Health TrialsbyHealthPanel

Effects, Metabolic Mechanisms and Predictors of Response to Acupuncture in Treating Psychoneurological Symptoms Among Breast Cancer Survivors

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

The purpose of this study is to examine the effect, mediators and predictors of treatment response of acupuncture in treating the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) among breast cancer survivors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age

With histologically confirmed Stage 0-III ER/PR-positive HER2-negative breast cancer

Currently receiving adjuvant endocrine therapy

Completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior to recruitment

Disqualifiers

Taking methylsulfonylmethane or glutathione supplements

Physically or cognitively unable to complete the study procedures

Pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Behavioral

    All participants will receive a semi-standardized acupuncture protocol with needle penetrating to the skin. Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.

  • Sham acupuncture

    Behavioral

    Participants will receive no-touch control needle on non- acupuncture points, with the tip that does not contact the skin. Participants will receive 2 sham acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each sham acupuncture treatment will take 30 minutes.

Treatment groups

252 Participants
are divided into 3 treatment groups
Group A: Acupuncture groupExperimental treatment 1 intervention
Group B: Sham acupuncture groupSham comparator 1 intervention
Group C: Usual care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The psychoneurological symptom cluster

Psychoneurological symptom cluster: The psychoneurological symptom cluster will be calculated as the mean of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 T-scores for Pain Interference, Fatigue, and Sleep Disturbance. Each domain is scored as a standardized T-score (approximate range 20-80), with higher scores indicating worse symptom severity. Higher composite scores indicate greater psychoneurological symptom burden.

Time frame
week 0, week 6, week 12, week 24

Secondary outcomes

1

PROMIS Pain Interference

Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more

Time frame
week 0, week 6, week 12, week 24
2

PROMIS fatigue

Scores range from 4-20; higher scores indicate that severe fatigue

Time frame
week 0, week 6, week 12, week 24
3

PROMIS sleep disturbance

Scores range from 4-20; higher scores indicate that severe sleep disturbance

Time frame
Scores range from 4-20; higher scores indicate that severe fatigue
4

Serum methylsulfonylmethane concentration

Change in serum methylsulfonylmethane concentration.

Time frame
week 0, week 6, week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: