Participant flow

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.

groups

1. 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

   FG000

   title

   Standard Oral Hygiene

2. 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

   FG001

   title

   Standard Oral Hygiene + True Acupuncture

3. 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

   FG002

   title

   Standard Oral Hygiene + Sham Acupuncture

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         6

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         3

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      type

      Other: includes Patient found to be ineligible, distance, no benefit, lost insurance

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         86

      2. group Id

         FG001

         num Subjects

         86

      3. group Id

         FG002

         num Subjects

         86

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         62

      2. group Id

         FG001

         num Subjects

         73

      3. group Id

         FG002

         num Subjects

         69

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         17

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

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.

recruitment Details

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.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice