Effects of Diet and Osteopathy on Quality of Life and Inflammation in Breast Cancer Patients Under Hormonal Therapy
NCT ID: NCT06164119
Last Updated: 2024-03-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
600 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-19
Study Completion Date
2025-12-31
Brief Summary
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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.
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.
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.
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.
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Detailed Description
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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.
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
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Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
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.
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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A1: manual treatment with osteopathic techniques and nutritional treatment in premenopausal patients
Premenopausal 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).
Group Type
EXPERIMENTAL
manual treatment with osteopathic techniques and nutritional treatment
Intervention Type
OTHER
manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet)
A2: manual treatment with osteopathic techniques in premenopausal patients
Premenopausal 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).
Group Type
EXPERIMENTAL
manual treatment with osteopathic techniques
Intervention Type
OTHER
manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques)
A3: nutritional treatment in premenopausal patients
Premenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with nutritional treatment (personalized Mediterranean Diet).
Group Type
EXPERIMENTAL
nutritional treatment
Intervention Type
OTHER
nutritional treatment (personalized Mediterranean Diet)
A4: control group in premenopausal patients
Premenopausal 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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
B1: osteopathic techniques and nutritional treatment in postmenopausal patients
Postmenopausal 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).
Group Type
EXPERIMENTAL
manual treatment with osteopathic techniques and nutritional treatment
Intervention Type
OTHER
manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet)
B2: manual treatment with osteopathic techniques in postmenopausal patients
Postmenopausal breast cancer patients under aromatase inhibitors are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques).
Group Type
EXPERIMENTAL
manual treatment with osteopathic techniques
Intervention Type
OTHER
manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques)
B3: nutritional treatment in postmenopausal patients
Postmenopausal breast cancer patients under aromatase inhibitors are treated with nutritional treatment (personalized Mediterranean Diet).
Group Type
EXPERIMENTAL
nutritional treatment
Intervention Type
OTHER
nutritional treatment (personalized Mediterranean Diet)
B4: control group in postmenopausal patients
Postmenopausal 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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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manual treatment with osteopathic techniques and nutritional treatment
manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques) and nutritional treatment (personalized Mediterranean Diet)
Intervention Type
OTHER
manual treatment with osteopathic techniques
manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques)
Intervention Type
OTHER
nutritional treatment
nutritional treatment (personalized Mediterranean Diet)
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with or without neoadjuvant or adjuvant chemotherapy
* Patients with a BMI \> 18.5 kg/m\^2
* Absence of language barrier
* 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
* Patients with or without neoadjuvant or adjuvant chemotherapy
* Patients with a BMI \> 18.5 kg/m\^2
* Absence of language barrier
Exclusion Criteria
* 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
* 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.
* 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
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Cristina Ferraris, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Locations
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INT 107/23
Identifier Type: -
Identifier Source: org_study_id
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