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AzTrials

Breast CancerSECCONCT06164119

Effects of Diet and Osteopathy on Quality of Life and Inflammation in Breast Cancer Patients Under Hormonal Therapy

A study testing manual treatment with osteopathic techniques and nutritional treatment, manual treatment with osteopathic techniques and nutritional treatment in people with Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Breast cancer patients under hormonal therapy may experience significant adverse events related to this treatment and as a result, failure to adhere to adjuvant therapies or discontinuation of treatment has been reported to be high. Read more about this study

Who is it for?
Ages 18 to 85 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
manual treatment with osteopathic techniques and nutritional treatment, manual treatment with osteopathic techniques and nutritional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteItaly
Study dates
19 Dec 2023to Dec 2025
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 85 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age >18 years
  • Voluntary written informed consent
  • Histologically confirmed estrogen receptor-positive invasive breast cancer or in situ breast cancer after breast surgery
  • Absence of locoregional relapse or distant metastasis
  • Premenopausal or postmenopausal status
  • Hormonal therapy with tamoxifen and/or LHRH analogues or aromatase inhibitors
Show all 9Show fewer
  • Patients with or without neoadjuvant or adjuvant chemotherapy
  • Patients with a BMI > 18.5 kg/m^2
  • Absence of language barrier

Who cannot join

  • Previous hormonal therapy
  • Use of medical treatments that contrast adjuvant hormonal therapy adverse effects (e.g. menopausal symptoms and arthralgia).
  • Underweight patients (BMI <18.5 kg/m^2)
  • Patients diagnosed with eating disorders (e.g. anorexia nervosa, bulimia, binge eating, orthorexia)
  • Psychiatric disorders or cognitive impairments
  • Previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer
Show all 10Show fewer
  • Non-epithelial breast cancer at histological examination
  • In situ lobular breast cancer
  • Participation in other randomized clinical trials that could interfere with current study
  • Patients living distant from trial center and unable to attend for check-ups and meetings.

Trial locations and contacts

1 site in 1 country.

Cristina Ferraris, MD contact

+39 02 2390 2659

cristina.ferraris@istitutotumori.mi.it

Chiara Listorti, MD contact

+39 02 2390 2659

chiara.listorti@istitutotumori.mi.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Chiara Listorti, MD, +39 02 2390 2659, chiara.listorti@istitutotumori.mi.it

    Recruiting

Other trials in Italy

About this study

Official title: A Randomised Effectiveness-implementation Trial for Evaluating Dietary and Manual Treatment With Osteopathic Techniques on Quality of Life and on Modulation of the Inflammatory State of Patients Diagnosed With Breast Cancer Undergoing Antiestrogenic Hormonal Treatment.

Breast cancer patients under hormonal therapy may experience significant adverse events related to this treatment and as a result, failure to adhere to adjuvant therapies or discontinuation of treatment has been reported to be high.

Promoting weight control and the adoption of healthy lifestyle habits in breast cancer survivors has an impact on hormonal status, quality of life and physical functioning, contributing to reduce cancer recurrence risk, cancer-related and chronic-condition-related mortality.

Read more

Manipulation procedures, such as manual treatment with osteopathic techniques, have positive effects on osteoarticular pain, peripheral neuropathies, anxious-depressive disorders, asthenia and sleep disorders, also improving immune and neuroendocrine responses.

The aim of this study is to evaluate the effects of dietary intervention and manual treatment with osteopathic techniques in women diagnosed with breast cancer under antiestrogenic hormonal treatment through the assessment of:

  • modifications of quality of life (QoL)
  • frequency and severity of symptoms related to antiestrogenic hormonal treatment
  • body weight
  • body composition
  • food habits
  • metabolic and inflammatory state
  • physical performance
  • patient's satisfaction to multidisciplinary treatment.

This study focuses on patient's centricity evaluating the effects that long lasting adjuvant therapies have on breast cancer survivors. Improving personalized patient's treatment through collaborative interactions between clinicians, osteopaths and nutrition specialists might result in implementation strategies to determine novel evidence-based treatments for ameliorating patient's adherence to oncological therapies, impacting prognosis and survival.

