Activity Program During Aromatase Inhibitor Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 10 July 2023
• Main ID: NCT03786198
• Date of registration: 14/12/2018
• Prospective Registration: Yes
• Primary sponsor: Swiss Group for Clinical Cancer Research
• Public title: Activity Program During Aromatase Inhibitor Therapy
• Scientific title: A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial
• Date of first enrolment: March 28, 2019
• Target sample size: 375
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03786198
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Friedemann Honecker, MD
• Affiliation: Tumor- und Brustzentrum ZeTuP St.Gallen

• Name: Nicolette Hoefnagels, MSc
• Affiliation: Tumor- und Brustzentrum ZeTuP St.Gallen

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Early Breast Cancer

Intervention(s)

Behavioral: Activity program

Behavioral: Control

Primary Outcome(s)

Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score [Time Frame: Up to 24 weeks after randomization]

Secondary Outcome(s)

AI treatment adherence (diary) [Time Frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks.]

Appetite loss [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Hot flashes [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Nausea/Vomiting [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Pain (EORTC QLQ-C30) [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

QoL: Emotional scale (EORTC QLQ-C30) [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Constipation [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Global health status [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Financial difficulties [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

QoL: Physical scale (EORTC QLQ-C30) [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Diarrhoea [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

QoL: Social functioning scale (EORTC QLQ-C30) [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

AI treatment adherence (questionnaire) [Time Frame: Baseline, 12, 24 weeks and 1, 2 years after randomization]

Dyspnoea [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Walking activity [Time Frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization]

Fatigue [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

QoL: Rose scale (EORTC QLQ-C30) [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 [Time Frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization]

Insomnia [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

QoL: Cognitive scale (EORTC QLQ-C30) [Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization]

Secondary ID(s)

SAKK 95/17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors