Trial Outcomes & Findings for Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer (NCT NCT04505553)

Last Updated: 2026-01-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

At 3 months

Results posted on

2026-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Overall Study STARTED	37	41
Overall Study COMPLETED	33	36
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Acupuncture, Acupressure, Cryotherapy) n=33 Participants 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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) n=36 Participants Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=37 Participants	36 Participants n=44 Participants	68 Participants n=40 Participants
Age, Categorical >=65 years	1 Participants n=37 Participants	0 Participants n=44 Participants	1 Participants n=40 Participants
Sex: Female, Male Female	20 Participants n=37 Participants	15 Participants n=44 Participants	35 Participants n=40 Participants
Sex: Female, Male Male	13 Participants n=37 Participants	21 Participants n=44 Participants	34 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=37 Participants	3 Participants n=44 Participants	3 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=37 Participants	29 Participants n=44 Participants	60 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=37 Participants	4 Participants n=44 Participants	6 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=37 Participants	1 Participants n=44 Participants	2 Participants n=40 Participants
Race (NIH/OMB) Asian	5 Participants n=37 Participants	5 Participants n=44 Participants	10 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=37 Participants	0 Participants n=44 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants	1 Participants n=44 Participants	2 Participants n=40 Participants
Race (NIH/OMB) White	24 Participants n=37 Participants	26 Participants n=44 Participants	50 Participants n=40 Participants
Race (NIH/OMB) More than one race	1 Participants n=37 Participants	0 Participants n=44 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	3 Participants n=44 Participants	3 Participants n=40 Participants
Region of Enrollment United States	33 participants n=37 Participants	36 participants n=44 Participants	69 participants n=40 Participants
European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire Sensory	35 units on a scale STANDARD_DEVIATION 3.7 • n=37 Participants	36.4 units on a scale STANDARD_DEVIATION 4.5 • n=44 Participants	35.8 units on a scale STANDARD_DEVIATION 4.2 • n=40 Participants
European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire Motor	36.5 units on a scale STANDARD_DEVIATION 5.9 • n=37 Participants	36.8 units on a scale STANDARD_DEVIATION 6.6 • n=44 Participants	36.6 units on a scale STANDARD_DEVIATION 6.2 • n=40 Participants
European Organisation For Research & Treatment of Cancer-CIPN 20 questionnaire Autonomic	37.8 units on a scale STANDARD_DEVIATION 11.6 • n=37 Participants	45.3 units on a scale STANDARD_DEVIATION 16.7 • n=44 Participants	42.1 units on a scale STANDARD_DEVIATION 15.1 • n=40 Participants

PRIMARY outcome

Timeframe: At 3 months

Population: Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.

Outcome measures

Outcome measures
Measure	Arm I (Acupuncture, Acupressure, Cryotherapy) n=20 Participants 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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) n=27 Participants Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months Sensory Subscale	5.9 units on a scale Interval -7.4 to 37.0	9.1 units on a scale Interval -11.1 to 25.9
Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months Motor Subscale	1.9 units on a scale Interval -16.7 to 12.5	5.7 units on a scale Interval -4.2 to 25.0
Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months Autonomic Subscale	0.6 units on a scale Interval -33.3 to 22.2	0.8 units on a scale Interval -50.0 to 44.4

SECONDARY outcome

Timeframe: 3 months

Population: Frequency of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

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.

Outcome measures

Outcome measures
Measure	Arm I (Acupuncture, Acupressure, Cryotherapy) n=33 Participants 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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) n=36 Participants Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy No Peripheral Sensory Neuropathy	28 Participants	33 Participants
Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy Peripheral Sensory Neuropathy	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study.

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.

Outcome measures

Outcome measures
Measure	Arm I (Acupuncture, Acupressure, Cryotherapy) n=21 Participants 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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) n=27 Participants Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure	-1.0 proportion of present responses Standard Deviation 4.4	-0.7 proportion of present responses Standard Deviation 7.3

SECONDARY outcome

Timeframe: 3 months

Population: Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study.

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.

Outcome measures

Outcome measures
Measure	Arm I (Acupuncture, Acupressure, Cryotherapy) n=21 Participants 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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) n=27 Participants Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Severity of CIPN: Tuning Fork Vibration Sensation Testing	-5.0 seconds Standard Deviation 11.6	0.1 seconds Standard Deviation 6.6

SECONDARY outcome

Timeframe: 3 months

Population: Summary of Patient Adherence to Acupuncture Protocol Based on 60% Threshold

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.

