Breast CancerNCT00565305
Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment
A study testing Healing Touch and Standard Treatment in people with Breast Cancer, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this research study is to understand effects of a complementary medicine therapy, Healing Touch on quality of life and immunity of patients who are receiving treatment for breast cancer. Healing Touch is a Holistic Therapy used as an adjunct to medical treatment. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Healing Touch and Standard Treatment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Nov 2009
- Phase
- Interventional
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients who have received either a mastectomy or breast conservative surgery
- Diagnosis of Stage I-IIIa breast cancer,
- Receiving either chemotherapy + radiation or radiation alone
Who cannot join
- Past history of cancer
- Recurrent cancer
- Greater than Stage IIIa breast cancer
- History of immunosuppressive disorders (e.g. HIV, AIDS, hepatitis, etc.)
- On immunosuppressive medications
- On corticosteroids (e.g. Prednisone)
Trial locations and contacts
1 site in 1 country.
United States1 site
Holden Comprehensive Cancer Center, University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: Quality of Life and Immunity During Breast Cancer Treatment
The purpose of this research study is to understand effects of a complementary medicine therapy, Healing Touch on quality of life and immunity of patients who are receiving treatment for breast cancer. Healing Touch is a Holistic Therapy used as an adjunct to medical treatment. The goal of Healing Touch is to restore energy and vitality to the body as a patient is receiving treatment for cancer. Treatments include light touch on specific points on the body as well as around the body, to increase well-being and support the body's ability to heal. Healing Touch has been shown to increase relaxation and well-being and to decrease anxiety, pain, and treatment side effects in a variety of illnesses including cancer. Although Healing Touch is frequently used by cancer patients along with their medical treatments, very little is understood about the effects of this treatment on the immune system. The immune system is known to be important in the body's response to fighting cancer. We are studying Healing Touch to help us understand whether or not these treatments are effective in supporting the immune system during breast cancer treatment
Aim 1. To evaluate effects of a healing touch (HT) intervention on cellular immunity among early stage breast cancer patients during radiotherapy.
Read more
Aim 2. To evaluate effects of a Healing Touch (HT) intervention on cytokines associated with radiation damage and acute skin reactions in early stage breast cancer patients during radiotherapy.
Aim 3. To evaluate the effects of a Healing Touch intervention on fatigue and mood in early stage breast cancer patients during radiation treatment.
Read the detailed description
Breast cancer patients use Complementary and Alternative Medicine (CAM) in greater proportions than any other group of cancer patients. The primary reason breast cancer patients cite for use of CAM is strengthening the immune system. Healing touch (HT) is a CAM treatment frequently used by cancer patients to reduce adverse side effects of chemotherapy and radiation and to enhance immunity. HT is classified by NIH as a "biofield" therapy as its effects are proposed to be secondary to manipulation of "energy fields" around the body of a patient. A recent meta-analysis has demonstrated relatively large effects of HT on well-being and on physiological parameters, even from brief treatments. However, to date, there are no data on the effects of HT on immune function among breast cancer patients during treatment. This is particularly important as several immune parameters show long-term suppression or alteration, particularly after combined adjuvant chemotherapy and radiation among breast cancer patients. Additionally, there are no data on the effects of HT on the common side effects of breast cancer treatment which can include profound fatigue and radiation-induced skin damage. Physiological mechanisms underlying possible effects of HT are also poorly understood. This study is designed to reduce this knowledge gap by examining how HT affects cellular immune function and biomarkers related to two of the most problematic side effects of breast cancer treatment, fatigue and radiation-induced tissue damage. Effects on the subjective experience of fatigue and clinician rated skin damage will also be noted. Participants will be 42 early stage breast cancer patients who are receiving a standard course of radiotherapy following breast conservation surgery or mastectomy who have either had chemotherapy or not
The significance of the project is as follows. If positive effects are demonstrated on intermediate outcomes such as immune parameters, markers of radiation damage, and/or fatigue, follow-up studies would be warranted examining effects of HT on a) recurrence and survival, b) incidence of long term side effects of radiation, c) quality of life among breast cancer patients. Additionally, if effects of HT are demonstrated, a critical examination of putative mechanisms of action, using controls for effect of attention, expectation, and other placebo effects will be warranted.
