NCT02589938 · ADVERSE EVENTS

Adverse events

Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer · Source last updated 2026-02-27

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: Collected at weeks 4, 8, 12 and 24. July 29,2013 under the oversight of the MD Anderson Community Clinical Oncology Program Research Base (MDA CCOP RB) (NCI DCP #MDA 04-01; MD Anderson Protocol #2010-0547). (WF-97115) from April 2016 through June 2021.
Other-event reporting threshold: 0%

By protocol definitions, only grade 1-3 adverse events that were deemed definitely, possibly, or probably related to treatment and all grade 3-5 severe adverse events (SAEs) were to be reported.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Standard Oral Hygiene All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care.	0 / 86	0 / 86	1 / 86
Standard Oral Hygiene + True Acupuncture All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. Standard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.	0 / 86	3 / 86	0 / 86
Standard Oral Hygiene + Sham Acupuncture All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. Standard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.	0 / 86	3 / 86	1 / 86

Group identifiers: EG000: Standard Oral Hygiene · EG001: Standard Oral Hygiene + True Acupuncture · EG002: Standard Oral Hygiene + Sham Acupuncture

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
86
num Events
1
term
Edema face
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
86
num Events
1
term
Flu like systoms
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v.50
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
86
num Events
1
term
Joint Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
86
num Events
0
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
86
num Events
0
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
86
num Events
0
term
Bruising

Complete source fields

description

By protocol definitions, only grade 1-3 adverse events that were deemed definitely, possibly, or probably related to treatment and all grade 3-5 severe adverse events (SAEs) were to be reported.

event Groups

deaths Num Affected
1
deaths Num At Risk
86
description
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care.
id
EG000
other Num Affected
0
other Num At Risk
86
serious Num Affected
0
serious Num At Risk
86
title
Standard Oral Hygiene
deaths Num Affected
0
deaths Num At Risk
86
description
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. Standard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
id
EG001
other Num Affected
3
other Num At Risk
86
serious Num Affected
0
serious Num At Risk
86
title
Standard Oral Hygiene + True Acupuncture
deaths Num Affected
1
deaths Num At Risk
86
description
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. Standard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
id
EG002
other Num Affected
3
other Num At Risk
86
serious Num Affected
0
serious Num At Risk
86
title
Standard Oral Hygiene + Sham Acupuncture

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
86
num Events
1
term
Edema face
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
86
num Events
1
term
Flu like systoms
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v.50
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
0
num At Risk
86
num Events
0
group Id
EG002
num Affected
1
num At Risk
86
num Events
1
term
Joint Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
86
num Events
0
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
86
num Events
0
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
1
num At Risk
86
num Events
1
group Id
EG002
num Affected
0
num At Risk
86
num Events
0
term
Bruising

time Frame

Collected at weeks 4, 8, 12 and 24. July 29,2013 under the oversight of the MD Anderson Community Clinical Oncology Program Research Base (MDA CCOP RB) (NCI DCP #MDA 04-01; MD Anderson Protocol #2010-0547). (WF-97115) from April 2016 through June 2021.

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Preserved source evidence · Not medical advice