Read the detailed description

Breast cancer patients under hormonal therapy may experience significant adverse events related to this treatment. Premenopausal women may encounter the classic symptoms of menopausal syndrome: hair thinning or loss; hot flashes, sweating, fatigue, insomnia, joint pain, vaginal dryness, decreased libido, anxious-depressive disorders, cognitive dysfunction; dry eyes; weight gain. Postmenopausal women may instead experience joint stiffness and joint pain, depressive and anxious symptoms, fatigue and irritability.

Since most of these adverse events do not resolve spontaneously a few weeks/months after starting treatment, they often negatively impact patient's quality of life.

As a result of treatment-related adverse events, failure to adhere to adjuvant therapies or discontinuation of treatment has been reported to be high and this may negatively impact patient's prognosis and survival.

Patients with breast cancer frequently experience weight gain during and after adjuvant hormonal treatment. Indeed, menopause, musculoskeletal pain and the consequent physical activity reduction, work together to reduce the basal energy metabolism. On the other side, the psychological distress and the eventual use of food for emotional reward, do promote weight gain. Notably, breast cancer patients who are overweight or obese show an increased risk of overall mortality, cancer-specific mortality, breast cancer relapse or second primary contralateral breast cancer. The explanation lies in the fact that the increase in fat mass is directly correlated to an increased production of estrogens, insulin, leptin and proinflammatory cytokines which, all together, exhibit a mitogenic activity on mammary cells. Proinflammatory cytokines and insulin deregulation on their turn, favor with time the onset of other chronic diseases such as diabetes, dyslipidemia, metabolic syndrome in general, thus increasing the risk of overall mortality. Conversely, weight loss can improve hormonal status, quality of life and physical functioning and contribute to reduce cancer recurrence risk, cancer-related and chronic-condition-related mortality. Therefore, it is important to promote weight control and the adoption of healthy lifestyle habits in breast cancer survivors.

Manipulation procedures, such as manual treatment with osteopathic techniques, involve the mechanical displacement of fluids and the removal of toxic substances with neurovascular and neuromuscular effects, thus producing positive alterations at the metabolic, biochemical and circulatory level. Several studies conducted on patients with breast cancer have supported the positive effect of manual therapy (acupuncture, shiatsu treatments, massages) on the control of various problems such as osteoarticular pain, peripheral neuropathies, anxious-depressive disorders, asthenia and sleep disorders, also improving immune and neuroendocrine responses.

Nevertheless, there are no studies on the effect of manual treatment with osteopathic techniques on the control of symptoms related to the side effects induced by anti-tumor therapies.

The aim of this study is to evaluate the effects of dietary intervention and manual treatment with osteopathic techniques in women diagnosed with breast cancer under antiestrogenic hormonal treatment through the assessment of:

  • modifications of quality of life (QoL)
  • frequency and severity of symptoms related to antiestrogenic hormonal treatment
  • body weight
  • body composition
  • food habits
  • metabolic and inflammatory state
  • physical performance
  • patient's satisfaction to multidisciplinary treatment.

This study focuses on patient's centricity evaluating the effects that long lasting adjuvant therapies have on breast cancer survivors. Improving personalized patient's treatment through collaborative interactions between clinicians, osteopaths and nutrition specialists might result in implementation strategies to determine novel evidence-based treatments for ameliorating patient's adherence to oncological therapies, impacting prognosis and survival.

Conditions
Breast Cancer
Being tested
manual treatment with osteopathic techniques and nutritional treatment, manual treatment with osteopathic techniques, nutritional treatment
Keywords
hormonal therapy, treatment-related adverse events, osteopathic techniques, diet, quality of life
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • manual treatment with osteopathic techniques and nutritional treatmentOther

    manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet)

  • manual treatment with osteopathic techniquesOther

    manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques)

  • nutritional treatmentOther

    nutritional treatment (personalized Mediterranean Diet)

