Trial Outcomes & Findings for Exercise Intervention for LGBT Cancer Survivors (NCT NCT02459769)

NCT ID: NCT02459769

Last Updated: 2023-11-18

Results Overview

Self-reported psychological distress was measured with the Profile of Mood States (POMS) total score among LGBT cancer survivors. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

140 participants

Primary outcome timeframe

Assessed at 8 weeks

Results posted on

2023-11-18

Participant Flow

Participant milestones

Participant milestones
Measure
Dyadic Exercise Intervention for LGBT Survivors
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Dyadic Exercise Intervention for Caregivers
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Caregivers-No Intervention
A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members
Overall Study
STARTED
34
32
34
33
Overall Study
COMPLETED
26
28
25
28
Overall Study
NOT COMPLETED
8
4
9
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Dyadic Exercise Intervention for LGBT Survivors
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Dyadic Exercise Intervention for Caregivers
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Caregivers-No Intervention
A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members
Overall Study
Withdrawal by Subject
7
4
8
5
Overall Study
Lost to Follow-up
1
0
1
0

Baseline Characteristics

Exercise Intervention for LGBT Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=32 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=31 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Dyadic Exercise Intervention for Caregivers
n=32 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Caregivers-No Intervention
n=31 Participants
A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members
Total
n=126 Participants
Total of all reporting groups
Age, Continuous
56.3 years
n=93 Participants
55.5 years
n=4 Participants
56.7 years
n=27 Participants
54.5 years
n=483 Participants
55.7 years
n=36 Participants
Sex/Gender, Customized
Male
8 Participants
n=93 Participants
13 Participants
n=4 Participants
9 Participants
n=27 Participants
11 Participants
n=483 Participants
41 Participants
n=36 Participants
Sex/Gender, Customized
Female
23 Participants
n=93 Participants
18 Participants
n=4 Participants
23 Participants
n=27 Participants
19 Participants
n=483 Participants
83 Participants
n=36 Participants
Sex/Gender, Customized
Transgender Female
1 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
1 Participants
n=36 Participants
Sex/Gender, Customized
Transgender Male
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
1 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
3 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
n=93 Participants
31 Participants
n=4 Participants
32 Participants
n=27 Participants
30 Participants
n=483 Participants
123 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=93 Participants
0 Participants
n=4 Participants
2 Participants
n=27 Participants
0 Participants
n=483 Participants
4 Participants
n=36 Participants
Race (NIH/OMB)
White
30 Participants
n=93 Participants
31 Participants
n=4 Participants
30 Participants
n=27 Participants
31 Participants
n=483 Participants
122 Participants
n=36 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Region of Enrollment
United States
32 Participants
n=93 Participants
31 Participants
n=4 Participants
32 Participants
n=27 Participants
31 Participants
n=483 Participants
126 Participants
n=36 Participants
Sexual Orientation
Lesbian or Gay
30 Participants
n=93 Participants
31 Participants
n=4 Participants
30 Participants
n=27 Participants
26 Participants
n=483 Participants
117 Participants
n=36 Participants
Sexual Orientation
Heterosexual or Straight
0 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
5 Participants
n=483 Participants
6 Participants
n=36 Participants
Sexual Orientation
Bisexual
1 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
1 Participants
n=36 Participants
Sexual Orientation
Other
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
0 Participants
n=483 Participants
2 Participants
n=36 Participants

PRIMARY outcome

Timeframe: Assessed at 8 weeks

Self-reported psychological distress was measured with the Profile of Mood States (POMS) total score among LGBT cancer survivors. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress.

Outcome measures

Outcome measures
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=32 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=31 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Self-Reported Psychological Distress
8.89 score on a scale
Standard Deviation 22.04
6.96 score on a scale
Standard Deviation 17.78

SECONDARY outcome

Timeframe: Assessed at 8 weeks

Population: Note that only 30 LGBT survivors from the Dyadic Exercise Intervention and only 27 from the Individual Exercise intervention had analyzable blood, which is why the total number of participants differs from other outcome measures.

The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: serum cortisol among LGBT cancer survivors.

Outcome measures

Outcome measures
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=30 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=27 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Biological Endpoints: Cortisol
42.97 ng/ml
Standard Deviation 25.83
59.20 ng/ml
Standard Deviation 49.21

SECONDARY outcome

Timeframe: Assessed at 8 weeks

Population: Note that only 30 LGBT survivors from the Dyadic Exercise Intervention and only 27 from the Individual Exercise intervention had analyzable blood, which is why the total number of participants differs from other outcome measures.

The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of early inflammation serum amyloid A (SAA) among LGBT cancer survivors.

Outcome measures

Outcome measures
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=30 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=27 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Biological Endpoints: Serum Amyloid A
666.27 ng/ml
Standard Deviation 219.98
968.26 ng/ml
Standard Deviation 1592.59

SECONDARY outcome

Timeframe: Assessed at 8 weeks

Population: Note that only 30 LGBT survivors from the Dyadic Exercise Intervention and only 27 from the Individual Exercise intervention had analyzable blood, which is why the total number of participants differs from other outcome measures.

The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of C-reactive protein (CRP) among LGBT cancer survivors.

Outcome measures

Outcome measures
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=30 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=27 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Biological Endpoints: C-reactive Protein
860440.91 pg/ml
Standard Deviation 2270252.50
133590.00 pg/ml
Standard Deviation 198748.60

SECONDARY outcome

Timeframe: Assessed at 8 weeks

Social support from the care partner was measured with the Dyadic Support Questionnaire (DSQ) among LGBT cancer survivors. The DSQ is an 18-item survey based on four functions of social support (emotional, appraisal, instrumental, and informational support). Nine items measure received social support, that is, support provided by the partner. Items are anchored using a Likert scale ranging from 1 to 5 (from not at all to a great deal). Items were summed to create a scale for received support ranging from 9-45, with higher scores indicating more support.

Outcome measures

Outcome measures
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=32 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=31 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Mechanistic Outcomes: Support
39.46 score on a scale
Standard Deviation 7.95
39.04 score on a scale
Standard Deviation 4.08

SECONDARY outcome

Timeframe: Assessed at 8 weeks

We also aim to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on social support from the care partners intervention adherence (actigraphy) among LGBT cancer survivors. The actigraph features a variable epoch length which can be set between 1 to 240 seconds. Software supplied by the manufacturer was used to determine number of minutes of moderate or higher activity during each assessment period.

Outcome measures

Outcome measures
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=32 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=31 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Mechanistic Outcomes: Adherence
12.57 minutes per day
Standard Deviation 7.55
15.55 minutes per day
Standard Deviation 9.60

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at 8 weeks

Self-reported psychological distress among caregivers of LGBT cancer survivors was determined using the Profile of Mood States (POMS) total score. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress.

Outcome measures

Outcome measures
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=32 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=31 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Self-Reported Distress Among Caregivers
2.65 score on a scale
Standard Deviation 16.03
6.21 score on a scale
Standard Deviation 17.58

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at 8 weeks

Population: Note that only 30 caregivers from the Dyadic Exercise Intervention and only 27 from the Individual Exercise intervention had analyzable blood, which is why the total number of participants differs from other outcome measures.

An exploratory aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress among caregivers of LGBT cancer survivors: serum cortisol.

Outcome measures

Outcome measures
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=30 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=27 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Biological Endpoints of Distress Among Caregivers
68.80 ng/ml
Standard Deviation 60.46
60.74 ng/ml
Standard Deviation 72.42

Adverse Events

Dyadic Exercise Intervention for LGBT Cancer Survivors

Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths

Individual Exercise Intervention for LGBT Cancer Survivors

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Dyadic Exercise Intervention for Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Individual Caregivers-No Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Dyadic Exercise Intervention for LGBT Cancer Survivors
n=32 participants at risk
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Exercise Intervention for LGBT Cancer Survivors
n=31 participants at risk
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Dyadic Exercise Intervention for Caregivers
n=32 participants at risk
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program
Individual Caregivers-No Intervention
n=31 participants at risk
A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members
Cardiac disorders
Serious Adverse Event
3.1%
1/32 • Number of events 1 • 8 weeks
0.00%
0/31 • 8 weeks
0.00%
0/32 • 8 weeks
0.00%
0/31 • 8 weeks

Other adverse events

Adverse event data not reported

Additional Information

Charles Kamen, PhD

University of Rochester

Phone: 585-275-9958

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place