NCT04505553 · ADVERSE EVENTS

Adverse events

Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer · Source last updated 2026-01-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 22 weeks
Other-event reporting threshold: 0%

CTCAE vr. 5 terms used

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	0 / 33	18 / 33	5 / 33
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	0 / 36	26 / 36	3 / 36

Group identifiers: EG000: Arm I (Acupuncture, Acupressure, Cryotherapy) · EG001: Arm II (Cryotherapy)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
17
num At Risk
33
group Id
EG001
num Affected
22
num At Risk
36
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
15
num At Risk
33
group Id
EG001
num Affected
26
num At Risk
36
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
33
group Id
EG001
num Affected
0
num At Risk
36
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Reported as Dry mouth; Mucositis oral; Oral pain; or Oral dysesthesia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
7
num At Risk
33
group Id
EG001
num Affected
8
num At Risk
36
term
Oral Symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Reported as Abdominal pain and Dyspepsia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
33
group Id
EG001
num Affected
10
num At Risk
36
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 or more Events reported as Back pain, Muscle cramp, Pain in extremity, Non-cardiac chest pain
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
33
group Id
EG001
num Affected
7
num At Risk
36
term
Other Body Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
33
group Id
EG001
num Affected
5
num At Risk
36
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
33
group Id
EG001
num Affected
3
num At Risk
36
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
33
group Id
EG001
num Affected
1
num At Risk
36
term
Dysarthria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
33
group Id
EG001
num Affected
2
num At Risk
36
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
33
group Id
EG001
num Affected
4
num At Risk
36
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
33
group Id
EG001
num Affected
8
num At Risk
36
term
Anorexia

Complete source fields

description

CTCAE vr. 5 terms used

event Groups

deaths Num Affected
5
deaths Num At Risk
33
description
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
id
EG000
other Num Affected
18
other Num At Risk
33
serious Num Affected
0
serious Num At Risk
33
title
Arm I (Acupuncture, Acupressure, Cryotherapy)
deaths Num Affected
3
deaths Num At Risk
36
description
Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
id
EG001
other Num Affected
26
other Num At Risk
36
serious Num Affected
0
serious Num At Risk
36
title
Arm II (Cryotherapy)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
17
num At Risk
33
group Id
EG001
num Affected
22
num At Risk
36
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
15
num At Risk
33
group Id
EG001
num Affected
26
num At Risk
36
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
33
group Id
EG001
num Affected
0
num At Risk
36
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Reported as Dry mouth; Mucositis oral; Oral pain; or Oral dysesthesia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
7
num At Risk
33
group Id
EG001
num Affected
8
num At Risk
36
term
Oral Symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Reported as Abdominal pain and Dyspepsia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
33
group Id
EG001
num Affected
10
num At Risk
36
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 or more Events reported as Back pain, Muscle cramp, Pain in extremity, Non-cardiac chest pain
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
33
group Id
EG001
num Affected
7
num At Risk
36
term
Other Body Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
33
group Id
EG001
num Affected
5
num At Risk
36
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
33
group Id
EG001
num Affected
3
num At Risk
36
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
33
group Id
EG001
num Affected
1
num At Risk
36
term
Dysarthria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
33
group Id
EG001
num Affected
2
num At Risk
36
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
33
group Id
EG001
num Affected
4
num At Risk
36
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
33
group Id
EG001
num Affected
8
num At Risk
36
term
Anorexia

time Frame

22 weeks

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Preserved source evidence · Not medical advice