Chronic PainNCT05713786
Physical Exercise, Motor Activity and Post-mastectomy Pain Syndrome.
An observational study of Chronic Pain, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
Trial summary
Pain is an unpleasant sensation common to all those who undergo surgery. Several studies indicate that 40-60% of patients experience the post-operative experience and can be caused by both internal and external stimuli. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pain
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 30 Sep 2022
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women underwent unilateral or bilateral mastectomy due to resection of stage II and III breast cancer.
Who may be able to join
- over the age of 18 with a diagnosis of previous Stages I-III breast cancer.
Who cannot join
- medical history of other types of cancer;
- disease related to the immune system (e.g. multiple sclerosis, HIV, lupus);
- recent symptoms of illness (cough, fever);
- waiting breast reconstruction;
- not chemotherapy or radiation during the first six months after surgery:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Exercise and Motor Activity on Post-mastectomy Pain.
Pain is an unpleasant sensation common to all those who undergo surgery. Several studies indicate that 40-60% of patients experience the post-operative experience and can be caused by both internal and external stimuli. The most patients define the post-operative experience as a very painful condition that interferes with normal daily activities. Chronic post mastectomy pain is a condition characterized by pain in the anterior chest, armpit, and/or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery. It can become chronic in a broad spectrum of conditions. In fact, it is estimated that between 10 and 50% of elective interventions can generate persistent post-surgical pain.
Aim of this prospective observational study is to evaluate the effects of motor and/or sports activity on the intensity and interference of chronic pain in quality of life of women underwent mastectomy.
Read the detailed description
Acute post surgery pain is defined as a normal physiological response to an injurious stimulus.
Adequate monitoring associated with appropriate postoperative pain therapy significantly contribute to the improvement of perioperative morbidity, assessed in terms of lower incidence of postoperative complications. In addition, many patients undergo important changes in emotional and affective behavior: acute pain anxiety is often replaced by reactive depression and hypochondria combined with somatization and worsening of quality of life. The latter is an important factor in the context of tumor pathology. Since, while the goal of achieving 100% survival in women with breast cancer is still pursued, so too is improving the quality of life and restoring optimal levels of function of patients.The benefits of physical activity on the general population have been extensively studied. It has been shown that physical activity in the cancer patient allows the recovery of the previous functional capacities, strength and flexibility, improvement of the pain symptom and asthenia, as well as the reduction of alterations in the haematological picture such as neutropenia, anemia, thrombocytopenia.
Breast cancer is due to the uncontrolled multiplication of certain cells in the mammary gland which turn into malignant cells. The most frequent tumors arise from glandular cells (lobules) or from those that form the wall of the ducts.
Breast cancers can be invasive or non-invasive. The most invasive forms are usually ductal carcinoma, which affects the milk ducts beyond the duct wall and accounts for 70-80 percent of all forms of breast cancer, and lobular carcinoma that exceeds the wall of the lobule. Breast cancer is classified into 5 stages (0 to IV).
Chronic post mastectomy pain is a condition characterized by pain in the front of the chest, armpit, and / or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery (International Association for the Study of Pain.
In cancer patients, the level of pain intensity can be used in pain management as a subjective indicator to be quantitatively assessed together with what is defined as "interference of pain in activities of daily living". Interference is a key biomarker for establishing adequate pain therapy. Pain intensity and interference are both measured using questionnaires / scales such as the Numerical Rating Scale (NRS), the Brief Pain Inventory (BPI).
Finally, inflammatory responses and oxidative balance play key roles in the development and persistence of many pathological pain states. In light of the above, a prospective observational clinical study is proposed in order to evaluate the influence of motor activity on the intensity and interference of chronic pain in women who have undergone mastectomy surgery due to resection of stage breast cancer. II and III.
Study population: women underwent unilateral or bilateral mastectomy due to resection of stage II and III breast cancer not followed by breast reconstruction aged 18 years or older who have not received chemotherapy or radiation.
Pain assessment Pain assessment is a multidimensional process, which must take into account all the components of suffering, both physically, psychologically and socially. The assessment of pain and motor activity of each participant in the study will be carried out 3 and 6 months after surgery. Pain will be assessed by administration of the following questionnaires: Numerical Rating Scale, Brief Inventory Pain.
