Breast CancerPhase 2/3NCT00440089
Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors
A Phase 2/3 study testing Hands-on-Healing in people with Breast Cancer, run by University of California, San Diego at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hands-on-Healing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Sep 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Men with breast cancer.
- Substance abuse/dependence.
- Continued use of another biofield-based intervention (e.g., Reiki, Qi-Gong, Healing Touch, Therapeutic Touch, Johrei).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Research Center, UCSD Campus
La Jolla, California, 92037
General Clinical Research Center, UCSD Medical Center
San Diego/Hillcrest, California, 92103
About this study
Official title: Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors
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.
- Conditions
- Breast Cancer
- Being tested
- Hands-on-Healing
- Keywords
- Cancer, Fatigue, Breast Cancer, Healing, Energy Healing, Complementary, Alternative, Immune, Cytokine, Hormone, Cortisol, Placebo, Mock Healing
- Medical subject headings
- Breast Neoplasms, Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-on-HealingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Fatigue Symptom Inventory
Secondary outcomes (2)
Inflammatory Immune Markers
Diurnal Cortisol Variability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startOct 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Shamini Jain, Ph.D., Principal investigator, University of California, Los AngelesPaul J Mills, Ph.D., Principal investigator, UCSD School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440089
- Sponsor's protocol ID
- F31AT003021
- Other IDs
- F31AT003021
- Status last verified
- Nov 2009
- First submitted
- 23 Feb 2007
- Last updated
- 25 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00440089
- Acronym / sponsor ID
- F31AT003021
- Conditions
- Breast Cancer
- Keywords
- Cancer, Fatigue, Breast Cancer, Healing, Energy Healing, Complementary, Alternative, Immune
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Oct 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please see our website at http://healing.ucsd.edu for detailed information on the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hands-on-Healing | Behavioural | – |
Primary outcome
Multiple Fatigue Symptom Inventory
2 secondary outcomes
Inflammatory Immune Markers
Diurnal Cortisol Variability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamini Jain, Ph.D. principal investigator
University of California, Los Angeles
Paul J Mills, Ph.D. principal investigator
UCSD School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hands-on-Healing in people with Breast Cancer, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Fatigue Symptom Inventory. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2010.