Trial Outcomes & Findings for Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer (NCT NCT02589938)

Last Updated: 2025-09-08

Results Overview

Self reported Xerostomia questionnaire consists of eight items (scored on an 11-point scale; 0-10), has been validated in several cohorts, and is regarded as the gold-standard measure for xerostomia.The questions are equally divided into 4 items about oral dryness while eating or chewing and 4 items about dryness while not eating or chewing. Item scores are summed and transformed linearly to produce a final summary score between 0 and 80. Higher scores represent more xerostomia. Questionnaire is completed prior to randomization and at each time point week 4, week 8, week 12, and end of study.

Recruitment status

COMPLETED

Study phase

Target enrollment

258 participants

Primary outcome timeframe

Baseline to 4, 8, 12, 26 weeks post acupuncture

Results posted on

2025-09-08

Participant Flow

Study was designed with first enrollment July 29,2013 under the oversight of MD Anderson (MDA) Community Clinical Oncology Program (CCOP) Research Base (RB) (NCI Division of Cancer Prevention (DCP) #MDA 04-01; MDA Protocol #2010-0547). Twenty-eight participants recruited from multiple centers. After the MDA CCOP RB was closed, the trial transferred to Wake Forest (WF) NCI Community Oncology Research Program (NCORP) RB (2UG1CA189824) where the trial continued (WF-97115) from April 2016-June 2021.

258 of 281 eligible screened participants enrolled and randomized into study. Reasons for the 23 which chose not to participate: 16 no reason given 5 Too busy 1 did not want randomization 1 distance.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	86	86	86
Overall Study COMPLETED	62	73	69
Overall Study NOT COMPLETED	24	13	17

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Withdrawal by Subject	11	5	6
Overall Study Lost to Follow-up	3	3	3
Overall Study Death	1	0	1
Overall Study Protocol Violation	6	2	3
Overall Study Physician Decision	1	0	0
Overall Study Other: includes Patient found to be ineligible, distance, no benefit, lost insurance	2	3	4

