Activity Program During Aromatase Inhibitor Therapy

Swiss Cancer Institute375 enrolled

Overview

The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant aromatase inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.

After tumor removal, patients with hormone receptor positive breast cancer tumors often receive adjuvant endocrine treatment, with the use of an aromatase inhibitor (AI) being standard of care in the population of postmenopausal women. Common side effects of AI therapy are joint pain, muscle pain, stiffness, fatigue, hot flashes, and weight gain. Arthralgia and/or myalgia can result in lower physical activity and can negatively influence quality of life (QoL). In addition, muscle or joint pain/stiffness are among the main reasons for non-compliance and discontinuation of AI therapy. Because AI therapy is usually administered for 5 and sometimes even 10 years, this is a major clinical challenge. For breast cancer patients undergoing AI therapy, physical activity can provide potential benefit by reducing muscle/joint pain and fatigue and can thus improve QoL. The preventive effect of physical activity on AI side effects, however, remains elusive. In addition, activity programs to reduce AI side effects have so far mostly been rather complex. The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant AI therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients. Furthermore, this trial will assess the effect of physical activity on symptom burden in general and quality of life in patients receiving adjuvant AI therapy. During the follow-up phase, the trial will assess whether this intervention leads to a sustained change in lifestyle regarding activity, less pain, and better treatment adherence in the intervention group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

375

Conditions

Early Breast Cancer

Interventions

Activity programBEHAVIORAL

Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks

ControlBEHAVIORAL

Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures. * Histologically confirmed hormone-receptor-positive newly diagnosed breast cancer, AJCC (American Joint Committee on Cancer) stage I-III * Patient had tumor removal by breast conserving surgery or mastectomy, followed by chemotherapy (if indicated) and/or radiotherapy (if indicated) * Patient is starting adjuvant first-line endocrine treatment with an AI alone (in postmenopausal women) or combined endocrine treatment with an AI and ovarian suppression with an LHRH-agonist (in premenopausal women) * Patient completed the PRO Form Eligibility before registration * Patient is fluent in German, Italian, or French * Patient is willing to wear a wrist worn activity tracker for 24 weeks * Female patient, age ≥ 18 years * WHO performance status 0-2 Exclusion Criteria: * Pre-existing severe medical conditions such as heart or lung problems or musculoskeletal conditions precluding participation in the physical activity program of moderate walking a total of 150 minutes per week as determined by the local investigator * Mild, moderate, or severe pain (other than post-operative pain) in the last 24 hours due to muscle/joint pain on the BPI-SF single item "worst pain" ("worst pain" ≥3) within 7 days prior to registration * Inoperable, locally advanced and/or metastatic breast cancer * Active rheumatoid arthritis * Neoadjuvant endocrine treatment with an AI * NSAIDs, acetaminophen or opioids on a regular basis (\> 1 time per week) * Concurrent participation in other clinical trials or observational studies * Any other serious psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the intervention and follow-up or affect patient compliance with trial procedures.

Locations (32)

Outcomes

Primary Outcomes

Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score

Muscle or joint pain/stiffness will be assessed at baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization by the BPI-SF questionnaire. The BPI-SF is a 14-item self-administered questionnaire which is routinely used in clinical trials to assess pain severity and pain interference with daily activities in patients with cancer. Pain severity is assessed by four items including pain at its "worst", "least", "average" in the last 24 hours and "now" (current pain), each item being rated on a 0-10 scale.

Time frame: Up to 24 weeks after randomization

Secondary Outcomes

Fatigue

Fatigue will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

QoL: Physical scale (EORTC QLQ-C30)

Physical scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

QoL: Rose scale (EORTC QLQ-C30)

Role scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

QoL: Emotional scale (EORTC QLQ-C30)

Emotional scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Data from ClinicalTrials.gov

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Kantonsspital Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

CABA - Zentrum für Onkologie, Psychologie und Bewegung

Basel, Switzerland

Brustzentrum Basel - Praxis für ambulante Tumortherapie

Basel, Switzerland

Universitätsspital Basel

Basel, Switzerland

Inselspital Bern

Bern, Switzerland

Hirslanden Brustzentrum Bern Biel

Bern, Switzerland

Clinique des Grangettes, Centre du sein

Chêne-Bougeries, Switzerland

Kantonsspital Graubünden

Chur, Switzerland

Tumorzentrum ZeTuP Chur

Chur, Switzerland

...and 22 more locations

QoL: Cognitive scale (EORTC QLQ-C30)

Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

QoL: Social functioning scale (EORTC QLQ-C30)

Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Nausea/Vomiting

Nausea/vomiting will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Pain (EORTC QLQ-C30)

Pain will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Global health status

Global health status will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Dyspnoea

Dyspnoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Insomnia

Insomnia will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Appetite loss

Appetite loss will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Constipation

Constipation will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Diarrhoea

Diarrhoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Financial difficulties

Financial difficulties will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Hot flashes

Hot flashes will be assessed at baseline, during intervention phase and during follow-up phase via the item 37 of the EORTC QLQ BR-23.

Time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Intensity of muscle or joint pain/stiffness and its impact on everyday functioning

Severity of muscle or joint pain/stiffness will be measured by the four BPI pain severity items. Pain interference will be calculated as the mean of the seven interference items.

Time frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization

Walking activity

During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.

Time frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization

AI treatment adherence (diary)

Adherence will be assessed by patient self-report (diary).

Time frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks.

AI treatment adherence (questionnaire)

Adherence will be assessed by patient self-report (questionnaire completed at visits).

Time frame: Baseline, 12, 24 weeks and 1, 2 years after randomization