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CompletedNCT00440089Updated May 25, 2010

Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors

A Phase 2/3 interventional study of Hands-on-Healing in Breast Cancer, sponsored by University of California, San Diego. Completed at 2 sites in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-05-25.

Sponsored by University of California, San Diego · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and immune function in breast cancer survivors. Participants may be randomized to one of three groups: hands-on-healing, touch alone, or a control group.

Read the detailed description

Please see our website at http://healing.ucsd.edu for detailed information on the study.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Cancer
  • Fatigue
  • Breast Cancer
  • Healing
  • Energy Healing
  • Complementary
  • Alternative
  • Immune
  • Cytokine
  • Hormone
  • Cortisol
  • Placebo
  • Mock Healing
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 76 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Premenopausal and postmenopausal women between the ages of 18 to 70 years.
  • Ability to give informed consent.
  • Breast cancer survivors who have undergone surgery, including lumpectomy and simple or total mastectomy, followed by chemotherapy or a combination of chemo- and radio-therapy. We have elected to study survivors instead of patients actively undergoing treatment to alleviate subject burden and risk during this protocol.
  • Stage I to III breast cancer survivors.
  • Breast cancer survivors who have finished their chemotherapy and/or radiotherapy at least one month prior to 60 months prior.
  • Breast cancer survivors with above-normative levels of fatigue.

Exclusion criteria

Exclusion Criteria:

  • Breast cancer patients who are currently receiving or who are scheduled to receive radiation or chemotherapy during the course of this intervention study.
  • Patients with current major depression, current or history of prior bipolar illness, currently on psychotropic medications.
  • Patients with other diseases that are known to induce fatigue (e.g., thyroid disorder; sleep disorders).
  • Patients with other inflammatory diseases that affect cytokine levels.
  • Patients with a history of other cancers, and stage IV breast cancer.
  • Patients undergoing current chemotherapy and/or radiotherapy.
  • Men with breast cancer.
  • Substance abuse/dependence.
  • Continued use of another biofield-based intervention (e.g., Reiki, Qi-Gong, Healing Touch, Therapeutic Touch, Johrei).
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
76 participants (actual)

Interventions

  • BehavioralHands-on-Healing
06

What researchers measure

Primary outcomes

  1. Multiple Fatigue Symptom Inventory

Secondary outcomes

  1. Inflammatory Immune Markers

  2. Diurnal Cortisol Variability

07

Study locations

2 sites
  • Clinical Research Center, UCSD Campus
    La Jolla, California 92037, United States
  • General Clinical Research Center, UCSD Medical Center
    San Diego/Hillcrest, California 92103, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00440089
Lead sponsor
University of California, San Diego
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
First posted
Feb 26, 2007
Start date
Oct 2005
Primary completion
Sep 2009
Completion
Sep 2009
Last update
May 25, 2010

Study contacts

Shamini Jain, Ph.D.
principal investigator · University of California, Los Angeles
Paul J Mills, Ph.D.
principal investigator · UCSD School of Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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