Baseline Characteristics

Some outcome values are missing for participants at baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Oral Hygiene n=86 Participants 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.	Standard Oral Hygiene + True Acupuncture n=86 Participants 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.	Standard Oral Hygiene + Sham Acupuncture n=86 Participants 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.	Total n=258 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 9.2 • n=86 Participants	65.0 years STANDARD_DEVIATION 8.6 • n=86 Participants	64.4 years STANDARD_DEVIATION 9.9 • n=86 Participants	65.0 years STANDARD_DEVIATION 9.2 • n=258 Participants
Age, Customized Age Stratification (years) · <= 40 years	0 Participants n=86 Participants	0 Participants n=86 Participants	2 Participants n=86 Participants	2 Participants n=258 Participants
Age, Customized Age Stratification (years) · 41-55 years	16 Participants n=86 Participants	14 Participants n=86 Participants	13 Participants n=86 Participants	43 Participants n=258 Participants
Age, Customized Age Stratification (years) · 56-70 years	46 Participants n=86 Participants	50 Participants n=86 Participants	47 Participants n=86 Participants	143 Participants n=258 Participants
Age, Customized Age Stratification (years) · > 70 years	24 Participants n=86 Participants	22 Participants n=86 Participants	24 Participants n=86 Participants	70 Participants n=258 Participants
Sex: Female, Male Female	20 Participants n=86 Participants	18 Participants n=86 Participants	19 Participants n=86 Participants	57 Participants n=258 Participants
Sex: Female, Male Male	66 Participants n=86 Participants	68 Participants n=86 Participants	67 Participants n=86 Participants	201 Participants n=258 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=86 Participants	3 Participants n=86 Participants	7 Participants n=86 Participants	16 Participants n=258 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=86 Participants	82 Participants n=86 Participants	78 Participants n=86 Participants	238 Participants n=258 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=86 Participants	1 Participants n=86 Participants	1 Participants n=86 Participants	4 Participants n=258 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=86 Participants	1 Participants n=86 Participants	0 Participants n=86 Participants	2 Participants n=258 Participants
Race (NIH/OMB) Asian	7 Participants n=86 Participants	4 Participants n=86 Participants	2 Participants n=86 Participants	13 Participants n=258 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=86 Participants	0 Participants n=86 Participants	0 Participants n=86 Participants	1 Participants n=258 Participants
Race (NIH/OMB) Black or African American	2 Participants n=86 Participants	2 Participants n=86 Participants	5 Participants n=86 Participants	9 Participants n=258 Participants
Race (NIH/OMB) White	75 Participants n=86 Participants	77 Participants n=86 Participants	77 Participants n=86 Participants	229 Participants n=258 Participants
Race (NIH/OMB) More than one race	0 Participants n=86 Participants	2 Participants n=86 Participants	2 Participants n=86 Participants	4 Participants n=258 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=86 Participants	0 Participants n=86 Participants	0 Participants n=86 Participants	0 Participants n=258 Participants
Region of Enrollment United States	86 participants n=86 Participants	86 participants n=86 Participants	86 participants n=86 Participants	258 participants n=258 Participants
Insurance - Medicare	34 Participants n=86 Participants	32 Participants n=86 Participants	35 Participants n=86 Participants	101 Participants n=258 Participants
Insurance - Medicaid	8 Participants n=86 Participants	2 Participants n=86 Participants	5 Participants n=86 Participants	15 Participants n=258 Participants
Insurance - Private	47 Participants n=86 Participants	56 Participants n=86 Participants	51 Participants n=86 Participants	154 Participants n=258 Participants
Insurance - None	4 Participants n=86 Participants	4 Participants n=86 Participants	5 Participants n=86 Participants	13 Participants n=258 Participants
Body Mass Index (BMI)	27.6 kg/m^2 STANDARD_DEVIATION 6.2 • n=86 Participants	26.0 kg/m^2 STANDARD_DEVIATION 4.3 • n=86 Participants	26.5 kg/m^2 STANDARD_DEVIATION 5.7 • n=86 Participants	26.7 kg/m^2 STANDARD_DEVIATION 5.5 • n=258 Participants
Education High School/GED	20 Participants n=86 Participants	18 Participants n=86 Participants	17 Participants n=86 Participants	55 Participants n=258 Participants
Education Some college/training	31 Participants n=86 Participants	27 Participants n=86 Participants	30 Participants n=86 Participants	88 Participants n=258 Participants
Education College degree (BA/BS)	15 Participants n=86 Participants	20 Participants n=86 Participants	16 Participants n=86 Participants	51 Participants n=258 Participants
Education Advanced degree	10 Participants n=86 Participants	11 Participants n=86 Participants	13 Participants n=86 Participants	34 Participants n=258 Participants
Education Unknown	10 Participants n=86 Participants	10 Participants n=86 Participants	10 Participants n=86 Participants	30 Participants n=258 Participants
Job Status Retired	30 Participants n=86 Participants	37 Participants n=86 Participants	28 Participants n=86 Participants	95 Participants n=258 Participants
Job Status Employed (FT/PT)	31 Participants n=86 Participants	29 Participants n=86 Participants	26 Participants n=86 Participants	86 Participants n=258 Participants
Job Status Disabled - unable to work	10 Participants n=86 Participants	5 Participants n=86 Participants	7 Participants n=86 Participants	22 Participants n=258 Participants
Job Status Other/Unknown	15 Participants n=86 Participants	15 Participants n=86 Participants	25 Participants n=86 Participants	55 Participants n=258 Participants
Baseline values for outcomes Xerostomia Questionnaire (XQ) Score (scale 0-80)	63.2 scoring on a scale STANDARD_DEVIATION 16.8 • n=84 Participants • Some outcome values are missing for participants at baseline	63.0 scoring on a scale STANDARD_DEVIATION 17.1 • n=85 Participants • Some outcome values are missing for participants at baseline	62.1 scoring on a scale STANDARD_DEVIATION 17.7 • n=85 Participants • Some outcome values are missing for participants at baseline	62.7 scoring on a scale STANDARD_DEVIATION 17.1 • n=254 Participants • Some outcome values are missing for participants at baseline
Baseline values for outcomes FACT-G Total Score (scale 0-108)	94.8 scoring on a scale STANDARD_DEVIATION 15.9 • n=83 Participants • Some outcome values are missing for participants at baseline	98.8 scoring on a scale STANDARD_DEVIATION 15.5 • n=86 Participants • Some outcome values are missing for participants at baseline	97.7 scoring on a scale STANDARD_DEVIATION 15.1 • n=85 Participants • Some outcome values are missing for participants at baseline	97.1 scoring on a scale STANDARD_DEVIATION 15.5 • n=254 Participants • Some outcome values are missing for participants at baseline
Baseline values for outcomes Acupuncture Expectancy Scale (AES) Score (scale 4-20)	12.7 scoring on a scale STANDARD_DEVIATION 4.3 • n=82 Participants • Some outcome values are missing for participants at baseline	11.9 scoring on a scale STANDARD_DEVIATION 4.1 • n=86 Participants • Some outcome values are missing for participants at baseline	11.7 scoring on a scale STANDARD_DEVIATION 3.7 • n=84 Participants • Some outcome values are missing for participants at baseline	12.1 scoring on a scale STANDARD_DEVIATION 4.0 • n=252 Participants • Some outcome values are missing for participants at baseline

