Prehabilitation for Ovarian Cancer Patients

Ovarian Cancer Clinical Trial

Official title:

The Impact of Prehabilitation Exercise on Frailty and Treatment Outcomes in Ovarian Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364879
• Other study ID #: NSH Adv Ovarian Cancer Prehab
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: Nova Scotia Health Authority
• Contact: Scott Grandy, PhD
• Phone: 902-494-1145
• Email: grandy[@]dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Although there are best treatment practices to improve survival, some women have other conditions that limit treatment options. One such condition seen in as many as 50% of women with advanced ovarian cancer is frailty (an age-related decline in function and health). This is a major concern as doctors will often have to change how the cancer is treated based on the patient being frail. For example, patients living with frailty are less likely to have their full tumor removed during surgery. They are also more likely to have complications with surgery, stay in the hospital longer, and recover less well from surgery overall. Patients living with frailty also are more likely to experience delays in their chemotherapy starting, receive lower doses of chemotherapy and/or receive fewer cycles of chemotherapy. These changes in treatment may decrease how long a patient survives after diagnosis. Thus, research is needed to explore strategies to decrease frailty in patients who require treatment for advanced ovarian cancer. An option gaining more attention is physical exercise (e.g. walking, repeatedly rising from a chair). Exercise performed before surgery, which is called prehabilitation, can improve how well a patient recovers after surgery and increase how long they survive. Research has shown that prehabilitation is very beneficial for patients undergoing surgery for heart disease. However, it is not clear whether prehabilitation works for those with advanced ovarian cancer that are going to have surgery. Therefore, the investigators want to explore how a 4+ week exercise program performed while waiting for surgery for advanced ovarian cancer changes frailty and how a patient recovers after surgery. The investigators will specifically look whether the exercise program: 1) reduces how frail a patient is before surgery; 2) improves how well the patient recovers after surgery; and 3) affects the patient's chemotherapy treatment plan. This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ovarian cancer. Overall, it is believed that exercise has the potential to improve the survival of advanced ovarian cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older
• Have a confirmed diagnosis of stage III or IV ovarian cancer
• Scheduled to receive cytoreductive surgery as part of their treatment plan
• Must have a minimum of 4-weeks between the time of study enrollment and scheduled surgery
• Be able to attend in-person and/or virtual exercise sessions
• Be fluent in English
• Have oncologist approval

Exclusion Criteria:

• Have already completed surgery
• Unstable cardiac or respiratory disease, injury or any other co-morbid disease that may make it unsafe for participants to exercise
• Significant cognitive impairment (e.g., do not have the capacity to consent, unable to follow exercise instructions)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Enhanced Recovery After Surgery
• Exercise
• Frailty
• Ovarian Cancer
• Ovarian Neoplasms
• Prehabilitation
• Surgical Complication
• Treatment Outcomes

Intervention

Behavioral:
• Prehabilitation Exercise Intervention
The exercise intervention will consist of light-to-moderate intensity aerobic, resistance, and mobility exercises. These exercises will be performed in a circuit type manner. Participants will perform similar exercises that are modified to meet their individual abilities. Exercise intensity, modifications and substitutions will be determined for each participant based on their medical history, 6 minute walk test results, and baseline frailty scores. Exercise sessions will be performed 3x/wk beginning at 30 min and progressing to 60-min as tolerated for a minimum of four weeks but will continue up until the time of the participants surgery. A hybrid approach will be used for the exercise sessions whereby the participant must attend the first exercise session in person and subsequent sessions will be delivered virtually. Sessions will be overseen by the study Clinical Exercise Physiologist.

Locations

Country	Name	City	State
Canada	Nova Scotia Health	Halifax	Nova Scotia (NS)

