Trial Outcomes & Findings for Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (NCT NCT03314688)

Results Overview

Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

173 participants

Primary outcome timeframe

before initiating chemotherapy to post-chemotherapy, up to 7 months

Results posted on

2025-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Dietary/Physical Activity Intervention Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). Dietary/Physical Activity intervention: Motivational counseling to follow established dietary and exercise guidelines.	Usual Care Group Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study. Usual Care: Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Overall Study STARTED	87	86
Overall Study Eligible for Endocrine Therapy	40	37
Overall Study COMPLETED	87	86
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dietary/Physical Activity Intervention n=87 Participants Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). Dietary/Physical Activity intervention: Motivational counseling to follow established dietary and exercise guidelines.	Usual Care Group n=86 Participants Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study. Usual Care: Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.	Total n=173 Participants Total of all reporting groups
Age, Continuous	52.3 years STANDARD_DEVIATION 11.3 • n=5 Participants	53.3 years STANDARD_DEVIATION 10.9 • n=7 Participants	52.8 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	86 Participants n=7 Participants	173 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 Race and Ethnicity · Non-Hispanic White	61 Participants n=5 Participants	62 Participants n=7 Participants	123 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Non-Hispanic Black	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Hispanic	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Asian or Pacific Islander	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Prefer not to answer	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	87 participants n=5 Participants	86 participants n=7 Participants	173 participants n=5 Participants
Study Site Yale	63 Participants n=5 Participants	59 Participants n=7 Participants	122 Participants n=5 Participants
Study Site Dana-Farber Cancer Institute	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Body Mass Index (BMI)	29.5 kg/m^2 STANDARD_DEVIATION 7.0 • n=5 Participants	29.8 kg/m^2 STANDARD_DEVIATION 6.6 • n=7 Participants	29.7 kg/m^2 STANDARD_DEVIATION 6.8 • n=5 Participants
Postmenopausal Status Postmenopausal: Yes	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Postmenopausal Status Postmenopausal: No	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Cancer Stage Stage I	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Cancer Stage Stage II	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Cancer Stage Stage III	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Receptor Status ER/PR+, HER2-	49 Participants n=5 Participants	50 Participants n=7 Participants	99 Participants n=5 Participants
Receptor Status ER/PR+/-, HER2+	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Receptor Status Triple negative	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Chemotherapy Neoadjuvant	41 Participants n=5 Participants	32 Participants n=7 Participants	73 Participants n=5 Participants
Chemotherapy Adjuvant	46 Participants n=5 Participants	54 Participants n=7 Participants	100 Participants n=5 Participants
Chemotherapy Cycles 4 (range of weeks: 8-12)	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Chemotherapy Cycles >4 (range of weeks: 12-24)	64 Participants n=5 Participants	61 Participants n=7 Participants	125 Participants n=5 Participants
Time since diagnosis	60 days STANDARD_DEVIATION 34 • n=5 Participants	68 days STANDARD_DEVIATION 32 • n=7 Participants	63 days STANDARD_DEVIATION 33 • n=5 Participants

PRIMARY outcome

Timeframe: before initiating chemotherapy to post-chemotherapy, up to 7 months

Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose.

Outcome measures

Outcome measures
Measure	Dietary/Physical Activity Intervention n=87 Participants Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). Dietary/Physical Activity intervention: Motivational counseling to follow established dietary and exercise guidelines.	Usual Care Group n=86 Participants Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study. Usual Care: Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Adherence to Treatment Measured by Chemotherapy Completion Rate	93.9 percentage of actual dose/planned dose Standard Deviation 12.1	93.6 percentage of actual dose/planned dose Standard Deviation 11.1

PRIMARY outcome

Timeframe: 12 months after enrollment

Population: Participants eligible for Endocrine Therapy.

This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. 1. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted) 2. In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) 3. In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)

Outcome measures

Outcome measures
Measure	Dietary/Physical Activity Intervention n=40 Participants Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). Dietary/Physical Activity intervention: Motivational counseling to follow established dietary and exercise guidelines.	Usual Care Group n=37 Participants Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study. Usual Care: Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) Q1. All the Time	29 Participants	23 Participants
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) Q2. Never	23 Participants	18 Participants
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) Q3. Never	35 Participants	29 Participants

PRIMARY outcome

Timeframe: 24 months after enrollment

Population: Participants eligible for Endocrine Therapy.

