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

NCT06164119 | Unknown DMC

• 1 other identifier: INT 107/23
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Keywords

hormonal therapy; treatment-related adverse events; osteopathic techniques; diet; quality of life

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (27)

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

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

• Body weight

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

• Body composition

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

• Food habits

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

• Hemoglobin

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

Study Arms (8)

A1: manual treatment with osteopathic techniques and nutritional treatment in premenopausal patients

EXPERIMENTAL

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).

Other: manual treatment with osteopathic techniques and nutritional treatment

A2: manual treatment with osteopathic techniques in premenopausal patients

EXPERIMENTAL

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).

Other: manual treatment with osteopathic techniques

A3: nutritional treatment in premenopausal patients

EXPERIMENTAL

Premenopausal breast cancer patients under tamoxifen and/or LHRH analogues are treated with nutritional treatment (personalized Mediterranean Diet).

Other: nutritional treatment

A4: control group in premenopausal patients

NO INTERVENTION

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

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).

Other: manual treatment with osteopathic techniques and nutritional treatment

B2: manual treatment with osteopathic techniques in postmenopausal patients

EXPERIMENTAL

Postmenopausal breast cancer patients under aromatase inhibitors are treated with manual treatment with osteopathic techniques (8 once-a-week manual treatments with osteopathic techniques).

Other: manual treatment with osteopathic techniques

B3: nutritional treatment in postmenopausal patients

EXPERIMENTAL

Postmenopausal breast cancer patients under aromatase inhibitors are treated with nutritional treatment (personalized Mediterranean Diet).

Other: nutritional treatment

B4: control group in postmenopausal patients

NO INTERVENTION

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.

Interventions

manual treatment with osteopathic techniques and nutritional treatment OTHER

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

A1: manual treatment with osteopathic techniques and nutritional treatment in premenopausal patients; B1: osteopathic techniques and nutritional treatment in postmenopausal patients

manual treatment with osteopathic techniques OTHER

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

A2: manual treatment with osteopathic techniques in premenopausal patients; B2: manual treatment with osteopathic techniques in postmenopausal patients

nutritional treatment OTHER

nutritional treatment (personalized Mediterranean Diet)

A3: nutritional treatment in premenopausal patients; B3: nutritional treatment in postmenopausal patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cristina Ferraris, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 19, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2023-12

Locations

IT (1)