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
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAcupuncture Therapy
Undergo acupuncture
PROCEDUREAcupressure Therapy
Undergo acupressure
PROCEDUREOral Cryotherapy
Undergo oral cryotherapy
OTHERQuestionnaire Administration
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
University of Washington
National Cancer Institute (NCI)
The Safeway Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months | At 3 months | Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy | 3 months | Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate. |
| Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure | 3 months | The Neuropen is used to assess pressure perception. Pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot at each of the ten different sites recorded as present or absent. The proportion present was calculated for each patient at baseline and at 3 months. The difference between these proportions from baseline to 3 months was calculated for each patient. The mean of these differences was calculated within each arm and the difference of those means was then compared between arms. |
| Severity of CIPN: Tuning Fork Vibration Sensation Testing | 3 months | A study-specific 128-Hz tuning fork will be used to assess vibration sensation on the great toe at baseline and 3 months. The time in seconds to loss of vibration sensation was measured. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN. The difference from baseline to 3 months in number of seconds to loss of vibration sensation was calculated for each patient. The differences were averaged across patients in each arm. The mean differences were compared between arms. |
| Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments | 3 months | Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted. |
| Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months | 3 months | Measured by patient-reported National Cancer Institute \[NCI\] Patient Reported Outcomes \[PRO\]-CTCAE. The change in severity from baseline to 3 months was calculated and it ranged from -3 to 3. The severity was measured on a 0-3 (0=None, 3=Severe) scale with a higher value representing a worse outcome and a lower value representing a better outcome. This was done separately for pain, fatigue, nausea, and anxiety. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStacey Cohen
Fred Hutch/University of Washington Cancer Consortium
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire Autonomic | 42.1 units on a scale STANDARD_DEVIATION 15.1 |
| European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire Motor | 36.8 units on a scale STANDARD_DEVIATION 6.6 |
| European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire Sensory | 35.8 units on a scale STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 33 | 3 / 36 |
| other Total, other adverse events | 18 / 33 | 26 / 36 |
| serious Total, serious adverse events | 0 / 33 | 0 / 36 |
Outcome results
None listed