This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted- Q1) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q2) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q3)

Outcome measures

Outcome measures
Measure	Dietary/Physical Activity Intervention n=40 Participants Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). Dietary/Physical Activity intervention: Motivational counseling to follow established dietary and exercise guidelines.	Usual Care Group n=37 Participants Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study. Usual Care: Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). Q1. = All the Time	22 Participants	22 Participants
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). Q2. = Never	20 Participants	18 Participants
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). Q3. = Never	33 Participants	25 Participants

SECONDARY outcome

Timeframe: At the time of surgical resection following initial course of chemotherapy

In the subset of patients receiving neoadjuvant chemotherapy, no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Assessed by fasting blood (fast of 12 hours or more).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Assessed by fasting blood (fast of 12 hours or more).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Assessed by fasting blood (fast of 12 hours or more).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Assessed by fasting blood (fast of 12 hours or more).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Assessed by fasting blood (fast of 12 hours or more).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Assessed by fasting blood (fast of 12 hours or more).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Assessed by fasting blood (fast of 12 hours or more).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Assessed by fasting blood (fast of 12 hours or more).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Assessed by measured weight

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Assessed from measured weight and measured height

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Assessed by measured weight

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Assessed from measured weight and measured height

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Assessed by measured weight

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Assessed from measured weight and measured height

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Assessed by measured weight

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Assessed from measured weight and measured height

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Assessed by dual energy X-ray absorptiometry (DEXA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-chemotherapy)

Assessed by stool collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 months from treatment onset

Assessed by stool collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year post-diagnosis

Assessed by stool collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years post-diagnosis

Assessed by stool collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: five years post-diagnosis

Assessed by food frequency questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: five years post-diagnosis

Assessed by the modified physical activity questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Dietary/Physical Activity Intervention

Serious events: 45 serious events

Other events: 78 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 47 serious events

Other events: 70 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Dietary/Physical Activity Intervention n=87 participants at risk Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). Dietary/Physical Activity intervention: Motivational counseling to follow established dietary and exercise guidelines.	Usual Care Group n=86 participants at risk Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the 2-year study. Women will also be offered a counselling session with a registered study dietician at the end of the study. Usual Care: Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Gastrointestinal disorders Severity of dry mouth	17.1% 14/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	18.9% 14/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of difficulty swallowing	2.4% 2/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	8.1% 6/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Infections and infestations Severity of mouth or throat sores	4.9% 4/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	6.8% 5/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Infections and infestations Inference of mouth or throat sores	1.2% 1/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	6.8% 5/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Nervous system disorders Severity of problems with tasting	20.7% 17/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	21.6% 16/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Metabolism and nutrition disorders Severity of decreased appetite	17.1% 14/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	9.5% 7/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Metabolism and nutrition disorders Inference of decreased appetite	8.5% 7/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	9.5% 7/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Frequency of nausea	12.2% 10/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	9.5% 7/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of nausea	9.8% 8/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	6.8% 5/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of vomiting	1.2% 1/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	2.7% 2/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Frequency of heartburn	15.9% 13/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	17.6% 13/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of heartburn	9.8% 8/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	9.5% 7/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of constipation	14.6% 12/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	12.2% 9/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Frequency of diarrhea	15.9% 13/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	16.2% 12/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.

Other adverse events

Additional Information

Tara Sanft, MD

Yale School of Medicine

Phone: (203) 200-2328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dietary/Physical Activity Intervention n=87 participants at risk Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). Dietary/Physical Activity intervention: Motivational counseling to follow established dietary and exercise guidelines.	Usual Care Group n=86 participants at risk Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the 2-year study. Women will also be offered a counselling session with a registered study dietician at the end of the study. Usual Care: Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Gastrointestinal disorders Severity of dry mouth	56.1% 46/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	59.5% 44/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of difficulty swallowing	28.0% 23/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	27.0% 20/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Infections and infestations Severity of mouth or throat sores	37.8% 31/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	40.5% 30/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Infections and infestations Inference of mouth or throat sores	18.3% 15/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	25.7% 19/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Nervous system disorders Severity of problems with tasting	70.7% 58/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	70.3% 52/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Metabolism and nutrition disorders Severity of decreased appetite	47.6% 39/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	52.7% 39/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Metabolism and nutrition disorders Inference of decreased appetite	29.3% 24/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	36.5% 27/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Frequency of nausea	50.0% 41/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	37.8% 28/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of nausea	48.8% 40/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	28.4% 21/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Frequency of vomiting	12.2% 10/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	6.8% 5/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of vomiting	9.8% 8/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	8.1% 6/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Frequency of heartburn	50.0% 41/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	50.0% 37/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of heartburn	41.5% 34/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	41.9% 31/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Severity of constipation	39.0% 32/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	33.8% 25/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.
Gastrointestinal disorders Frequency of diarrhea	50.0% 41/82 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.	44.6% 33/74 • Up to 24 months PRO-CTCAE was used to assess participant Adverse Events.