PRIMARY outcome

Timeframe: Baseline to 4, 8, 12, 26 weeks post acupuncture

Population: Intent to treat analysis. Considered and utilized all data available at each timepoint.

Outcome measures

Outcome measures
Measure	Standard Oral Hygiene n=86 Participants 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.	Standard Oral Hygiene + True Acupuncture n=86 Participants 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.	Standard Oral Hygiene + Sham Acupuncture n=86 Participants 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.
Xerostomia Questionnaire Scores Week 4	57.3 score on a scale 0-80 Interval 54.0 to 60.6	50.6 score on a scale 0-80 Interval 47.7 to 53.5	55.0 score on a scale 0-80 Interval 52.0 to 58.0
Xerostomia Questionnaire Scores Week 8	55.2 score on a scale 0-80 Interval 51.3 to 59.1	48.3 score on a scale 0-80 Interval 45.3 to 52.3	51.2 score on a scale 0-80 Interval 47.6 to 54.8
Xerostomia Questionnaire Scores Week 12	54.8 score on a scale 0-80 Interval 50.9 to 58.8	48.9 score on a scale 0-80 Interval 45.3 to 52.6	49.9 score on a scale 0-80 Interval 46.2 to 53.7
Xerostomia Questionnaire Scores Week 26	54.4 score on a scale 0-80 Interval 50.4 to 58.4	49.2 score on a scale 0-80 Interval 45.5 to 52.9	47.4 score on a scale 0-80 Interval 43.6 to 51.2

SECONDARY outcome

Timeframe: Baseline, 4 , 8 , 12, and 26 weeks

Population: Intent to treat analysis. Considered and utilized all data available at each timepoint.

The FACT-G QOL instrument discriminates between individuals with metastatic and non-metastatic disease, as well as between patients at different stages of illness. The scale has good concurrent validity, high internal consistency (0.89), and good test-re-test reliability (0.82 to 0.88). The total score is reported, which is a combination of the subscales of physical, social/family, emotional, and functional well-being, with higher scores representing better QOL. Scale range 0-108