- Conditions
- Breast Cancer
- Being tested
- Healing Touch, Standard Treatment
- Keywords
- Healing Touch, NK cytotoxicity, cytokines, fatigue
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing TouchBehavioural
Healing Touch (HT) is a non-invasive therapeutic approach to healing which describes its mode of action as using touch to modulate the patient's energy system. The goal of HT is to restore harmony and balance in the patient's energy system to assist the person to self-heal.88 Healing Touch, as used here, refers to the techniques taught in Mentgen's standardized curriculum of Healing Touch offered through Healing Touch International and endorsed by the American Holistic Nurse's Association
Standard TreatmentRadiation
4-6 cycles of cytotoxic chemotherapy followed by 5040 cGy of external beam whole breast radiotherapy in 28 fractions usually followed by a boost of 1000-1600 cGy
| Study group | Role | What they receive |
|---|---|---|
| Healing Touch | Experimental | Healing Touch + Standard Treatment Healing Touch treatments daily following standard Radiation Therapy. Standard radiation therapy is part of their medical care and is not administered as part of this study. Protocol of 4 HT techniques will be used including Pain Drain, Chakra connection, Magnetic Unruffling, and Mind Clearing. Treatments will be approximately 20-30 minutes. Receives: Behavioral: Healing Touch; Radiation: Standard Treatment |
| Usual Care | Active comparator | Standard Treatment. These patients receive usual medical care but no additional intervention. Standard treatment is not administered as part of this study but as part of their medical treatment. Receives: Radiation: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NK cell activity; sTNFRII; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions
Measured: six weeks
Secondary outcomes (1)
WBC, distress (POMS), sleep quality, days of interrupted treatment
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startJul 2003
- Primary completionJun 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Susan Lutgendorf, University of Iowa
- Investigators
- Susan K Lutgendorf, PhD, Principal investigator, Department of Psychology, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565305
- Sponsor's protocol ID
- 200305053
- Status last verified
- Mar 2017
- First submitted
- 28 Nov 2007
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Archambeau JO, Pezner R, Wasserman T. Pathophysiology of irradiated skin and breast. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1171-85. doi: 10.1016/0360-3016(94)00423-I.
PubMed 7713781Whiteside TL, Herberman RB. Role of human natural killer cells in health and disease. Clin Diagn Lab Immunol. 1994 Mar;1(2):125-33. doi: 10.1128/cdli.1.2.125-133.1994.
PubMed 7496932Jacobson JS, Verret WJ. Complementary and alternative therapy for breast cancer: the evidence so far. Cancer Pract. 2001 Nov-Dec;9(6):307-10. doi: 10.1046/j.1523-5394.2001.96001.x. No abstract available.
PubMed 11879333Menthe J. Healing touch level I notebook, 1996.
Freel M, Hart L. Nurse's handbook of Alternative & Complementary therapies. Apringhouse, PA: Springhouse Publishing Co.: 61-82, 1999.
Bogulawski M. Therapeutic touch: a facilitator of pain relief. Top Clin Nurs. 1980 Apr;2(1):27-37. No abstract available.
PubMed 6992355Wirth DP, Richardson JT, Eidelman WS. Wound healing and complementary therapies: a review. J Altern Complement Med. 1996 Winter;2(4):493-502. doi: 10.1089/acm.1996.2.493.
PubMed 9395679Astin JA, Harkness E, Ernst E. The efficacy of "distant healing": a systematic review of randomized trials. Ann Intern Med. 2000 Jun 6;132(11):903-10. doi: 10.7326/0003-4819-132-11-200006060-00009.
PubMed 10836918Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000 Feb;18(4):743-53. doi: 10.1200/JCO.2000.18.4.743.
PubMed 10673515Lindley C, Vasa S, Sawyer WT, Winer EP. Quality of life and preferences for treatment following systemic adjuvant therapy for early-stage breast cancer. J Clin Oncol. 1998 Apr;16(4):1380-7. doi: 10.1200/JCO.1998.16.4.1380.
PubMed 9552041Oberst MT, Hughes SH, Chang AS, McCubbin MA. Self-care burden, stress appraisal, and mood among persons receiving radiotherapy. Cancer Nurs. 1991 Apr;14(2):71-8.
PubMed 2044064Melief CJ. Tumor eradication by adoptive transfer of cytotoxic T lymphocytes. Adv Cancer Res. 1992;58:143-75. doi: 10.1016/s0065-230x(08)60294-8. No abstract available.
PubMed 1532109Hamaoka T, Fujiwara H. Phenotypically and functionally distinct T-cell subsets in anti-tumor responses. Immunol Today. 1987;8(9):267-9. doi: 10.1016/0167-5699(87)90186-1.