Study groups in NCT06164119
Study groupRoleWhat they receive
A1: manual treatment with osteopathic techniques and nutritional treatment in premenopausal patientsExperimentalPremenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet).
Receives: Other: manual treatment with osteopathic techniques and nutritional treatment
A2: manual treatment with osteopathic techniques in premenopausal patientsExperimentalPremenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques).
Receives: Other: manual treatment with osteopathic techniques
A3: nutritional treatment in premenopausal patientsExperimentalPremenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with nutritional treatment (personalized Mediterranean Diet).
Receives: Other: nutritional treatment
A4: control group in premenopausal patientsNo interventionPremenopausal breast cancer patients under tamoxifen and/or LHRH analogues receive general counselling on healthy dietary habits and lifestyle in accordance to the World Cancer Research Fund (WCRF) guidelines.
B1: osteopathic techniques and nutritional treatment in postmenopausal patientsExperimentalPostmenopausal breast cancer patients under aromatase inhibitors are treated with manual treatment (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet).
Receives: Other: manual treatment with osteopathic techniques and nutritional treatment
B2: manual treatment with osteopathic techniques in postmenopausal patientsExperimentalPostmenopausal breast cancer patients under aromatase inhibitors are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques).
Receives: Other: manual treatment with osteopathic techniques
B3: nutritional treatment in postmenopausal patientsExperimentalPostmenopausal breast cancer patients under aromatase inhibitors are treated with nutritional treatment (personalized Mediterranean Diet).
Receives: Other: nutritional treatment
B4: control group in postmenopausal patientsNo interventionPostmenopausal breast cancer patients under aromatase inhibitors receive general counselling on healthy dietary habits and lifestyle in accordance to the World Cancer Research Fund (WCRF) guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the effect of dietary intervention and manual treatment with osteopathic techniques on quality of life (QoL) of women diagnosed with breast cancer under hormonal treatment

    Quality of life will be assessed using the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire comparing the before-and-after treatment difference in FACT-ES QoL scale (range 0-200; the higher the FACT-ES score, the better the quality of life, QoL) evaluated at baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3).

    The difference between pre treatment (baseline, T0) score and 24-weeks (six months, T2) score of the FACT ES QoL scale will be analyzed by ANOVA, and the interaction between the dietetic treatment and manual treatment with osteopathic techniques will be tested at 5% significance level. In a secondary ANOVA analysis, the baseline-to-52-weeks (T3) follow-up difference of the FACT ES QoL scale scores will additionally be analyzed.

    These analyses will be conducted separately in Groups A and B.

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

Secondary outcomes (27)

  1. Treatment-related adverse events of hormonal treatment in premenopausal and postmenopausal patients

    Symptoms related to hormonal treatment will be evaluated using Menopause Rating Scale (MRS) (range 0-44; higher scores indicating worse symptoms) in Group A and EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC-QLQ-C30/BR23) (range 0-100; higher scores corresponding to worse symptoms) in Group B, respectively.

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  2. Body weight

    Body weight will be evaluated using body mass index (BMI), measuring weight in kilograms divided by the square of height in meters.

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  3. Body composition

    Body composition will be evaluated combining two anthropometric measures: the waist circumference (cm) and calf circumference (cm).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  4. Food habits

    Food habits will be assessed through a food frequency questionnaire.

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  5. Hemoglobin

    Hemoglobin will be assessed collecting blood exams measuring hemoglobin levels (g/dL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  6. Red blood cells

    Red blood cells will be assessed collecting blood exams measuring red blood cells count (cells/mcL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  7. Platelets

    Platelets will be assessed collecting blood exams measuring platelets count (cells/mcL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  8. White blood cells

    White blood cells will be assessed collecting blood exams measuring white blood cells count (cells/mcL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  9. Lymphocytes

    Lymphocytes will be assessed collecting blood exams measuring lymphocytes count (cells/mcL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  10. Monocytes

    Monocytes will be assessed collecting blood exams measuring monocytes count (cells/mcL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  11. Neutrophils

    Neutrophils will be assessed collecting blood exams measuring neutrophils count (cells/mcL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  12. Inflammatory state: erythrocyte sedimentation rate

    inflammatory state will be assessed collecting blood exams measuring erythrocyte sedimentation rate (ESR) (mm/h)

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  13. Vitamin D

    Vitamin D will be assessed collecting blood exams measuring Vitamin D levels (ng,mL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  14. Metabolic state: plasma glycemia

    Metabolic state will be assessed collecting blood exams measuring plasma glycemia (mg/dl)

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  15. Metabolic state: serum insulin concentration

    Metabolic state will be assessed collecting blood exams measuring serum insulin concentration (µU/ml).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  16. Metabolic state: total cholesterol

    Metabolic state will be assessed collecting blood exams measuring total cholesterol (mg/dL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  17. Metabolic state: low-density lipoprotein (LDL) cholesterol