Outcome measures

Outcome measures
Measure	Standard Oral Hygiene n=86 Participants 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.	Standard Oral Hygiene + True Acupuncture n=86 Participants 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.	Standard Oral Hygiene + Sham Acupuncture n=86 Participants 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.
Functional Assessment of Cancer Therapy (FACT-G) Total Week 4	97.7 score on a scale 0-108 Interval 95.8 to 99.6	101.6 score on a scale 0-108 Interval 100.0 to 103.2	100.1 score on a scale 0-108 Interval 98.4 to 101.8
Functional Assessment of Cancer Therapy (FACT-G) Total Week 8	99.5 score on a scale 0-108 Interval 97.4 to 101.6	101.1 score on a scale 0-108 Interval 99.1 to 103.2	100.1 score on a scale 0-108 Interval 98.2 to 102.1
Functional Assessment of Cancer Therapy (FACT-G) Total Week 12	97.4 score on a scale 0-108 Interval 95.5 to 99.4	102.1 score on a scale 0-108 Interval 100.3 to 103.8	98.4 score on a scale 0-108 Interval 96.6 to 100.2
Functional Assessment of Cancer Therapy (FACT-G) Total Week 26	98.7 score on a scale 0-108 Interval 96.2 to 101.1	100.5 score on a scale 0-108 Interval 98.2 to 102.7	100.1 score on a scale 0-108 Interval 97.8 to 102.4

SECONDARY outcome

Timeframe: Week 4

Population: Intent to treat analysis excluding standard oral hygiene group. Considered and utilized all data available at each timepoint. AES was not collected for the standard oral hygiene arm per protocol specifications. Standard oral hygiene participants were not to receive any form of acupuncture making this outcome not applicable for these participants and therefore not collected.

The 4-item AES was used to ensure there were no baseline group differences in expectations related to the benefits of acupuncture on dry mouth and to assess aspects of blinding after the first 4 weeks of acupuncture for the TA and SA groups. The AES is reliable (α=0·82) and valid by positive correlation with patient self-reported efficacy and satisfaction. The scale has been further validated among cancer patients who were acupuncture naïve. Scale from 4-20.

Outcome measures

Outcome measures
Measure	Standard Oral Hygiene n=86 Participants 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.	Standard Oral Hygiene + True Acupuncture n=86 Participants 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.	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.
The Acupuncture Expectancy Scale (AES)	10.8 score on a scale 4-20 Interval 10.0 to 11.5	10.7 score on a scale 4-20 Interval 9.9 to 11.5	—

Adverse Events

Standard Oral Hygiene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard Oral Hygiene + True Acupuncture

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Oral Hygiene + Sham Acupuncture

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Oral Hygiene n=86 participants at risk 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.	Standard Oral Hygiene + True Acupuncture n=86 participants at risk 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.	Standard Oral Hygiene + Sham Acupuncture n=86 participants at risk 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.
General disorders Edema face	0.00% 0/86 • 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. 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.	0.00% 0/86 • 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. 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.	1.2% 1/86 • Number of events 1 • 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. 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.
General disorders Flu like systoms	0.00% 0/86 • 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. 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.	0.00% 0/86 • 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. 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.	1.2% 1/86 • Number of events 1 • 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. 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.
Musculoskeletal and connective tissue disorders Joint Pain	0.00% 0/86 • 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. 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.	0.00% 0/86 • 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. 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.	1.2% 1/86 • Number of events 1 • 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. 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.
Vascular disorders Hypertension	0.00% 0/86 • 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. 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.	1.2% 1/86 • Number of events 1 • 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. 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.	0.00% 0/86 • 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. 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.
Nervous system disorders Headache	0.00% 0/86 • 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. 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.	1.2% 1/86 • Number of events 1 • 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. 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.	0.00% 0/86 • 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. 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.
Injury, poisoning and procedural complications Bruising	0.00% 0/86 • 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. 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.	1.2% 1/86 • Number of events 1 • 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. 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.	0.00% 0/86 • 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. 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.

Additional Information

Lead Biostatistician (Dr. Emily Dressler)

Wake Forest NCORP Research Base

Phone: 336-716-0891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place