PubMed 25344282Hung K, Hayashi R, Lafond-Walker A, Lowenstein C, Pardoll D, Levitsky H. The central role of CD4(+) T cells in the antitumor immune response. J Exp Med. 1998 Dec 21;188(12):2357-68. doi: 10.1084/jem.188.12.2357.
PubMed 9858522Levy SM, Herberman RB, Maluish AM, Schlien B, Lippman M. Prognostic risk assessment in primary breast cancer by behavioral and immunological parameters. Health Psychol. 1985;4(2):99-113. doi: 10.1037//0278-6133.4.2.99.
PubMed 4018006
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Immunity During Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT00565305
- Acronym / sponsor ID
- 200305053
- Conditions
- Breast Cancer
- Keywords
- Healing Touch, NK cytotoxicity, cytokines, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Jul 2003 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Nov 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.
The purpose of this research study is to understand effects of a complementary medicine therapy, Healing Touch on quality of life and immunity of patients who are receiving treatment for breast cancer. Healing Touch is a Holistic Therapy used as an adjunct to medical treatment. The goal of Healing Touch is to restore energy and vitality to the body as a patient is receiving treatment for cancer. Treatments include light touch on specific points on the body as well as around the body, to increase well-being and support the body's ability to heal. Healing Touch has been shown to increase relaxation and well-being and to decrease anxiety, pain, and treatment side effects in a variety of illnesses including cancer. Although Healing Touch is frequently used by cancer patients along with their medical treatments, very little is understood about the effects of this treatment on the immune system. The immune system is known to be important in the body's response to fighting cancer. We are studying Healing Touch to help us understand whether or not these treatments are effective in supporting the immune system during breast cancer treatment
Aim 1. To evaluate effects of a healing touch (HT) intervention on cellular immunity among early stage breast cancer patients during radiotherapy.
Aim 2. To evaluate effects of a Healing Touch (HT) intervention on cytokines associated with radiation damage and acute skin reactions in early stage breast cancer patients during radiotherapy.
Aim 3. To evaluate the effects of a Healing Touch intervention on fatigue and mood in early stage breast cancer patients during radiation treatment.
Detailed description
Breast cancer patients use Complementary and Alternative Medicine (CAM) in greater proportions than any other group of cancer patients. The primary reason breast cancer patients cite for use of CAM is strengthening the immune system. Healing touch (HT) is a CAM treatment frequently used by cancer patients to reduce adverse side effects of chemotherapy and radiation and to enhance immunity. HT is classified by NIH as a "biofield" therapy as its effects are proposed to be secondary to manipulation of "energy fields" around the body of a patient. A recent meta-analysis has demonstrated relatively large effects of HT on well-being and on physiological parameters, even from brief treatments. However, to date, there are no data on the effects of HT on immune function among breast cancer patients during treatment. This is particularly important as several immune parameters show long-term suppression or alteration, particularly after combined adjuvant chemotherapy and radiation among breast cancer patients. Additionally, there are no data on the effects of HT on the common side effects of breast cancer treatment which can include profound fatigue and radiation-induced skin damage. Physiological mechanisms underlying possible effects of HT are also poorly understood. This study is designed to reduce this knowledge gap by examining how HT affects cellular immune function and biomarkers related to two of the most problematic side effects of breast cancer treatment, fatigue and radiation-induced tissue damage. Effects on the subjective experience of fatigue and clinician rated skin damage will also be noted. Participants will be 42 early stage breast cancer patients who are receiving a standard course of radiotherapy following breast conservation surgery or mastectomy who have either had chemotherapy or not
The significance of the project is as follows. If positive effects are demonstrated on intermediate outcomes such as immune parameters, markers of radiation damage, and/or fatigue, follow-up studies would be warranted examining effects of HT on a) recurrence and survival, b) incidence of long term side effects of radiation, c) quality of life among breast cancer patients. Additionally, if effects of HT are demonstrated, a critical examination of putative mechanisms of action, using controls for effect of attention, expectation, and other placebo effects will be warranted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healing Touch | Experimental | Behavioral: Healing Touch, Radiation: Standard TreatmentHealing Touch + Standard Treatment Healing Touch treatments daily following standard Radiation Therapy. Standard radiation therapy is part of their medical care and is not administered as part of this study. Protocol of 4 HT techniques will be used including Pain Drain, Chakra connection, Magnetic Unruffling, and Mind Clearing. Treatments will be approximately 20-30 minutes. |
| Usual Care | Active comparator | Radiation: Standard TreatmentStandard Treatment. These patients receive usual medical care but no additional intervention. Standard treatment is not administered as part of this study but as part of their medical treatment. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer patients who have received either a mastectomy or breast conservative surgery
- Diagnosis of Stage I-IIIa breast cancer,
- Receiving either chemotherapy + radiation or radiation alone
Key exclusion criteria (6 listed)
- Past history of cancer
- Recurrent cancer
- Greater than Stage IIIa breast cancer
- History of immunosuppressive disorders (e.g. HIV, AIDS, hepatitis, etc.)