The IPAQ (International Physical Activity Questionnaire) questionnaire measures the type and amount of physical activity that is normally done. The questions refer to the activity carried out in the last 7 days. It will be administered at 3 and 6 months after surgery.The expected duration of the study can be considered to be approximately 12 months.
Interference is a key biomarker for establishing adequate pain therapy. Pain intensity and interference will be both measured using questionnaires/scales such as the numerical Rating scale (NRS), the Brief Pain Inventory (BPI) will be assessed 12 and 24 weeks after mastectomy by administration of the following questionnaires: Numerical Rating Scale, Brief Inventory Pain. Physical activity will be assessed by means of the IPAQ questionnaire (International Physical Activity.
At the same timepoints (12 and 24 weeks after surgery) biomarkers of pain, inflammation (C-reactive protein, Interleukin-6, interleukin-8, tumor necrosis factor-alpha) and oxidative stress (superoxide dismutase, catalase and malondyaldheide) will be measured together with routinary blood parameters.
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Post mastectomy pain syndrome, Motor activity, Pain markers
- Medical subject headings
- Chronic Pain, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.
Pain intensity self-measured using the Numerical Rating Scale (NRS). NRS is a 0-11 point-scale where the end points are the extremes of no pain (point 0) and worst pain as bad as it could be (point 10).
Measured: Evaluation performed three and six months after surgery
Effects of motor and/or sports activity on interference of chronic pain in women underwent mastectomy.
Interference of pain in activities of daily living is a key biomarker for establishing adequate pain therapy. Interference of pain measured with the Brief Pain Inventory - Short Form. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily activities. Each item is scored on a 10 point numeric rating scale where 0 = no interference/pain and 10 = severe or complete interference/pain.
Measured: Evaluation performed three and six months after surgery
Secondary outcomes (2)
Biomarkers of inflammation.
Biomarkers of inflammation were evaluated in serum. Analysis was performed in blood aliquot withdrawn during the routinary exames. The following biomarkers were considered: C reactive protein (CRP), was evaluated by cytofluorimetry; intrleukin 6 (IL6), interleukin 8 (IL8), tumor necrosis factor alpha (TNFa) were evaluated by ELISA.
Measured: Evaluation performed three and six months after surgery
Biomarkers of oxidative stress
Biomarkers of oxidative stress were evaluated in serum. Analysis was performed in blood aliquot withdrawn during the routinary exames. The following biomarkers of oxidative stress were considered: superoxide dismutase (SOD), catalase (CAT) and manlondialdheyde (MDA). SOD and CAT activity was evaluated by colorimetric assay, MDA by ELISA.
Measured: Evaluation performed three and six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Sep 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gioacchino Calapai, MD, Study director, Azienda Ospedaliera Universitaria "G. Martino"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713786
- Sponsor's protocol ID
- BRCAMA
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Calapai M, Esposito E, Puzzo L, Vecchio DA, Blandino R, Bova G, Quattrone D, Mannucci C, Ammendolia I, Mondello C, Gangemi S, Calapai G, Cardia L. Post-Mastectomy Pain: An Updated Overview on Risk Factors, Predictors, and Markers. Life (Basel). 2021 Sep 29;11(10):1026. doi: 10.3390/life11101026.
PubMed 34685397Ambrose KR, Golightly YM. Physical exercise as non-pharmacological treatment of chronic pain: Why and when. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):120-30. doi: 10.1016/j.berh.2015.04.022. Epub 2015 May 23.
PubMed 26267006Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
PubMed 21621130Tait RC, Zoberi K, Ferguson M, Levenhagen K, Luebbert RA, Rowland K, Salsich GB, Herndon C. Persistent Post-Mastectomy Pain: Risk Factors and Current Approaches to Treatment. J Pain. 2018 Dec;19(12):1367-1383. doi: 10.1016/j.jpain.2018.06.002. Epub 2018 Jun 30.
PubMed 29966772Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
PubMed 30586070Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.
PubMed 3461421Schug SA, Bruce J. Risk stratification for the development of chronic postsurgical pain. Pain Rep. 2017 Oct 31;2(6):e627. doi: 10.1097/PR9.0000000000000627. eCollection 2017 Nov.
PubMed 29392241Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.