Outcome measures

Outcome measures
Measure	Arm I (Acupuncture, Acupressure, Cryotherapy) n=33 Participants 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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments Adherent	23 Participants	—
Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments Nonadherent	10 Participants	—

SECONDARY outcome

Timeframe: 3 months

Population: Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.

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.

Outcome measures

Outcome measures
Measure	Arm I (Acupuncture, Acupressure, Cryotherapy) n=20 Participants 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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) n=27 Participants Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months Nausea	-0.3 units on a scale Standard Deviation 0.7	0.3 units on a scale Standard Deviation 1.0
Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months Pain	-0.3 units on a scale Standard Deviation 1.2	-0.3 units on a scale Standard Deviation 1.1
Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months Fatigue	-0.1 units on a scale Standard Deviation 0.9	0.4 units on a scale Standard Deviation 1.2
Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months Anxiety	-0.1 units on a scale Standard Deviation 1.0	-0.1 units on a scale Standard Deviation 0.9

Adverse Events

Arm I (Acupuncture, Acupressure, Cryotherapy)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 5 deaths

Arm II (Cryotherapy)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I (Acupuncture, Acupressure, Cryotherapy) n=33 participants at risk 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. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies	Arm II (Cryotherapy) n=36 participants at risk Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Gastrointestinal disorders Constipation	42.4% 14/33 • 22 weeks CTCAE vr. 5 terms used	36.1% 13/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Diarrhea	24.2% 8/33 • 22 weeks CTCAE vr. 5 terms used	44.4% 16/36 • 22 weeks CTCAE vr. 5 terms used
Nervous system disorders Dizziness	0.00% 0/33 • 22 weeks CTCAE vr. 5 terms used	13.9% 5/36 • 22 weeks CTCAE vr. 5 terms used
Respiratory, thoracic and mediastinal disorders Dyspnea	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	13.9% 5/36 • 22 weeks CTCAE vr. 5 terms used
General disorders Edema Limbs	0.00% 0/33 • 22 weeks CTCAE vr. 5 terms used	11.1% 4/36 • 22 weeks CTCAE vr. 5 terms used
Respiratory, thoracic and mediastinal disorders Epistaxis	12.1% 4/33 • 22 weeks CTCAE vr. 5 terms used	11.1% 4/36 • 22 weeks CTCAE vr. 5 terms used
Eye disorders Eye Pain	0.00% 0/33 • 22 weeks CTCAE vr. 5 terms used	8.3% 3/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Gastroesophageal Reflux Disease	9.1% 3/33 • 22 weeks CTCAE vr. 5 terms used	5.6% 2/36 • 22 weeks CTCAE vr. 5 terms used
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/33 • 22 weeks CTCAE vr. 5 terms used	5.6% 2/36 • 22 weeks CTCAE vr. 5 terms used
Vascular disorders Hot Flashes	0.00% 0/33 • 22 weeks CTCAE vr. 5 terms used	5.6% 2/36 • 22 weeks CTCAE vr. 5 terms used
Metabolism and nutrition disorders Hypokalemia	3.0% 1/33 • 22 weeks CTCAE vr. 5 terms used	8.3% 3/36 • 22 weeks CTCAE vr. 5 terms used
Nervous system disorders Paresthesia	21.2% 7/33 • 22 weeks CTCAE vr. 5 terms used	33.3% 12/36 • 22 weeks CTCAE vr. 5 terms used
Nervous system disorders Peripheral Motor Neuropathy	3.0% 1/33 • 22 weeks CTCAE vr. 5 terms used	8.3% 3/36 • 22 weeks CTCAE vr. 5 terms used
Nervous system disorders Peripheral Sensory Neuropathy	54.5% 18/33 • 22 weeks CTCAE vr. 5 terms used	55.6% 20/36 • 22 weeks CTCAE vr. 5 terms used
Skin and subcutaneous tissue disorders Rash Acneiform	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	8.3% 3/36 • 22 weeks CTCAE vr. 5 terms used
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.0% 1/33 • 22 weeks CTCAE vr. 5 terms used	5.6% 2/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/33 • 22 weeks CTCAE vr. 5 terms used	5.6% 2/36 • 22 weeks CTCAE vr. 5 terms used