- On immunosuppressive medications
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 |
|---|---|---|
| Healing TouchHealing Touch (HT) is a non-invasive therapeutic approach to healing which describes its mode of action as using touch to modulate the patient's energy system. The goal of HT is to restore harmony and balance in the patient's energy system to assist the person to self-heal.88 Healing Touch, as used here, refers to the techniques taught in Mentgen's standardized curriculum of Healing Touch offered through Healing Touch International and endorsed by the American Holistic Nurse's Association | Behavioural | Healing Touch |
| Standard Treatment4-6 cycles of cytotoxic chemotherapy followed by 5040 cGy of external beam whole breast radiotherapy in 28 fractions usually followed by a boost of 1000-1600 cGy | Radiation | Healing Touch, Usual Care |
Primary outcome
NK cell activity; sTNFRII; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions
Time frame: six weeks
1 secondary outcome
WBC, distress (POMS), sleep quality, days of interrupted treatment
Time frame: six weeks
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 15 Mar 2017.
- Background: PubMed 7713781Archambeau JO, Pezner R, Wasserman T. Pathophysiology of irradiated skin and breast. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1171-85. doi: 10.1016/0360-3016(94)00423-I.
- Background: PubMed 7496932Whiteside TL, Herberman RB. Role of human natural killer cells in health and disease. Clin Diagn Lab Immunol. 1994 Mar;1(2):125-33. doi: 10.1128/cdli.1.2.125-133.1994.
- Background: PubMed 11879333Jacobson JS, Verret WJ. Complementary and alternative therapy for breast cancer: the evidence so far. Cancer Pract. 2001 Nov-Dec;9(6):307-10. doi: 10.1046/j.1523-5394.2001.96001.x. No abstract available.
- BackgroundMenthe J. Healing touch level I notebook, 1996.
- BackgroundFreel M, Hart L. Nurse's handbook of Alternative & Complementary therapies. Apringhouse, PA: Springhouse Publishing Co.: 61-82, 1999.
- Background: PubMed 6992355Bogulawski M. Therapeutic touch: a facilitator of pain relief. Top Clin Nurs. 1980 Apr;2(1):27-37. No abstract available.
- Background: PubMed 9395679Wirth DP, Richardson JT, Eidelman WS. Wound healing and complementary therapies: a review. J Altern Complement Med. 1996 Winter;2(4):493-502. doi: 10.1089/acm.1996.2.493.
- Background: PubMed 10836918Astin JA, Harkness E, Ernst E. The efficacy of "distant healing": a systematic review of randomized trials. Ann Intern Med. 2000 Jun 6;132(11):903-10. doi: 10.7326/0003-4819-132-11-200006060-00009.
- Results publication: PubMed 10673515Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000 Feb;18(4):743-53. doi: 10.1200/JCO.2000.18.4.743.
- Results publication: PubMed 9552041Lindley C, Vasa S, Sawyer WT, Winer EP. Quality of life and preferences for treatment following systemic adjuvant therapy for early-stage breast cancer. J Clin Oncol. 1998 Apr;16(4):1380-7. doi: 10.1200/JCO.1998.16.4.1380.
- Results publication: PubMed 2044064Oberst MT, Hughes SH, Chang AS, McCubbin MA. Self-care burden, stress appraisal, and mood among persons receiving radiotherapy. Cancer Nurs. 1991 Apr;14(2):71-8.
- Results publication: PubMed 1532109Melief CJ. Tumor eradication by adoptive transfer of cytotoxic T lymphocytes. Adv Cancer Res. 1992;58:143-75. doi: 10.1016/s0065-230x(08)60294-8. No abstract available.
- Individual participant dataSharing planned: No
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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.
Susan K Lutgendorf, PhD principal investigator
Department of Psychology, University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Touch and Standard Treatment in people with Breast Cancer, run by University of Iowa at 1 site 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 3 inclusion and 6 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 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
NK cell activity; sTNFRII; IL-1ra; fatigue (FSI); depression (CES-D); acute skin reactions (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565305, which also lists 25 linked publications.
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 15 Mar 2017.