Analgesic Effect of Resistance Training for Breast Cancer Survivors

NCT ID: NCT04509284

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2021-09-23

Brief Summary

Persistent pain after treatment for breast cancer is a major clinical problem, affecting 25-60 % of the patients and is a source of considerable physical disability and psychological distress. Thus, the development of novel interventions to improve pain management for these patients is of clinical importance. Resistance training (RT) is a promising tool to combat a variety of undesirable adverse effects due to breast cancer treatment. Further, research suggests that it may also be able to provide pain-relieving benefits.

Hypothesis: Resistance training will improve pain perception and physical function in the short- and long term compared to a non-training control group.

Detailed Description

Breast cancer is the most common cancer in women worldwide with more than a million new cases diagnosed every year [1]. Fortunately, due to better treatment options, the population of long-term survivors is increasing. This poses new demands for knowledge on how to manage late effects to the treatment regimen. Persistent pain after treatment for breast cancer is a common and underestimated problem as well as it can be a source of considerable physical disability and psychological distress [2]. Hence, the development of novel interventions to improve pain management is of high clinical relevance. Resistance training (RT) is a promising clinical therapeutic tool to improve a variety of adverse effects to breast cancer treatment [3] and may provide several pain-relieving benefits [4]. However, the efficacy of this modality for managing persistent pain after breast cancer treatment is currently unclear. Therefore, the purpose of this project is to investigate if individualized RT can modulate persistent pain after breast cancer treatment, thereby improving our understanding of how this modality may benefit patients and contribute to clinical guidelines for pain management in this clinical population.

Conditions

Breast Cancer; Surgery; Chemotherapy Effect; Radiotherapy Side Effect; Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Training

Participants with persistent pain after breast cancer treatment will receive 24 sessions of individualized progressive total body resistance training, supervised by a certified strength and conditioning specialist.

Group Type: EXPERIMENTAL

Training

Intervention Type: OTHER

The experimental group will perform a supervised progressive resistance training program, with five exercises for the upper- and lower body (box squat, bench press, trap bar deadlift, bench pull and lat pulldown), 2x/week for a 12 week period. The program will utilize a flexible progression system through three distinct training phases; 1) 2-4 sets of 10-12 repetitions, 2) 2-4 sets of 6-8 repetitions, 3) 2-4 sets of 2-4 repetitions. Number of sets are adjusted within session according to daily readiness while load is adjusted within and between sessions according to number of reps performed. A 3-5min rest period is provided throughout the program.

Control

Participants with persistent pain after breast cancer treatment will be instructed to continue their everyday lifestyle and be encouraged not to engage in new forms of exercise or physical activity throughout the study period.

Group Type: OTHER

Control

Intervention Type: OTHER

The control group will be instructed to continue their everyday lifestyle with no specific instruction regarding exercise and/or diet. However, they will be encouraged not to engage in new forms of exercise or physical activity throughout the study period.

Interventions

Training

The experimental group will perform a supervised progressive resistance training program, with five exercises for the upper- and lower body (box squat, bench press, trap bar deadlift, bench pull and lat pulldown), 2x/week for a 12 week period. The program will utilize a flexible progression system through three distinct training phases; 1) 2-4 sets of 10-12 repetitions, 2) 2-4 sets of 6-8 repetitions, 3) 2-4 sets of 2-4 repetitions. Number of sets are adjusted within session according to daily readiness while load is adjusted within and between sessions according to number of reps performed. A 3-5min rest period is provided throughout the program.

Intervention Type: OTHER

Control

The control group will be instructed to continue their everyday lifestyle with no specific instruction regarding exercise and/or diet. However, they will be encouraged not to engage in new forms of exercise or physical activity throughout the study period.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• primary diagnosis of breast cancer (grades I-IIIA).
• adult women at least 18 years of age.
• having received breast cancer treatment (i.e. surgery and possible adjuvant chemo and/or radiotherapy) at least 18 months before the start of the study.
• self reported pain in the areas of the breast, shoulder, axilla, arm and/or side of body with an intensity of ≥ 3 on a numeric rating scale (0 = no pain, 10 = worst pain imaginable).
• no signs of cancer recurrence.
• reading, writing and speaking Danish.

Exclusion Criteria

• breast surgery for cosmetic reasons or prophylactic mastectomy.
• bilateral breast cancer.
• lymphedema.
• other chronic pain conditions (e.g., rheumatoid arthritis).
• previous diagnosis of fibromyalgia syndrome.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Danish Cancer Society

OTHER

Sponsor Role: collaborator

Danish Cancer Survivor and Late Effects Group

UNKNOWN

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Gorm Henrik Fogh Rasmussen

Ph.D.-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pascal Madeleine, Dr. Scient

Role: STUDY_CHAIR

Aalborg University

Michael Voigt, Ph. D.

Role: STUDY_CHAIR

Aalborg University

Mathias Kristiansen, Ph. D.

Role: STUDY_CHAIR

Aalborg University

Manuel Arroyo-Morales, Dr. Med

Role: STUDY_CHAIR

Universidad de Granada

Locations

Department of Health Science and Technology, Aalborg University

Aalborg, Northern Jutland, Denmark

Countries

Denmark

References

Cronin-Fenton DP, Norgaard M, Jacobsen J, Garne JP, Ewertz M, Lash TL, Sorensen HT. Comorbidity and survival of Danish breast cancer patients from 1995 to 2005. Br J Cancer. 2007 May 7;96(9):1462-8. doi: 10.1038/sj.bjc.6603717. Epub 2007 Apr 3.

Reference Type: BACKGROUND

PMID: 17406360 (View on PubMed)

Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.

Reference Type: BACKGROUND

PMID: 12855309 (View on PubMed)

De Backer IC, Schep G, Backx FJ, Vreugdenhil G, Kuipers H. Resistance training in cancer survivors: a systematic review. Int J Sports Med. 2009 Oct;30(10):703-12. doi: 10.1055/s-0029-1225330. Epub 2009 Jul 7.

Reference Type: BACKGROUND

PMID: 19585401 (View on PubMed)

Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21.

Reference Type: BACKGROUND

PMID: 30904519 (View on PubMed)

Rasmussen GHF, Madeleine P, Arroyo-Morales M, Voigt M, Kristiansen M. Resistance Training-Induced Acute Hypoalgesia in Women With Persistent Pain After Breast Cancer Treatment. J Strength Cond Res. 2023 Mar 1;37(3):e16-e24. doi: 10.1519/JSC.0000000000004320. Epub 2022 Sep 28.

Reference Type: DERIVED

PMID: 36173261 (View on PubMed)

Rasmussen GHF, Kristiansen M, Arroyo-Morales M, Voigt M, Madeleine P. The Analgesic Effect of Resistance Training after Breast Cancer (ANTRAC): A Randomized Controlled Trial. Med Sci Sports Exerc. 2023 Feb 1;55(2):167-176. doi: 10.1249/MSS.0000000000003034. Epub 2022 Sep 7.

Reference Type: DERIVED

PMID: 36084228 (View on PubMed)

Other Identifiers

R204-A12469

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N-20180090

Identifier Type: -

Identifier Source: org_study_id