Surgical and medical procedures Other Surgical and Medical Procedures	0.00% 0/33 • 22 weeks CTCAE vr. 5 terms used	5.6% 2/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Vomiting	24.2% 8/33 • 22 weeks CTCAE vr. 5 terms used	25.0% 9/36 • 22 weeks CTCAE vr. 5 terms used
Psychiatric disorders Confusion	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	0.00% 0/36 • 22 weeks CTCAE vr. 5 terms used
Investigations Aspartate Aminotransferase Increased	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	0.00% 0/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Dyspepsia	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	2.8% 1/36 • 22 weeks CTCAE vr. 5 terms used
Renal and urinary disorders Dysuria	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	2.8% 1/36 • 22 weeks CTCAE vr. 5 terms used
Respiratory, thoracic and mediastinal disorders Hoarseness	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	2.8% 1/36 • 22 weeks CTCAE vr. 5 terms used
Psychiatric disorders Insomnia	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	2.8% 1/36 • 22 weeks CTCAE vr. 5 terms used
Investigations Neutrophil Count Decreased	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	0.00% 0/36 • 22 weeks CTCAE vr. 5 terms used
Investigations Platelet Count Decreased	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	0.00% 0/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Rectal Hemorrhage	9.1% 3/33 • 22 weeks CTCAE vr. 5 terms used	2.8% 1/36 • 22 weeks CTCAE vr. 5 terms used
Respiratory, thoracic and mediastinal disorders Sore Throat	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	0.00% 0/36 • 22 weeks CTCAE vr. 5 terms used
Infections and infestations Upper Respiratory Infection	9.1% 3/33 • 22 weeks CTCAE vr. 5 terms used	0.00% 0/36 • 22 weeks CTCAE vr. 5 terms used
Skin and subcutaneous tissue disorders Urticaria	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	0.00% 0/36 • 22 weeks CTCAE vr. 5 terms used
Investigations White Blood Cell Decreased	12.1% 4/33 • 22 weeks CTCAE vr. 5 terms used	2.8% 1/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Nausea	51.5% 17/33 • 22 weeks CTCAE vr. 5 terms used	61.1% 22/36 • 22 weeks CTCAE vr. 5 terms used
General disorders Fatigue	45.5% 15/33 • 22 weeks CTCAE vr. 5 terms used	72.2% 26/36 • 22 weeks CTCAE vr. 5 terms used
Psychiatric disorders Anxiety	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	0.00% 0/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Oral Symptoms	21.2% 7/33 • 22 weeks CTCAE vr. 5 terms used	22.2% 8/36 • 22 weeks CTCAE vr. 5 terms used
Gastrointestinal disorders Abdominal Pain	15.2% 5/33 • 22 weeks CTCAE vr. 5 terms used	27.8% 10/36 • 22 weeks CTCAE vr. 5 terms used
Musculoskeletal and connective tissue disorders Other Body Pain	3.0% 1/33 • 22 weeks CTCAE vr. 5 terms used	19.4% 7/36 • 22 weeks CTCAE vr. 5 terms used
Nervous system disorders Dysgeusia	12.1% 4/33 • 22 weeks CTCAE vr. 5 terms used	13.9% 5/36 • 22 weeks CTCAE vr. 5 terms used
Nervous system disorders Headache	3.0% 1/33 • 22 weeks CTCAE vr. 5 terms used	8.3% 3/36 • 22 weeks CTCAE vr. 5 terms used
Nervous system disorders Dysarthria	12.1% 4/33 • 22 weeks CTCAE vr. 5 terms used	2.8% 1/36 • 22 weeks CTCAE vr. 5 terms used
Skin and subcutaneous tissue disorders Alopecia	6.1% 2/33 • 22 weeks CTCAE vr. 5 terms used	5.6% 2/36 • 22 weeks CTCAE vr. 5 terms used
Blood and lymphatic system disorders Anemia	12.1% 4/33 • 22 weeks CTCAE vr. 5 terms used	11.1% 4/36 • 22 weeks CTCAE vr. 5 terms used
Metabolism and nutrition disorders Anorexia	3.0% 1/33 • 22 weeks CTCAE vr. 5 terms used	22.2% 8/36 • 22 weeks CTCAE vr. 5 terms used
Eye disorders Blurred Vision	3.0% 1/33 • 22 weeks CTCAE vr. 5 terms used	5.6% 2/36 • 22 weeks CTCAE vr. 5 terms used

Additional Information

Stacey Cohen, MD

University of Washington Medical Center - Montlake

Phone: 2066066405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place