Trial Outcomes & Findings for Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer (NCT NCT03180294)

Last Updated: 2022-03-08

Results Overview

The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

230 participants

Primary outcome timeframe

Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)

Results posted on

2022-03-08

Participant Flow

Registered patients who completed required baseline assessments were randomized. Of 238 registered patients, 230 were randomized.

Participant milestones

Participant milestones
Measure	Bupropion 150 mg One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Overall Study STARTED	79	74	77
Overall Study Eligible Population	79	74	77
Overall Study Adverse Event Population	77	73	76
Overall Study COMPLETED	79	74	77
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupropion 150 mg n=79 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=74 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL PO in a.m. daily for 1 week (titration off)	Placebo n=77 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)	Total n=230 Participants Total of all reporting groups
Age, Continuous	54.63 years STANDARD_DEVIATION 7.61 • n=5 Participants	54.68 years STANDARD_DEVIATION 9.05 • n=7 Participants	58.1 years STANDARD_DEVIATION 8.00 • n=5 Participants	55.8 years STANDARD_DEVIATION 8.35 • n=4 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	74 Participants n=7 Participants	77 Participants n=5 Participants	230 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	69 Participants n=7 Participants	72 Participants n=5 Participants	215 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	70 Participants n=7 Participants	67 Participants n=5 Participants	211 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Zubrod 0	70 Participants n=5 Participants	70 Participants n=7 Participants	66 Participants n=5 Participants	206 Participants n=4 Participants
Zubrod 1	9 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	24 Participants n=4 Participants
Current Selective Serotonin Reuptake Inhibitors (SSRI) Use No	69 Participants n=5 Participants	69 Participants n=7 Participants	66 Participants n=5 Participants	204 Participants n=4 Participants
Current Selective Serotonin Reuptake Inhibitors (SSRI) Use Yes	10 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	26 Participants n=4 Participants
Prior Pelvic Radiation Therapy No	70 Participants n=5 Participants	72 Participants n=7 Participants	68 Participants n=5 Participants	210 Participants n=4 Participants
Prior Pelvic Radiation Therapy Yes	9 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	20 Participants n=4 Participants
Prior Pelvic Surgery No	56 Participants n=5 Participants	54 Participants n=7 Participants	48 Participants n=5 Participants	158 Participants n=4 Participants
Prior Pelvic Surgery Yes	23 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants	72 Participants n=4 Participants
Aromatase Inhibitor therapy No	44 Participants n=5 Participants	37 Participants n=7 Participants	42 Participants n=5 Participants	123 Participants n=4 Participants
Aromatase Inhibitor therapy Yes	35 Participants n=5 Participants	37 Participants n=7 Participants	35 Participants n=5 Participants	107 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)

Population: Eligible participants with baseline and 9 week data

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=66 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=59 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=63 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire")	0.64 units on a scale Standard Deviation 0.95	0.60 units on a scale Standard Deviation 0.89	0.62 units on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)

Population: Eligible with baseline data

The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=79 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=74 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=77 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score Week 5	-2.29 units on a scale Standard Deviation 7.05	-1.11 units on a scale Standard Deviation 7.63	-0.30 units on a scale Standard Deviation 6.71
Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score Week 9	-3.28 units on a scale Standard Deviation 9.46	-3.14 units on a scale Standard Deviation 7.88	-3.42 units on a scale Standard Deviation 6.59

SECONDARY outcome

Timeframe: Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization)

Population: Eligible with baseline and 5 week data

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=66 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=61 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=63 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Change From Baseline at 5 Weeks in Desire Subscore of the FSFI ("Sexual Desire")	0.70 units on a scale Standard Deviation 0.90	0.48 units on a scale Standard Deviation 0.69	0.58 units on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)

Population: Eligible with baseline data

The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the "PROMIS sexual desire and satisfaction measure" in the protocol.

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=79 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=74 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=76 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction") Week 5	3.35 units on a scale Standard Deviation 7.27	2.81 units on a scale Standard Deviation 5.82	3.08 units on a scale Standard Deviation 6.00
Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction") Week 9	2.05 units on a scale Standard Deviation 6.51	2.72 units on a scale Standard Deviation 4.72	3.58 units on a scale Standard Deviation 6.93

SECONDARY outcome

Timeframe: Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)

Population: Eligible with baseline data

The FSFI total score measures self-reported female sexual functioning covering the major domains arousal, satisfaction, and orgasm, and including lubrication and pain. Possible scores range from 2 to 36, with higher scores indicating better functioning. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased functioning. This measure is referred to as "sexual functioning" in the protocol.

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=78 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=74 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=77 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Change From Baseline in FSFI Total Score ("Sexual Functioning") Week 5	3.84 units on a scale Standard Error 7.84	4.01 units on a scale Standard Error 6.08	3.53 units on a scale Standard Error 7.48
Change From Baseline in FSFI Total Score ("Sexual Functioning") Week 9	3.29 units on a scale Standard Error 7.66	3.55 units on a scale Standard Error 6.63	4.70 units on a scale Standard Error 8.36

SECONDARY outcome

Timeframe: Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)

Population: Eligible with baseline data

The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as "depressive mood" in the protocol.

