Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Appendix Carcinoma Colon Carcinoma Esophageal Carcinoma Gastric Carcinoma Liver and Intrahepatic Bile Duct Carcinoma Malignant Digestive System Neoplasm Pancreatic Carcinoma Rectal Carcinoma Small Intestinal Carcinoma Anal Carcinoma Digestive System Carcinoma Digestive System Neuroendocrine Tumor Pancreatic Neuroendocrine Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (acupuncture, acupressure, cryotherapy)

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.

Group Type EXPERIMENTAL

Acupuncture Therapy

Intervention Type PROCEDURE

Undergo acupuncture

Acupressure Therapy

Intervention Type PROCEDURE

Undergo acupressure

Oral Cryotherapy

Intervention Type PROCEDURE

Undergo oral cryotherapy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm II (cryotherapy)

Patients undergo standard of care oral cryotherapy.

Group Type ACTIVE_COMPARATOR

Oral Cryotherapy

Intervention Type PROCEDURE

Undergo oral cryotherapy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Acupuncture Therapy

Undergo acupuncture

Intervention Type PROCEDURE

Acupressure Therapy

Undergo acupressure

Intervention Type PROCEDURE

Oral Cryotherapy

Undergo oral cryotherapy

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Acupuncture acupressure Ischemic Compression Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* GI cancer (primary esophagus, gastric, pancreas, biliary, liver, small bowel, appendix, colon, rectal, anal, or gastrointestinal/pancreatic neuroendocrine tumor) scheduled to receive a new start of fluorouracil (5-FU), oxaliplatin, +/- irinotecan (fluorouracil/leucovorin calcium/oxaliplatin \[FOLFOX\], fluorouracil/irinotecan/leucovorin calcium/oxaliplatin \[FOLFIRINOX\], leucovorin/fluorouracil/oxaliplatin/irinotecan \[FOLFOXIRI\] regimens) with plan for \>= 3 months of therapy with the regimen. Chemotherapy can be given for neoadjuvant, adjuvant, or palliative intent. 1 dose (cycle) of the intended regimen is permitted prior to study enrollment.

\*\*There is no limitation on the addition of a biologic agent to one of the above chemotherapy regimens, including, but not limited to: bevacizumab, cetuximab, panitumumab, trastuzumab, or the biosimilars of these agents
* Age \>=18 years
* Absolute neutrophil count \> 0.5 thousand/microL
* Platelet count \> 20 thousand/microL
* Not currently pregnant
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

* Baseline peripheral neuropathy from any cause
* Planned oxaliplatin with capecitabine
* Planned initial dose of oxaliplatin \< 100% of the standard regimen-specified dose. For most regimens, this would be 85 mg/m\^2 intravenously (IV) dosed every 14 days
* Receipt of acupuncture treatment in the prior 3 months
* Use of concomitant duloxetine for minimization of neuropathy
* Psychiatric illness/social situations that would limit compliance with study requirements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No