    Metabolic state will be assessed collecting blood exams measuring low-density lipoprotein (LDL) cholesterol (mg/dL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  18. Metabolic state: high-density lipoprotein (HDL) cholesterol

    Metabolic state will be assessed collecting blood exams measuring high-density lipoprotein (HDL) cholesterol (mg/dL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  19. Metabolic state: triglycerides

    Metabolic state will be assessed collecting blood exams measuring triglycerides (mg/dL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  20. Inflammatory state: c-reactive protein (CRP)

    inflammatory state will be assessed collecting blood exams measuring c-reactive protein (CRP) (mg/L).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  21. Sex hormone binding globulin (SHBG)

    Sex hormone binding globulin (SHBG) will be assessed collecting blood exams measuring sex hormone binding globulin levels (SHBG) (nmol/L).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  22. Inflammatory state: Interleukin-6 (IL-6)

    inflammatory state will be assessed collecting blood exams measuring Interleukin-6 (IL-6) levels (pg/mL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  23. Inflammatory state: Tumour necrosis factor-α (TNF-α)

    inflammatory state will be assessed collecting blood exams measuring Tumour necrosis factor-α (TNF-α) levels (pg/ml).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  24. Testosterone

    Testosterone levels will be assessed collecting blood exams measuring testosterone levels (ng/dL).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  25. Modifications of blood lipid profile

    modifications of blood lipid profile will be assessed collecting blood exams measuring plasma lipids by UPLC-MS.

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  26. Physical performance

    Physical performance will be assessed using International Physical Activity Questionnaires (IPAQ) measuring physical activity levels (higher scores indicating higher physical activity).

    Measured: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

  27. Patient's satisfaction to multidisciplinary treatment

    Patient's satisfaction to multidisciplinary treatment will be assessed with Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General questionnaire (FACIT-TS-G) (range 0-25; the higher the score, the better the satisfaction).

    Measured: 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start19 Dec 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
This is an hybrid type I effectiveness-implementation trial, testing the effectiveness of clinical therapeutic interventions, coupled by exploration of the effects of the implementation of the effective intervention(s) in clinical practice (professional practice changes, changes in processes of care, quality of intervention delivery, patient's satisfaction). The effectiveness study will be a before-and-after randomized trial performed according to a 2 × 2 factorial design. Two groups are identified: * Group A: Premenopausal breast cancer patients treated with tamoxifen and/or luteinizing hormone-releasing hormone (LHRH) analogues. * Group B: Postmenopausal breast cancer patients treated with aromatase inhibitors. Patients in each group will be randomly assigned to four treatments arms: Arm 1, manual treatment with osteopathic techniques and nutritional treatment. Arm 2, manual treatment with osteopathic techniques. Arm 3, nutritional treatment. Arm 4, control.
Masking
Single blind
Who is masked
Participant
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06164119
Sponsor's protocol ID
INT 107/23
Acronym
SECCO
Status last verified
Dec 2023
First submitted
1 Dec 2023
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sauter ER. Breast Cancer Prevention: Current Approaches and Future Directions. Eur J Breast Health. 2018 Apr 1;14(2):64-71. doi: 10.5152/ejbh.2018.3978. eCollection 2018 Apr.

    PubMed 29774312

  • Sharma R, Hamilton A, Beith J. LHRH agonists for adjuvant therapy of early breast cancer in premenopausal women. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004562. doi: 10.1002/14651858.CD004562.pub3.

    PubMed 18843661

  • Martino G, Catalano A, Agostino RM, Bellone F, Morabito N, Lasco CG, Vicario CM, Schwarz P, Feldt-Rasmussen U. Quality of life and psychological functioning in postmenopausal women undergoing aromatase inhibitor treatment for early breast cancer. PLoS One. 2020 Mar 26;15(3):e0230681. doi: 10.1371/journal.pone.0230681. eCollection 2020.

    PubMed 32214378

  • Glaus A, Boehme Ch, Thurlimann B, Ruhstaller T, Hsu Schmitz SF, Morant R, Senn HJ, von Moos R. Fatigue and menopausal symptoms in women with breast cancer undergoing hormonal cancer treatment. Ann Oncol. 2006 May;17(5):801-6. doi: 10.1093/annonc/mdl030. Epub 2006 Feb 28.