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=79 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=74 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=77 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood") Week 5	-0.44 units on a scale Standard Error 1.77	-0.17 units on a scale Standard Error 1.91	-0.16 units on a scale Standard Error 2.29
Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood") Week 9	-0.42 units on a scale Standard Error 1.68	-0.43 units on a scale Standard Error 1.86	-0.43 units on a scale Standard Error 2.39

SECONDARY outcome

Timeframe: 9 weeks from start of study treatment (within 21 days of randomization)

Population: Eligible with data

Participants are asked, "Since beginning the study agent, my desire of sexual intimacy is:" with seven possible answers of "very much better," "moderately better," "a little better," "about the same," "a little worse," "moderately worse," and "very much worse." The first three answers have been categorized as "Better' and the last three answers as "Not Better". This measure is referred to as "perception of change" in the protocol.

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=66 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=60 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=63 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Global Impression of Change at 9 Weeks ("Perception of Change") Not Better	43 Participants	36 Participants	43 Participants
Global Impression of Change at 9 Weeks ("Perception of Change") Better	23 Participants	24 Participants	20 Participants

SECONDARY outcome

Timeframe: 9 weeks from start of study treatment (within 21 days of randomization)

Population: Eligible with data

Participants are asked, "Were the benefits of this treatment greater than any side effects?"

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=67 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=58 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=61 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Perception of Risk vs. Benefit at 9 Weeks No	37 Participants	32 Participants	40 Participants
Perception of Risk vs. Benefit at 9 Weeks Yes	30 Participants	26 Participants	21 Participants

SECONDARY outcome

Timeframe: Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).

Population: Eligible with adverse event data and started study treatment.

Common Terminology Criteria for Adverse Events (version 4) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure.; see Adverse Events Module for specific adverse event data.

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=77 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=73 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=76 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study	4 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 9 weeks from start of study treatment (within 21 days of randomization).

Population: Eligible with 9 week data

Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).

Outcome measures

Outcome measures
Measure	Bupropion 150 mg n=57 Participants One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=52 Participants One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=56 Participants One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Severity of nausea at its worst = very severe	0 Participants	0 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Severity of constipation at its worst = very severe	0 Participants	0 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Severity of dizziness at its worst = very severe	0 Participants	0 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Interference of dizziness with usual or daily activities = very much	0 Participants	0 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Frequency of headache = almost constantly	0 Participants	0 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Severity of headache at its worst = very severe	0 Participants	1 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Interference of headache with usual or daily activities = very much	0 Participants	1 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Severity of insomnia at it's worst = very severe	0 Participants	0 Participants	1 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Interference of insomnia with usual or daily activities = very much	0 Participants	0 Participants	1 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Severity of dry mouth at its worst = very severe	0 Participants	0 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Severity of decreased appetite at its worst= very severe	0 Participants	0 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Interference of decreased appetite with usual or daily activities = very much	0 Participants	0 Participants	0 Participants
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Frequency of nausea = almost constantly	1 Participants	0 Participants	0 Participants

Adverse Events

Bupropion 150 mg

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

Bupropion 300 mg

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bupropion 150 mg n=77 participants at risk One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=73 participants at risk One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=76 participants at risk One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Psychiatric disorders Insomnia	1.3% 1/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	0.00% 0/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	0.00% 0/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.

Other adverse events

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Bupropion 150 mg n=77 participants at risk One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).	Bupropion 300 mg n=73 participants at risk One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)	Placebo n=76 participants at risk One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Psychiatric disorders Libido decreased	1.3% 1/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	0.00% 0/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	5.3% 4/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.3% 1/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	1.4% 1/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	5.3% 4/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Ear and labyrinth disorders Tinnitus	5.2% 4/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	0.00% 0/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	2.6% 2/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Gastrointestinal disorders Constipation	29.9% 23/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	32.9% 24/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	26.3% 20/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Gastrointestinal disorders Diarrhea	5.2% 4/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	4.1% 3/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	10.5% 8/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Gastrointestinal disorders Dry mouth	27.3% 21/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	41.1% 30/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	32.9% 25/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	5.5% 4/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	1.3% 1/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Gastrointestinal disorders Nausea	15.6% 12/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	19.2% 14/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	28.9% 22/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
General disorders Fatigue	6.5% 5/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	8.2% 6/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	6.6% 5/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
General disorders Pain	5.2% 4/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	1.4% 1/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	3.9% 3/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Metabolism and nutrition disorders Anorexia	16.9% 13/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	20.5% 15/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	26.3% 20/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 2/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	2.7% 2/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	9.2% 7/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Nervous system disorders Dizziness	11.7% 9/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	17.8% 13/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	18.4% 14/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Nervous system disorders Headache	29.9% 23/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	49.3% 36/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	39.5% 30/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Nervous system disorders Tremor	5.2% 4/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	5.5% 4/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	7.9% 6/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Psychiatric disorders Anxiety	5.2% 4/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	6.8% 5/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	3.9% 3/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Psychiatric disorders Depression	5.2% 4/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	4.1% 3/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	5.3% 4/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Psychiatric disorders Insomnia	31.2% 24/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	37.0% 27/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	38.2% 29/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 11/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	12.3% 9/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	18.4% 14/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	3.9% 3/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	1.4% 1/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	9.2% 7/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	6.5% 5/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	2.7% 2/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	5.3% 4/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
Vascular disorders Hot flashes	6.5% 5/77 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	9.6% 7/73 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.	7.9% 6/76 • 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).] All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.