PubMed 17426506Kaushik AS, Strath LJ, Sorge RE. Dietary Interventions for Treatment of Chronic Pain: Oxidative Stress and Inflammation. Pain Ther. 2020 Dec;9(2):487-498. doi: 10.1007/s40122-020-00200-5. Epub 2020 Oct 21.
PubMed 33085012
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise and Motor Activity on Post-mastectomy Pain.
- ClinicalTrials.gov ID
- NCT05713786
- Acronym / sponsor ID
- BRCAMA
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Post mastectomy pain syndrome, Motor activity, Pain markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Feb 2023 (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.
Pain is an unpleasant sensation common to all those who undergo surgery. Several studies indicate that 40-60% of patients experience the post-operative experience and can be caused by both internal and external stimuli. The most patients define the post-operative experience as a very painful condition that interferes with normal daily activities. Chronic post mastectomy pain is a condition characterized by pain in the anterior chest, armpit, and/or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery. It can become chronic in a broad spectrum of conditions. In fact, it is estimated that between 10 and 50% of elective interventions can generate persistent post-surgical pain.
Aim of this prospective observational study is to evaluate the effects of motor and/or sports activity on the intensity and interference of chronic pain in quality of life of women underwent mastectomy.
Detailed description
Acute post surgery pain is defined as a normal physiological response to an injurious stimulus.
Adequate monitoring associated with appropriate postoperative pain therapy significantly contribute to the improvement of perioperative morbidity, assessed in terms of lower incidence of postoperative complications. In addition, many patients undergo important changes in emotional and affective behavior: acute pain anxiety is often replaced by reactive depression and hypochondria combined with somatization and worsening of quality of life. The latter is an important factor in the context of tumor pathology. Since, while the goal of achieving 100% survival in women with breast cancer is still pursued, so too is improving the quality of life and restoring optimal levels of function of patients.The benefits of physical activity on the general population have been extensively studied. It has been shown that physical activity in the cancer patient allows the recovery of the previous functional capacities, strength and flexibility, improvement of the pain symptom and asthenia, as well as the reduction of alterations in the haematological picture such as neutropenia, anemia, thrombocytopenia.
Breast cancer is due to the uncontrolled multiplication of certain cells in the mammary gland which turn into malignant cells. The most frequent tumors arise from glandular cells (lobules) or from those that form the wall of the ducts.
Breast cancers can be invasive or non-invasive. The most invasive forms are usually ductal carcinoma, which affects the milk ducts beyond the duct wall and accounts for 70-80 percent of all forms of breast cancer, and lobular carcinoma that exceeds the wall of the lobule. Breast cancer is classified into 5 stages (0 to IV).
Chronic post mastectomy pain is a condition characterized by pain in the front of the chest, armpit, and / or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery (International Association for the Study of Pain.
In cancer patients, the level of pain intensity can be used in pain management as a subjective indicator to be quantitatively assessed together with what is defined as "interference of pain in activities of daily living". Interference is a key biomarker for establishing adequate pain therapy. Pain intensity and interference are both measured using questionnaires / scales such as the Numerical Rating Scale (NRS), the Brief Pain Inventory (BPI).
Finally, inflammatory responses and oxidative balance play key roles in the development and persistence of many pathological pain states. In light of the above, a prospective observational clinical study is proposed in order to evaluate the influence of motor activity on the intensity and interference of chronic pain in women who have undergone mastectomy surgery due to resection of stage breast cancer. II and III.
Study population: women underwent unilateral or bilateral mastectomy due to resection of stage II and III breast cancer not followed by breast reconstruction aged 18 years or older who have not received chemotherapy or radiation.
Pain assessment Pain assessment is a multidimensional process, which must take into account all the components of suffering, both physically, psychologically and socially. The assessment of pain and motor activity of each participant in the study will be carried out 3 and 6 months after surgery. Pain will be assessed by administration of the following questionnaires: Numerical Rating Scale, Brief Inventory Pain.
The IPAQ (International Physical Activity Questionnaire) questionnaire measures the type and amount of physical activity that is normally done. The questions refer to the activity carried out in the last 7 days. It will be administered at 3 and 6 months after surgery.The expected duration of the study can be considered to be approximately 12 months.
