Breast Cancer(ANTRAC)NCT04509284
Analgesic Effect of Resistance Training for Breast Cancer Survivors
A study testing Training in people with Breast Cancer and Surgery, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Surgery, Chemotherapy Effect
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Aug 2020to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Health Science and Technology, Aalborg University
Aalborg, Northern Jutland, 9220
About this study
Official title: Effect of Resistance Training of Persistent Pain After Breast Cancer
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.
Read the 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.
- Being tested
- Training, Control
- 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)
- Medical subject headings
- Breast Neoplasms, Radiation Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and at 3, and 6 months
Secondary outcomes (9)
Muscular strength assesses through a 1 repetition maximum (1RM)
1RM box squat, bench press, trapbar deadlift, bench pull and lat pulldown conducted in accordance with the recommendations of the American College of Sports Medicine (ACSM)
Measured: Baseline and at 3, and 6 months
Active shoulder range of motion assessed with a universal goniometer.
Active range of motion for the affected shoulder is collected for shoulder flexion, horizontal shoulder flexion/extension, shoulder abduction and internal/external shoulder/rotation
Measured: Baseline and at 3, and 6 months
Body composition assessed through bioelectrical impedance measurements.
Estimates of body fat mass, fat free mass, skeletal muscle mass and bodyfat percentage are collected from bioelectrical impedance using an InBody370 device.
Measured: Baseline and at 3, and 6 months
Arm circumference measured bilaterally at a single point 30cm above the styloid process.
Arm circumference is collected to assess potential lymphedema development. A difference in circumference of >10% between arms is considered indicative of lymphedema.
Measured: Baseline and at 3, and 6 months
Physical activity level assessed through the international physical activity questionnaire (IPAQ).
IPAQ estimates physical activity level as "low", "moderate" or "high" from the number of days and time per day conducting either hard, moderate or easy physical activity for the pas seven days.
Measured: Baseline and at 3, and 6 months
Health related quality of life assessed through the European Organisation for Research and Treatment of Cancer (EORCT)-C30 quality of life questionaire
The EORCT-C30 QLQ estimates quality of life through a series of questions regarding the extent to which the respondee experience various restrictions in physical function and well-being common in cancer patients, ranging from 1 (not at all) to 4 (A lot) on a four point likert scale.
Measured: Baseline and at 3, and 6 months
Quality of life assessed through the breast cancer specific European Organisation for Research and Treatment of Cancer (EORCT)-BR23 quality of life questionaire
The EORCT-C30 QLQ estimates quality of life through a series of questions regarding the extent to which the respondee experience various restrictions in physical function and well-being common in breast cancer patients, ranging from 1 (not at all) to 4 (A lot) on a four point likert scale.
Measured: Baseline and at 3, and 6 months
Cancer fatigue assessed through the Functional Assessment of Chronic Illness Therapy (FACIT) - fatigue scale.
The FACIT-scale estimates fatigue through a series of questions regarding the extent to which the respondee experience various symptoms of fatigue, ranging from 0 (not at all) to 4 (A lot) on a five point likert scale.
Measured: Baseline and at 3, and 6 months
Mental health assessed through the Major Depression Index (MDI)
The MDI estimates mental health through a series of questions regarding the extent to which the respondee experience various symptoms of depression, ranging from 0 (never) to 5 (All the time) on a five point likert scale.
Measured: Baseline and at 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start10 Aug 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Danish Cancer Survivor and Late Effects Group, Universidad de Granada
- Responsible party
- Principal investigator, Gorm Henrik Fogh Rasmussen, Aalborg University
- Investigators
- Pascal Madeleine, Dr. Scient, Study chair, Aalborg UniversityMichael Voigt, Ph. D., Study chair, Aalborg UniversityMathias Kristiansen, Ph. D., Study chair, Aalborg UniversityManuel Arroyo-Morales, Dr. Med, Study chair, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509284
- Sponsor's protocol ID
- N-20180090
- Other IDs
- R204-A12469
- Acronym
- (ANTRAC)
- Status last verified
- Jan 2022
- First submitted
- 6 Aug 2020
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17406360Jung 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.
PubMed 12855309De 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.
PubMed 19585401Rice 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.
PubMed 30904519Rasmussen 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.
PubMed 36173261Rasmussen 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.
PubMed 36084228
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training of Persistent Pain After Breast Cancer
- ClinicalTrials.gov ID
- NCT04509284
- Acronym / sponsor ID
- (ANTRAC) / N-20180090
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Danish Cancer Survivor and Late Effects Group, Universidad de Granada
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: TrainingParticipants 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. |
| Control | Other | Other: ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingThe 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. | Other | Training |
| ControlThe 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. | Other | Control |
Primary outcome
Change in pain sensitivity, assessed through pressure pain thresholds.
Time frame: Baseline and at 3, and 6 months
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.
Change in pain intensity, assessed through a 11 point numeric rating scale (0 = no pain, 10 = worst pain imaginable).
Time frame: Baseline and at 3, and 6 months
Pain intensity is collected in two different contexts; 1) recollection for the past 3 months and 2) movement evoked pain during testing and training.
9 secondary outcomes
Muscular strength assesses through a 1 repetition maximum (1RM)
Time frame: Baseline and at 3, and 6 months
Active shoulder range of motion assessed with a universal goniometer.
Time frame: Baseline and at 3, and 6 months
Body composition assessed through bioelectrical impedance measurements.
Time frame: Baseline and at 3, and 6 months
Arm circumference measured bilaterally at a single point 30cm above the styloid process.
Time frame: Baseline and at 3, and 6 months
Physical activity level assessed through the international physical activity questionnaire (IPAQ).
Time frame: Baseline and at 3, and 6 months
Health related quality of life assessed through the European Organisation for Research and Treatment of Cancer (EORCT)-C30 quality of life questionaire
Time frame: Baseline and at 3, and 6 months
Quality of life assessed through the breast cancer specific European Organisation for Research and Treatment of Cancer (EORCT)-BR23 quality of life questionaire
Time frame: Baseline and at 3, and 6 months
Cancer fatigue assessed through the Functional Assessment of Chronic Illness Therapy (FACIT) - fatigue scale.
Time frame: Baseline and at 3, and 6 months
Mental health assessed through the Major Depression Index (MDI)
Time frame: Baseline and at 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Background: PubMed 17406360Cronin-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.
- Background: PubMed 12855309Jung 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.
- Background: PubMed 19585401De 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.
- Background: PubMed 30904519Rice 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.
- Derived from this study: PubMed 36173261Rasmussen 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.
- Derived from this study: PubMed 36084228Rasmussen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Madeleine, Dr. Scient study chair
Aalborg University
Michael Voigt, Ph. D. study chair
Aalborg University
Mathias Kristiansen, Ph. D. study chair
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Breast Cancer and Surgery, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain sensitivity, assessed through pressure pain thresholds. (time frame: Baseline and at 3, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509284, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.