Trial Outcomes & Findings for Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer (NCT NCT02137252)

Last Updated: 2021-11-16

Results Overview

Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-fatigue subscale): This 13-item self-report scale measuring fatigue and functional impairment as a result of fatigue has been validated in cancer patients (Cella et al. Cancer 2002;94:528-38) The scale is reverse-scored and the range is 0 (maximum fatigue) - 52 (minimum fatigue). According to ICD10 criteria, a score \<= 34 indicates significant cancer related fatigue. A change of 10 points has been shown to constitute a clinically meaningful difference on this subscale.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold

Results posted on

2021-11-16

Participant Flow

In the monitoring phase, eligibility for randomization was defined as FACIT-F subscale score \>=10 pre-radiation therapy and decrease in FACIT-F of 10 points.

Participant milestones

Participant milestones
Measure	Naltrexone The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.	Sugar Pill daily dose placebo for 5 week treatment period
Overall Study STARTED	2	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Naltrexone The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.	Sugar Pill daily dose placebo for 5 week treatment period
Overall Study trial terminated early	2	1

Baseline Characteristics

Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone n=2 Participants The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.	Placebo: Sugar Pill n=1 Participants daily dose placebo for 5 week treatment period	Total n=3 Participants Total of all reporting groups
Age, Continuous	49 Years n=5 Participants	59 Years n=7 Participants	52.3 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold

Population: trial terminated early

Outcome measures

Outcome data not reported

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Naltrexone n=2 participants at risk The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.	Sugar Pill n=1 participants at risk daily dose placebo for 5 week treatment period
Injury, poisoning and procedural complications Dermatitis radiation	100.0% 2/2 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	100.0% 1/1 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders fatigue	100.0% 2/2 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	100.0% 1/1 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders headache	50.0% 1/2 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/1 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders nausea	50.0% 1/2 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/1 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders dizziness	50.0% 1/2 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	100.0% 1/1 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders irritability	50.0% 1/2 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	100.0% 1/1 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders mental fogginess	50.0% 1/2 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	100.0% 1/1 • Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Additional Information

Fremonta Meyer, MD

Dana-Farber Cancer Institute/Brigham and Women's Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place