Resistance-type Exercise Training in Postmenopausal Women Survivors of Breast Cancer

NCT05690295 | Completed DMC

• 1 other identifier: DFP22-0020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In postmenopausal women, an alteration in body composition occurs as a consequence of the secretion of low levels of serum estrogens by the ovaries. Observing an increase in abdominal and mammary fat mass and a decrease in skeletal muscle mass, which is also accompanied by loss of muscle strength and physical function, which leads early to a sarcopenia. On the other hand, the increase in estrogen production by adipose tissue has been associated with an increased risk of breast cancer during menopause because the mammary parenchyma is particularly sensitive to this type of estrogen. For this reason, Hormone Therapy (Aromatase Inhibitors and Tamoxifen) is prescribed in women with estrogen receptor-positive breast cancer. Antineoplastic treatments (Chemotherapy and Hormonal Therapy) have contributed to non-metastatic breast cancer currently presenting a high survival rate, not without adverse effects associated with the course of the disease, age and antineoplastic treatment, affecting various systems, but particularly skeletal muscle mass. Therefore, resistance exercise training has been proposed as an effective intervention strategy to increase muscle mass and strength in different populations. However, the level of muscle response to this type of training in postmenopausal women survivors of breast cancer with and without hormone treatment (Aromatase Inhibitors and Tamoxifen) is unknown.

Conditions

Breast Cancer Survivors; Postmenopause; Resistance Training

Keywords

breast cancer; hormone therapy; exercise; muscle mass; strength

Outcome Measures

Primary Outcomes (1)

• The changes in skeletal muscle thickness, including measurements for the biceps, triceps brachii, rectus femoris, vastus intermedius, and the total quadriceps, will be assessed using muscular ultrasound after prolonged resistance-type exercise training

  Measurements will be in centimeters.

  Before, and after 12 weeks of training

Secondary Outcomes (8)

• Change in kilograms of the arms strength measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training

  Before, and after 12 weeks of training

• Change in kilograms of the legs strength measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training

  Before, and after 12 weeks of training

• Change in kilograms of the hand grip strength measured via JAMAR handheld dynamometer after prolonged resistance-type exercise training

  Before, and after 12 weeks of training

• Change in points of the physical performance measured via Short physical performance battery (SPPB) after prolonged resistance-type exercise training

  Before, and after 12 weeks of training

• Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) after prolonged resistance-type exercise training

  Before, and after 12 weeks of training

Study Arms (2)

CLIMHEALTHY

EXPERIMENTAL

All postmenopausal women without breast cancer will be subjected to 12 weeks of full body resistance exercise training (3 times per week)

Other: Prolonged resistance-type exercise training

CLIMCANCER

EXPERIMENTAL

All postmenopausal women survivors of breast cancer without or with Hormone Therapy (pecifically Aromatase Inhibitor or Tamoxifen) will be subjected to 12 weeks of full body resistance exercise training (3 times per week)

Other: Prolonged resistance-type exercise training

Interventions

Prolonged resistance-type exercise training OTHER

All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk).

CLIMCANCER; CLIMHEALTHY

Eligibility Criteria

• Age: 45 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy postmenopausal women and postmenopausal women survivors of breast cancer with and without Hormonal Therapy (Aromatase Inhibitors and Tamoxifen) between 45 to 59 years.
• Women survivors of breast cancer with active Hormone Therapy in the last 12 months.
• Women breast cancer survivors with luminal molecular profile and positive estrogen receptors.
• Body mass index 18.5 \< BMI \< 30 kg/m2.
• Volunteers without cognitive impairment (abbreviated Minimental \>13 points).

You may not qualify if:

• Active antineoplastic treatment in the last 12 months.
• \>200 mL of volume difference between upper limbs and/or stage IV breast cancer.
• Performing regular resistance training (2 or more times per week, carrying out progressive training) in the previous 6 months.
• Cardiovascular diseases that are contradictory for physical activity (not included controlled Hypertension).
• All co-morbidities interacting with mobility and muscle metabolism of the body and that do not allow to (safely) perform the resistance-type exercise training (e.g. debilitating arthritis, spasticity/rigidity, all neurological disorders and paralysis).

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile

Temuco, Chile

Location

Related Publications (2)

• Artigas-Arias M, Munoz-Cofre R, Vidal-Seguel N, Alegria-Molina A, Sapunar J, Curi R, Marzuca-Nassr GN. Resistance exercise training similarly improves work efficiency and measured submaximal oxygen consumption during the 6-min walk test in healthy postmenopausal women and breast cancer survivors. Eur J Appl Physiol. 2025 Sep 16. doi: 10.1007/s00421-025-05966-0. Online ahead of print.

  PMID: 40954340 DERIVED

• Artigas-Arias M, Alegria-Molina A, Vidal-Seguel N, Munoz-Cofre R, Carranza-Leiva J, Sepulveda-Lara A, Vitzel KF, Huard N, Sapunar J, Salazar LA, Curi R, Marzuca-Nassr GN. Skeletal muscle mass, strength, and physical performance gains are similar between healthy postmenopausal women and postmenopausal breast cancer survivors after 12 weeks of resistance exercise training. Support Care Cancer. 2024 Nov 23;32(12):818. doi: 10.1007/s00520-024-08973-7.

  PMID: 39579274 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Gabriel N Marzuca-Nassr

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 19, 2023
• Study Start: March 22, 2023
• Primary Completion: March 29, 2024
• Study Completion: May 15, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)