Analgesic Effect of Resistance Training for Breast Cancer Survivors

NCT04509284 | Completed DMC

• 2 other identifiers: N-20180090R204-A12469
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Persistent Pain; Breast cancer treatment; Physical function; Quality of life; Resistance training; Analgesic effect of resistance training of persistent pain after breast cancer (ANTRAC)

Outcome Measures

Primary Outcomes (2)

• Change in pain sensitivity, assessed through pressure pain thresholds.

  Between group comparisons of treatment effect (change in pressure pain thresholds) from baseline to follow-up) will be performed. Pressure pain thresholds will be collected with a pressure algometer with a progressive increment in pressure of 30kPa.

  Baseline and at 3, and 6 months

• Change in pain intensity, assessed through a 11 point numeric rating scale (0 = no pain, 10 = worst pain imaginable).

  Pain intensity is collected in two different contexts; 1) recollection for the past 3 months and 2) movement evoked pain during testing and training.

  Baseline and at 3, and 6 months

Secondary Outcomes (9)

• Muscular strength assesses through a 1 repetition maximum (1RM)

  Baseline and at 3, and 6 months

• Active shoulder range of motion assessed with a universal goniometer.

  Baseline and at 3, and 6 months

• Body composition assessed through bioelectrical impedance measurements.

  Baseline and at 3, and 6 months

• Arm circumference measured bilaterally at a single point 30cm above the styloid process.

  Baseline and at 3, and 6 months

• Physical activity level assessed through the international physical activity questionnaire (IPAQ).

  Baseline and at 3, and 6 months

Other Outcomes (2)

• Summative process evaluation

  At 3 months

• Training log, collecting daily readiness for exertion, performance, perceived exertion level and movement evoked pain.

  Every session for 12 weeks.

Study Arms (2)

Training

EXPERIMENTAL

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.

Other: Training

Control

OTHER

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.

Other: Control

Interventions

Training 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.

Training

Control 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.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead
• Danish Cancer Society: collaborator
• Danish Cancer Survivor and Late Effects Group: collaborator
• Universidad de Granada: collaborator

Study Sites (1)

Department of Health Science and Technology, Aalborg University

Aalborg, Northern Jutland, 9220, Denmark

Location

Related Publications (6)

• 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.

  PMID: 17406360 BACKGROUND

• 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.

  PMID: 12855309 BACKGROUND

• 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.

  PMID: 19585401 BACKGROUND

• 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.

  PMID: 30904519 BACKGROUND

• 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.

  PMID: 36173261 DERIVED

• 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.

  PMID: 36084228 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pascal Madeleine, Dr. Scient

  Aalborg University

  STUDY CHAIR

• Michael Voigt, Ph. D.

  Aalborg University

  STUDY CHAIR

• Mathias Kristiansen, Ph. D.

  Aalborg University

  STUDY CHAIR

• Manuel Arroyo-Morales, Dr. Med

  Universidad de Granada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor) The statistician, who will conduct the statistical analysis, will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.-student

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 12, 2020
• Study Start: August 10, 2020
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)