing pain, fatigue, nausea, oral dysesthesia, and anxiety in GI cancer patients receiving oxaliplatin-based chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.
ARM II: Patients undergo standard of care oral cryotherapy.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorStacey A. Cohen
