Clinical trial NCT04509284: Analgesic Effect of Resistance Training for Breast Cancer Survivors
Official title: Effect of Resistance Training of Persistent Pain After Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Danish Cancer Survivor and Late Effects Group
name: Universidad de Granada
First posted: 2020-08-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in pain sensitivity, assessed through pressure pain thresholds.
timeFrame: Baseline and at 3, and 6 months
measure: Change in pain intensity, assessed through a 11 point numeric rating scale (0 = no pain, 10 = worst pain imaginable).
timeFrame: Baseline and at 3, and 6 months
Secondary outcomes:
measure: Muscular strength assesses through a 1 repetition maximum (1RM)
timeFrame: Baseline and at 3, and 6 months
measure: Active shoulder range of motion assessed with a universal goniometer.
timeFrame: Baseline and at 3, and 6 months
measure: Body composition assessed through bioelectrical impedance measurements.
timeFrame: Baseline and at 3, and 6 months
measure: Arm circumference measured bilaterally at a single point 30cm above the styloid process.
timeFrame: Baseline and at 3, and 6 months
measure: Physical activity level assessed through the international physical activity questionnaire (IPAQ).
timeFrame: Baseline and at 3, and 6 months
measure: Health related quality of life assessed through the European Organisation for Research and Treatment of Cancer (EORCT)-C30 quality of life questionaire
timeFrame: Baseline and at 3, and 6 months
measure: Quality of life assessed through the breast cancer specific European Organisation for Research and Treatment of Cancer (EORCT)-BR23 quality of life questionaire
timeFrame: Baseline and at 3, and 6 months
measure: Cancer fatigue assessed through the Functional Assessment of Chronic Illness Therapy (FACIT) - fatigue scale.
timeFrame: Baseline and at 3, and 6 months
measure: Mental health assessed through the Major Depression Index (MDI)
timeFrame: Baseline and at 3, and 6 months
Other outcomes:
measure: Summative process evaluation
timeFrame: At 3 months
measure: Training log, collecting daily readiness for exertion, performance, perceived exertion level and movement evoked pain.
timeFrame: Every session for 12 weeks.
Locations:
city: Aalborg
country: Denmark
facility: Department of Health Science and Technology, Aalborg University
state: Northern Jutland
Study officials:
affiliation: Aalborg University
name: Pascal Madeleine, Dr. Scient
role: STUDY_CHAIR
affiliation: Aalborg University
name: Michael Voigt, Ph. D.
role: STUDY_CHAIR
affiliation: Aalborg University
name: Mathias Kristiansen, Ph. D.
role: STUDY_CHAIR
affiliation: Universidad de Granada
name: Manuel Arroyo-Morales, Dr. Med
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.