Interference is a key biomarker for establishing adequate pain therapy. Pain intensity and interference will be both measured using questionnaires/scales such as the numerical Rating scale (NRS), the Brief Pain Inventory (BPI) will be assessed 12 and 24 weeks after mastectomy by administration of the following questionnaires: Numerical Rating Scale, Brief Inventory Pain. Physical activity will be assessed by means of the IPAQ questionnaire (International Physical Activity.
At the same timepoints (12 and 24 weeks after surgery) biomarkers of pain, inflammation (C-reactive protein, Interleukin-6, interleukin-8, tumor necrosis factor-alpha) and oxidative stress (superoxide dismutase, catalase and malondyaldheide) will be measured together with routinary blood parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women underwent unilateral or bilateral mastectomy due to resection of stage II and III breast cancer.
Key inclusion criteria (1 listed)
- over the age of 18 with a diagnosis of previous Stages I-III breast cancer.
Key exclusion criteria (5 listed)
- medical history of other types of cancer;
- disease related to the immune system (e.g. multiple sclerosis, HIV, lupus);
- recent symptoms of illness (cough, fever);
- waiting breast reconstruction;
- not chemotherapy or radiation during the first six months after surgery:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.
Time frame: Evaluation performed three and six months after surgery
Pain intensity self-measured using the Numerical Rating Scale (NRS). NRS is a 0-11 point-scale where the end points are the extremes of no pain (point 0) and worst pain as bad as it could be (point 10).
Effects of motor and/or sports activity on interference of chronic pain in women underwent mastectomy.
Time frame: Evaluation performed three and six months after surgery
Interference of pain in activities of daily living is a key biomarker for establishing adequate pain therapy. Interference of pain measured with the Brief Pain Inventory - Short Form. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily activities. Each item is scored on a 10 point numeric rating scale where 0 = no interference/pain and 10 = severe or complete interference/pain.
2 secondary outcomes
Biomarkers of inflammation.
Time frame: Evaluation performed three and six months after surgery
Biomarkers of oxidative stress
Time frame: Evaluation performed three and six months after surgery
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 6 Feb 2023.
- Background: PubMed 34685397Calapai M, Esposito E, Puzzo L, Vecchio DA, Blandino R, Bova G, Quattrone D, Mannucci C, Ammendolia I, Mondello C, Gangemi S, Calapai G, Cardia L. Post-Mastectomy Pain: An Updated Overview on Risk Factors, Predictors, and Markers. Life (Basel). 2021 Sep 29;11(10):1026. doi: 10.3390/life11101026.
- Background: PubMed 26267006Ambrose KR, Golightly YM. Physical exercise as non-pharmacological treatment of chronic pain: Why and when. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):120-30. doi: 10.1016/j.berh.2015.04.022. Epub 2015 May 23.
- Background: PubMed 21621130Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
- Background: PubMed 29966772Tait RC, Zoberi K, Ferguson M, Levenhagen K, Luebbert RA, Rowland K, Salsich GB, Herndon C. Persistent Post-Mastectomy Pain: Risk Factors and Current Approaches to Treatment. J Pain. 2018 Dec;19(12):1367-1383. doi: 10.1016/j.jpain.2018.06.002. Epub 2018 Jun 30.
- Background: PubMed 30586070Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
- Background: PubMed 3461421Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.
- Background: PubMed 29392241Schug SA, Bruce J. Risk stratification for the development of chronic postsurgical pain. Pain Rep. 2017 Oct 31;2(6):e627. doi: 10.1097/PR9.0000000000000627. eCollection 2017 Nov.
- Background: PubMed 17426506Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.
- Background: PubMed 33085012Kaushik AS, Strath LJ, Sorge RE. Dietary Interventions for Treatment of Chronic Pain: Oxidative Stress and Inflammation. Pain Ther. 2020 Dec;9(2):487-498. doi: 10.1007/s40122-020-00200-5. Epub 2020 Oct 21.
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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.
Gioacchino Calapai, MD study director
Azienda Ospedaliera Universitaria "G. Martino"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
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 1 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 6 Feb 2023. 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 Italy. 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?
Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy. (time frame: Evaluation performed three and six months after surgery). 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 NCT05713786, which also lists 9 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 6 Feb 2023.