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

F

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status

Enrolling

Conditions

Breast Cancer

Treatments

Other: manual treatment with osteopathic techniques and nutritional treatment
Other: manual treatment with osteopathic techniques
Other: nutritional treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06164119
INT 107/23

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

Female

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

600 participants in 8 patient groups

A1: manual treatment with osteopathic techniques and nutritional treatment in premenopausal patients
Experimental group
Description:
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).
Treatment:
Other: manual treatment with osteopathic techniques and nutritional treatment
A2: manual treatment with osteopathic techniques in premenopausal patients
Experimental group
Description:
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).
Treatment:
Other: manual treatment with osteopathic techniques
A3: nutritional treatment in premenopausal patients
Experimental group
Description:
Premenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with nutritional treatment (personalized Mediterranean Diet).
Treatment:
Other: nutritional treatment
A4: control group in premenopausal patients
No Intervention group
Description:
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.
B1: osteopathic techniques and nutritional treatment in postmenopausal patients
Experimental group
Description:
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).
Treatment:
Other: manual treatment with osteopathic techniques and nutritional treatment
B2: manual treatment with osteopathic techniques in postmenopausal patients
Experimental group
Description:
Postmenopausal breast cancer patients under aromatase inhibitors are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques).
Treatment:
Other: manual treatment with osteopathic techniques
B3: nutritional treatment in postmenopausal patients
Experimental group
Description:
Postmenopausal breast cancer patients under aromatase inhibitors are treated with nutritional treatment (personalized Mediterranean Diet).
Treatment:
Other: nutritional treatment
B4: control group in postmenopausal patients
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Chiara Listorti, MD; Cristina Ferraris, MD

Data sourced from clinicaltrials.gov

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