    PubMed 16507565

  • Mantas, D., Kostakis, J.D. & Markopoulos, C. Aromatase inhibitors: A comprehensive review in mechanisms of action, side effects and treatment in postmenopausal early breast cancer patients. Hellenic J Surg 88, 245-251 (2016). https://doi.org/10.1007/s13126-016-0326-6

  • Henry NL, Azzouz F, Desta Z, Li L, Nguyen AT, Lemler S, Hayden J, Tarpinian K, Yakim E, Flockhart DA, Stearns V, Hayes DF, Storniolo AM. Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer. J Clin Oncol. 2012 Mar 20;30(9):936-42. doi: 10.1200/JCO.2011.38.0261. Epub 2012 Feb 13.

    PubMed 22331951

  • Sestak I, Cuzick J, Sapunar F, Eastell R, Forbes JF, Bianco AR, Buzdar AU; ATAC Trialists' Group. Risk factors for joint symptoms in patients enrolled in the ATAC trial: a retrospective, exploratory analysis. Lancet Oncol. 2008 Sep;9(9):866-72. doi: 10.1016/S1470-2045(08)70182-7. Epub 2008 Aug 12.

    PubMed 18703382

  • Vance V, Mourtzakis M, Hanning R. Relationships Between Weight Change and Physical and Psychological Distress in Early-Stage Breast Cancer Survivors. Cancer Nurs. 2019 May/Jun;42(3):E43-E50. doi: 10.1097/NCC.0000000000000612.

    PubMed 29847347

  • Kangas M, Henry JL, Bryant RA. Posttraumatic stress disorder following cancer. A conceptual and empirical review. Clin Psychol Rev. 2002 May;22(4):499-524. doi: 10.1016/s0272-7358(01)00118-0.

    PubMed 12094509

  • Kadakia KC, Snyder CF, Kidwell KM, Seewald NJ, Flockhart DA, Skaar TC, Desta Z, Rae JM, Otte JL, Carpenter JS, Storniolo AM, Hayes DF, Stearns V, Henry NL. Patient-Reported Outcomes and Early Discontinuation in Aromatase Inhibitor-Treated Postmenopausal Women With Early Stage Breast Cancer. Oncologist. 2016 May;21(5):539-46. doi: 10.1634/theoncologist.2015-0349. Epub 2016 Mar 23.

    PubMed 27009936

  • Murphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012 Jul;134(2):459-78. doi: 10.1007/s10549-012-2114-5. Epub 2012 Jun 12.

    PubMed 22689091

  • Hershman DL, Shao T, Kushi LH, Buono D, Tsai WY, Fehrenbacher L, Kwan M, Gomez SL, Neugut AI. Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011 Apr;126(2):529-37. doi: 10.1007/s10549-010-1132-4. Epub 2010 Aug 28.

    PubMed 20803066

  • Greenlee H, DuPont-Reyes MJ, Balneaves LG, Carlson LE, Cohen MR, Deng G, Johnson JA, Mumber M, Seely D, Zick SM, Boyce LM, Tripathy D. Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment. CA Cancer J Clin. 2017 May 6;67(3):194-232. doi: 10.3322/caac.21397. Epub 2017 Apr 24.

    PubMed 28436999

  • Hernandez-Reif M, Ironson G, Field T, Hurley J, Katz G, Diego M, Weiss S, Fletcher MA, Schanberg S, Kuhn C, Burman I. Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. J Psychosom Res. 2004 Jul;57(1):45-52. doi: 10.1016/S0022-3999(03)00500-2.

    PubMed 15256294

  • Lissoni P, Messina G, Lissoni A, Franco R. The psychoneuroendocrine-immunotherapy of cancer: Historical evolution and clinical results. J Res Med Sci. 2017 Apr 26;22:45. doi: 10.4103/jrms.JRMS_255_16. eCollection 2017.

    PubMed 28567065

Questions about this trial

What is this clinical trial studying?

A study testing manual treatment with osteopathic techniques and nutritional treatment, manual treatment with osteopathic techniques and nutritional treatment in people with Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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 Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cristina Ferraris, MD (+39 02 2390 2659, cristina.ferraris@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the effect of dietary intervention and manual treatment with osteopathic techniques on quality of life (QoL) of women diagnosed with breast cancer under hormonal treatment (time frame: baseline (T0), after 12 weeks (T1), after 24 weeks (T2) and after 52 weeks (T3)). 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 NCT06164119, which also lists 42 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 8 Mar 2024.

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