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study Feasibility - Participant Accrual	Participant accrual calculated as % of patients referred divided by number of patients consented to participation	Throughout study completion, about 2 years
Other	Study Feasibility - Participant Attrition	Participant attrition calculated as % of consented patients who complete a minimum of 4 weeks of pre-surgical exercise divided by number who withdraw	Through study completion, about 2 years
Other	Study Feasibility - Participant Adherence	Participant program adherence calculated as % of minimum number of exercise sessions completed (e.g., 3 sessions/week for a minimum of 4 weeks for a total of 12 sessions) divided by total number of available exercise sessions over 12-week intervention	Throughout study completion, about 2 years
Other	Adverse Events	All exercise-related adverse and serious adverse will be recorded	Throughout study completion, about 2 years
Primary	Frailty Change (baseline to post exercise intervention)	Frailty will be assessed using the Clinical Frailty Scale (CFS). The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual. The CFS covers domains of mobility, energy, physical activity, and function. The higher the score on the CFS the more frail/less fit an individual is.	Change from baseline to end of 4+ week intervention (pre-surgery)
Primary	Frailty Change (baseline to 1-month post surgery)	Frailty will be assessed using the Clinical Frailty Scale (CFS). The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual. The CFS covers domains of mobility, energy, physical activity, and function. The higher the score on the CFS the more frail/less fit an individual is.	Change from baseline to about 1-month post-surgery
Primary	Frailty Change (baseline to 3-months post surgery)	Frailty will be assessed using the Clinical Frailty Scale (CFS). The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual. The CFS covers domains of mobility, energy, physical activity, and function. The higher the score on the CFS the more frail/less fit an individual is.	Change from baseline to about 3-month post-surgery
Primary	Surgical Complexity Score (1-month post surgery)	Surgical complexity will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Complexity scores will be interpreted as "low" (3 or fewer points), "intermediate" (4-7 points), and "high" (8 or more points).	Surgical complexity will be assessed about 1-month post-surgery.
Primary	Post-Surgical Outcomes (1-month post surgery)	Post-surgical outcomes will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Specific outcomes will include post-op glucose control, analgesia usage, pain, daily weight, early mobilization, and post-operative complications.	Post-surgical outcomes will be assessed about 1-month post-surgery.
Primary	Surgical Complications (1-month post surgery)	Surgical complications will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Specific outcomes will include length of hospital stay and number of readmissions.	Surgical complications will be assessed post-surgery about 1-month post-surgery.
Primary	Chemotherapy completion rates (End of Cycle 1)	Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment	At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure.
Primary	Chemotherapy completion rates (End of Cycle 2)	Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment	At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.
Primary	Chemotherapy completion rates (End of Cycle 3)	Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment	At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure.
Primary	Chemotherapy completion rates (End of Cycle 4)	Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment	At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.
Primary	Chemotherapy completion rates (End of Cycle 5)	Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment	At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure.
Primary	Chemotherapy completion rates (End of Cycle 6)	Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment	At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure.
Secondary	Body Mass Index Change (baseline to post exercise intervention)	Weight (kg) and height (m) will be used to calculate BMI	Change in BMI from baseline to post 4+ week exercise intervention
Secondary	Body Mass Index Change (baseline to 1-month post surgery)	Weight (kg) and height (m) will be used to calculate BMI	Change in BMI from baseline to about 1-month post surgery.
Secondary	Body Mass Index Change (baseline to 3-months post surgery)	Weight (kg) and height (m) will be used to calculate BMI	Change in BMI from baseline to about 3-month post surgery.
Secondary	Aerobic Fitness Change (baseline to post exercise intervention)	The six-minute walk will be used to calculate aerobic fitness	Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)
Secondary	Aerobic Fitness Change (baseline to 1-month post surgery)	The six-minute walk will be used to calculate aerobic fitness	Change in aerobic fitness from baseline to about 1-month post surgery
Secondary	Aerobic Fitness Change (baseline to 3-months post surgery)	The six-minute walk will be used to calculate aerobic fitness	Change in aerobic fitness from baseline to about 3-months post surgery
Secondary	Muscular Fitness Change (baseline to post exercise intervention)	Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.	Change in muscular fitness will be assessed from baseline to post exercise intervention (pre-surgery)
Secondary	Muscular Fitness Change (baseline to about 1-month post surgery)	Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.	Change in muscular fitness will be assessed from baseline to 1-month post surgery.
Secondary	Muscular Fitness Change (baseline to about 3-months post surgery)	Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.	Change in muscular fitness will be assessed from baseline to 3-months post surgery.
Secondary	Health-Related Quality of Life Change (baseline to post exercise intervention	Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L). The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems	Chang in health-related quality of life from baseline to post 4+ week intervention (pre-surgery)
Secondary	Health-Related Quality of Life Change (baseline to 1-month post surgery)	Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L). The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems	Chang in health-related quality of life from baseline to about 1-month post surgery
Secondary	Health-Related Quality of Life Change (baseline to 3-months post surgery)	Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L). The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems	Change in health-related quality of life from baseline to about 3-months post surgery
Secondary	Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to post exercise intervention)	The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.	Change in FACT-O from baseline to post 4+ week intervention (pre-surgery)
Secondary	Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 1-month post surgery)	The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.	Change in FACT-O from baseline to about 1-month post surgery
Secondary	Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 3-months post surgery)	The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.	Change in FACT-O from baseline to about 3-months post surgery

External Links

•   Laboratory website